| Trial | Outcome |
|---|
| NCT00527644 (1) [back to overview] | No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan. |
| NCT00989781 (5) [back to overview] | 17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls |
| NCT00989781 (5) [back to overview] | Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls |
| NCT00989781 (5) [back to overview] | Anti-Mullerian Hormone (AMH) |
| NCT00989781 (5) [back to overview] | Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls |
| NCT00989781 (5) [back to overview] | 17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels. |
| NCT01062568 (3) [back to overview] | Free Testosterone Response to ACTH |
| NCT01062568 (3) [back to overview] | Androstenedione Response to ACTH |
| NCT01062568 (3) [back to overview] | 17-hydroxyprogesterone Response to ACTH |
| NCT01129284 (2) [back to overview] | Sustained Remissions up to 1 Year After Discontinuing Therapy |
| NCT01129284 (2) [back to overview] | Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below) |
| NCT01386554 (2) [back to overview] | Percentage of Participants With Sustained Remission |
| NCT01386554 (2) [back to overview] | Percentage of Participants With Complete or Partial Remission in Proteinuria at 24 Weeks |
| NCT01428336 (3) [back to overview] | Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs |
| NCT01428336 (3) [back to overview] | Pearson Correlation of Free Cortisol Values During CSTs With ITT |
| NCT01428336 (3) [back to overview] | Peak Total Cortisol Values |
| NCT01601236 (10) [back to overview] | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria |
| NCT01601236 (10) [back to overview] | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death |
| NCT01601236 (10) [back to overview] | Complete or Partial Remission of Proteinuria |
| NCT01601236 (10) [back to overview] | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol |
| NCT01601236 (10) [back to overview] | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) |
| NCT01601236 (10) [back to overview] | Percent Change From Baseline in eGFR by Visit |
| NCT01601236 (10) [back to overview] | Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 |
| NCT01601236 (10) [back to overview] | Percent Change in eGFR at Visit 17 |
| NCT01601236 (10) [back to overview] | Change in Mean HbA1c |
| NCT01601236 (10) [back to overview] | Percent Change in eGFR Calculated Using Cystatin C |
| NCT01647581 (1) [back to overview] | Number of Patients With Delayed Post Polypectomy Bleeding |
| NCT01753401 (17) [back to overview] | Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52 |
| NCT01753401 (17) [back to overview] | Krupp Fatigue Severity Score (FSS) at Week 52 |
| NCT01753401 (17) [back to overview] | Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52 |
| NCT01753401 (17) [back to overview] | Number of Participants Who Meet the Definition of a Responder Within 8 Weeks |
| NCT01753401 (17) [back to overview] | Score on the SELENA-SLEDAI Within 8 Weeks |
| NCT01753401 (17) [back to overview] | Number of Tender or Swollen Joints Within 8 Weeks |
| NCT01753401 (17) [back to overview] | Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks |
| NCT01753401 (17) [back to overview] | Mean Score on the Mental Component Scale (MCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks |
| NCT01753401 (17) [back to overview] | Krupp Fatigue Severity Score (FSS) Within 8 Weeks |
| NCT01753401 (17) [back to overview] | Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks |
| NCT01753401 (17) [back to overview] | BILAG Total Score Within 8 Weeks |
| NCT01753401 (17) [back to overview] | Score on the SELENA-SLEDAI at Week 52 |
| NCT01753401 (17) [back to overview] | Number of Tender or Swollen Joints at Week 52 |
| NCT01753401 (17) [back to overview] | Mean Score on the Mental Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52 |
| NCT01753401 (17) [back to overview] | Number of Participants With a Relapse Within 52 Weeks |
| NCT01753401 (17) [back to overview] | Number of Participants Who Meet the Definition of a Responder Within 4 Weeks |
| NCT01753401 (17) [back to overview] | Number of Participants Who Meet the Definition of a Responder at Week 52 |
| NCT01906372 (2) [back to overview] | Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI). |
| NCT01906372 (2) [back to overview] | Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients. |
| NCT01906658 (4) [back to overview] | Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication |
| NCT01906658 (4) [back to overview] | Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication |
| NCT01906658 (4) [back to overview] | Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation |
| NCT01906658 (4) [back to overview] | Proportion of Subjects With Treatment Emergent Suicidality |
| NCT01938989 (1) [back to overview] | Photostress Recovery Time |
| NCT01948388 (5) [back to overview] | Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings |
| NCT01948388 (5) [back to overview] | Evaluation of MRI Structural Improvements |
| NCT01948388 (5) [back to overview] | Number of Participants With Increased or Decreased Erosions of the Hand and Wrist |
| NCT01948388 (5) [back to overview] | Change From Baseline in Clinical Disease Activity Index (CDAI) Score |
| NCT01948388 (5) [back to overview] | Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR) |
| NCT01966718 (4) [back to overview] | Change From Baseline in the Ritchey-Camp Articular Index |
| NCT01966718 (4) [back to overview] | Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) |
| NCT01966718 (4) [back to overview] | Change From Baseline in the C-Reactive Protein (CRP) Level |
| NCT01966718 (4) [back to overview] | Change From Baseline in the 20-item Health Assessment Questionnaire Score |
| NCT02030028 (5) [back to overview] | Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 |
| NCT02030028 (5) [back to overview] | Patient Reported Changes in Fatigue Between Week 0 and Week 12 |
| NCT02030028 (5) [back to overview] | Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12 |
| NCT02030028 (5) [back to overview] | Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12 |
| NCT02030028 (5) [back to overview] | Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12 |
| NCT02057523 (2) [back to overview] | 50% Reduction in Proteinuria or Proteinuria < 150mg/Day |
| NCT02057523 (2) [back to overview] | 25% Improvement in the MDRD eGFR |
| NCT02132195 (3) [back to overview] | Number of Adverse Events |
| NCT02132195 (3) [back to overview] | Number of Participants Experienced a Relapse of Nephrotic Syndrome |
| NCT02132195 (3) [back to overview] | Number of Participants Experiencing Relapses After Dose Reduction of ACTH |
| NCT02219997 (3) [back to overview] | Change in Braking Reaction Time From No-glare to Glare |
| NCT02219997 (3) [back to overview] | Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF) |
| NCT02219997 (3) [back to overview] | Change in Braking Reaction Time From No-glare to Glare (Clear IOLs) |
| NCT02258217 (9) [back to overview] | SAGE (Self-administered Gerocognitive Exam) Scores |
| NCT02258217 (9) [back to overview] | ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores) |
| NCT02258217 (9) [back to overview] | MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score. |
| NCT02258217 (9) [back to overview] | MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score |
| NCT02258217 (9) [back to overview] | ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living) |
| NCT02258217 (9) [back to overview] | ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores) |
| NCT02258217 (9) [back to overview] | ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health) |
| NCT02258217 (9) [back to overview] | EDSS (Expanded Disability Status Scale) Scores. |
| NCT02258217 (9) [back to overview] | GASE Scale Questionnaire (Generic Assessment of Side Effects) |
| NCT02290444 (9) [back to overview] | Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) |
| NCT02290444 (9) [back to overview] | Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II) |
| NCT02290444 (9) [back to overview] | Change From Baseline on the Expanded Disability Status Scale (EDSS). |
| NCT02290444 (9) [back to overview] | Change From Baseline on the Fatigue Severity Scale (FSS) |
| NCT02290444 (9) [back to overview] | Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) |
| NCT02290444 (9) [back to overview] | Change From Baseline on the Symbol Digit Modalities Test (SDMT) |
| NCT02290444 (9) [back to overview] | Timed 25-foot Walk |
| NCT02290444 (9) [back to overview] | Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS) |
| NCT02290444 (9) [back to overview] | Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) |
| NCT02315872 (4) [back to overview] | Quality of Life at 28 Weeks |
| NCT02315872 (4) [back to overview] | Depression at 28 Weeks |
| NCT02315872 (4) [back to overview] | Sleepiness at 28 Weeks |
| NCT02315872 (4) [back to overview] | Fatigue at 28 Weeks |
| NCT02446886 (4) [back to overview] | Change in T2 Lesion Volume |
| NCT02446886 (4) [back to overview] | Longitudinal Assessment of MWF |
| NCT02446886 (4) [back to overview] | Physical Disability as Measured by EDSS |
| NCT02446886 (4) [back to overview] | Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months |
| NCT02546492 (2) [back to overview] | Safety (Serious Adverse Events) |
| NCT02546492 (2) [back to overview] | Efficacy Outcome |
| NCT02633046 (1) [back to overview] | Number of Participants With Adverse Events |
| NCT02725177 (4) [back to overview] | Proportion of Patients Experiencing a Tapering of Ocular/Oral Steroids by at Least 50% |
| NCT02725177 (4) [back to overview] | Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema |
| NCT02725177 (4) [back to overview] | Percentage of Patients With Clinically Significant Improvement in Visual Acuity |
| NCT02725177 (4) [back to overview] | Percentage of Patients With Clinically Significant Improvement in the Resolution-intraocular Inflammation |
| NCT02764697 (1) [back to overview] | Number of Participants With Clinically Significant Improvement of Macular Edema |
| NCT02769702 (2) [back to overview] | Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination |
| NCT02769702 (2) [back to overview] | Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation |
| NCT02919761 (14) [back to overview] | Part 1: Patient-Reported General Health by Visit |
| NCT02919761 (14) [back to overview] | Part 1: Tender Joint Count by Visit |
| NCT02919761 (14) [back to overview] | Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit |
| NCT02919761 (14) [back to overview] | Part 1: Number of Participants With Low Disease Activity (LDA) by Visit |
| NCT02919761 (14) [back to overview] | Part 2: Patient-Reported General Health by Visit |
| NCT02919761 (14) [back to overview] | Part 2: Number of Participants Who Maintained Low Disease Activity by Visit |
| NCT02919761 (14) [back to overview] | Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit |
| NCT02919761 (14) [back to overview] | Part 1: Swollen Joint Count by Visit |
| NCT02919761 (14) [back to overview] | Part 1: Physician's Global Assessment of Disease Activities by Visit |
| NCT02919761 (14) [back to overview] | Part 1: Patient's Global Assessment of Pain by Visit |
| NCT02919761 (14) [back to overview] | Part 2: Tender Joint Count by Visit |
| NCT02919761 (14) [back to overview] | Part 2: Swollen Joint Count by Visit During Part 2 |
| NCT02919761 (14) [back to overview] | Part 2: Physician's Global Assessment of Disease Activities by Visit |
| NCT02919761 (14) [back to overview] | Part 2: Patient's Global Assessment of Pain by Visit |
| NCT02941640 (6) [back to overview] | Time of Application |
| NCT02941640 (6) [back to overview] | Operative Time |
| NCT02941640 (6) [back to overview] | Intra-perative Complications |
| NCT02941640 (6) [back to overview] | Hospital Stay |
| NCT02941640 (6) [back to overview] | Postoperative Complications |
| NCT02941640 (6) [back to overview] | Overall Morbidity |
| NCT02953821 (7) [back to overview] | Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) |
| NCT02953821 (7) [back to overview] | Mean Number of Swollen or Tender Joints on the 28-Joint Count |
| NCT02953821 (7) [back to overview] | Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score |
| NCT02953821 (7) [back to overview] | British Isles Lupus Assessment Group 2004 (BILAG 2004) |
| NCT02953821 (7) [back to overview] | Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16 |
| NCT02953821 (7) [back to overview] | Physician's Global Assessment (PGA) |
| NCT02953821 (7) [back to overview] | Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24 |
| NCT03025828 (5) [back to overview] | Number of Participants With Complete or Partial Remission |
| NCT03025828 (5) [back to overview] | Estimated Glomerular Filtration Rate (GFR) |
| NCT03025828 (5) [back to overview] | Change in Serum Albumin |
| NCT03025828 (5) [back to overview] | Change in Proteinuria |
| NCT03025828 (5) [back to overview] | Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio |
| NCT03068754 (6) [back to overview] | Treatment Period: Spirometry (%) |
| NCT03068754 (6) [back to overview] | Treatment Period: Scores on a Scale for Telephone-administered Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) |
| NCT03068754 (6) [back to overview] | Treatment Period: Scores on a Scale for Investigator-administered ALSFRS-R |
| NCT03068754 (6) [back to overview] | Number of Participants Experiencing an Adverse Event During the Treatment Period |
| NCT03068754 (6) [back to overview] | Number of Participants Experiencing an Adverse Event by the End of the Trial in the OLE Period |
| NCT03068754 (6) [back to overview] | Extension Period: Scores on a Scale for Investigator-administered ALSFRS-R |
| NCT03126760 (1) [back to overview] | Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42 |
| NCT03287635 (3) [back to overview] | Intraocular Pressure |
| NCT03287635 (3) [back to overview] | Dry Eye Comfort Questionnaire, SANDE |
| NCT03287635 (3) [back to overview] | 1. Conjunctival Staining With Lissamine Green |
| NCT03320070 (12) [back to overview] | OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48 |
| NCT03320070 (12) [back to overview] | OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48 |
| NCT03320070 (12) [back to overview] | OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48 |
| NCT03320070 (12) [back to overview] | OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48 |
| NCT03320070 (12) [back to overview] | OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48 |
| NCT03320070 (12) [back to overview] | DBT: Number of Participants in Each Category of Assessment Based on the King's Sarcoidosis Questionnaire (KSQ) (General Health), a Quality of Life Parameter at Week 24 |
| NCT03320070 (12) [back to overview] | DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24 |
| NCT03320070 (12) [back to overview] | DBT: Number of Participants in Each Category of Assessment Based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter at Week 24 |
| NCT03320070 (12) [back to overview] | DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24 |
| NCT03320070 (12) [back to overview] | DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24 |
| NCT03320070 (12) [back to overview] | DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24 |
| NCT03320070 (12) [back to overview] | OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48 |
| NCT04169061 (1) [back to overview] | Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12] |
| NCT04398537 (4) [back to overview] | Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. |
| NCT04398537 (4) [back to overview] | Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site. |
| NCT04398537 (4) [back to overview] | Average Distance of Clip Migration for the Arm That Received 5mm Retraction. |
| NCT04398537 (4) [back to overview] | Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction. |
No Leak, Subclinical Leak or Clinical Bile Leak on Post-operative Hepato-iminodiacetic Acid (HIDA) Scan.
(NCT00527644)
Timeframe: By post op day one HIDA scan.
| Intervention | Participants (Count of Participants) |
|---|
| Spring Clips | 14 |
17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls
Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection (NCT00989781)
Timeframe: Baseline and 24 hours after hCG
| Intervention | ng/ml (Mean) |
|---|
| NR-PCOS Women | 1.3 |
| HR-PCOS Women | 3 |
| Normal Women | 1.1 |
Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls
3-D ultrasound was not assessed; instead 2-D ultrasound was performed (NCT00989781)
Timeframe: baseline
| Intervention | Antral Follicle Count (Mean) |
|---|
| NR-PCOS Women | 64.4 |
| HR-PCOS Women | 49.3 |
| Normal Women | 31.8 |
Anti-Mullerian Hormone (AMH)
(NCT00989781)
Timeframe: Baseline
| Intervention | ng/ml (Mean) |
|---|
| NR-PCOS Women | 16.0 |
| HR-PCOS Women | 6.7 |
| Normal Women | 5.3 |
Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls
17-hydroxyprogesterone response to ACTH infusion in women with PCOS and normal women. Response is reported as a single value generated by summing the data at end time frame. (NCT00989781)
Timeframe: Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH
| Intervention | ng/ml (Mean) |
|---|
| NR-PCOS Women | 6.0 |
| HR-PCOS Women | 8.1 |
| Normal Women | 6.2 |
17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.
17 hydroxyprogesterone levels (NCT00989781)
Timeframe: Baseline and 24 after hCG
| Intervention | Participants (Count of Participants) |
|---|
| NR-PCOS Women | 0 |
| HR-PCOS Women | 0 |
| Normal Women | 0 |
Free Testosterone Response to ACTH
Free Testosteorne levels before and after ACTH (NCT01062568)
Timeframe: 0 and 60 min after ACTH administration
,
| Intervention | pmol/L (Mean) |
|---|
| Normal weight | Overweight |
|---|
| Early Puberty Group | 2 | 3.5 |
| Late Puberty Group | 7 | 32 |
Androstenedione Response to ACTH
Androstenedione levels before and after ACTH (NCT01062568)
Timeframe: 0 and 60 min after ACTH administration
,
| Intervention | ng/mL (Mean) |
|---|
| Normal Wieght | Overweight |
|---|
| Early Puberty | 0.5 | 0.6 |
| Late Puberty | 1.6 | 3.1 |
17-hydroxyprogesterone Response to ACTH
17-hyrooxyprogesterone levels before and after ACTH (NCT01062568)
Timeframe: 0 and 60 minutes after ACTH administration
,,
| Intervention | ng/mL (Mean) |
|---|
| Normal Weight | Over Weight |
|---|
| Early Puberty Group | 2.4 | 2.9 |
| Late Puberty Group | 3.7 | 3.1 |
| Total Number | 3.1 | 3.0 |
Sustained Remissions up to 1 Year After Discontinuing Therapy
Complete remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at last follow-up visit (6 to 12 months post treatment). Partial remission defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at last follow-up visit (6 to 12 months post treatment). (NCT01129284)
Timeframe: Up to 1 year after treatment
| Intervention | participants (Number) |
|---|
| Membranous Nephropathy | 3 |
| FSGS/MCD | 2 |
| IgA Nephropathy | 2 |
Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below)
Complete remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with proteinuria falling <500 mg/day at month 6. Partial remission is defined as stable or improved renal function, serum creatinine < or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at month 6. (NCT01129284)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Membranous Nephropathy | 2 |
| FSGS/MCD | 2 |
| IgA Nephropathy | 3 |
Percentage of Participants With Sustained Remission
The participant's response was considered the average of the two PCR values from the 24-hour urine collections at Visit 8 (Week 24). (NCT01386554)
Timeframe: At Visit 9 (Week 28)
| Intervention | Participants (Count of Participants) |
|---|
| Acthar 40U | 1 |
| Acthar 80U | 4 |
| Combined Placebo | 2 |
Percentage of Participants With Complete or Partial Remission in Proteinuria at 24 Weeks
The participant's response was considered the average of the two PCR values from the 24-hour urine collected at Visit 8 (Week 24). Urine protein creatinine ratio (uPCR) was used to assess remission (partial and complete). Complete remission = uPCR < 0.3 g/g; partial remission = uPCR < 50% of baseline uPCR and > 0.3 g/g but < 3.0 g/g. (NCT01386554)
Timeframe: At Visit 8 (Week 24)
,,
| Intervention | Participants (Count of Participants) |
|---|
| Partial remission in proteinuria | Complete remission in proteinuria |
|---|
| Acthar 40U | 1 | 0 |
| Acthar 80U | 5 | 0 |
| Combined Placebo | 2 | 0 |
Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs
Correlation of total cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table (NCT01428336)
Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions
| Intervention | correlation coefficient (Number) |
|---|
| Peak 1 ug ACTH stimulation test | Peak 25 ug ACTH stimultion test | 60-minute 250ug ACTH stimulation test | 30-minute 250ug ACTH stimulation test |
|---|
| Patients + Volunteers | 0.8 | 0.86 | 0.93 | 0.92 |
Pearson Correlation of Free Cortisol Values During CSTs With ITT
Correlation of free cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table (NCT01428336)
Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions
| Intervention | correlation coefficient (Number) |
|---|
| Peak 1ug ACTH stimulation test | Peak 25ug ACTH stimulation test | 60- minute 250ug ACTH stimulation test | 30-minute 250ug ACTH stimulation test |
|---|
| Patients + Volunteers | 0.58 | 0.70 | 0.88 | 0.89 |
Peak Total Cortisol Values
Peak total cortisol values during cortrosyn stimulation tests(CST) (NCT01428336)
Timeframe: 1 hour for the CST interventions and 2 hour for the ITT interventions
,
| Intervention | ug/dl (Median) |
|---|
| Insulin Tolerance Test | 1 ug ACTH stimulation test | 25 ug ACTH stimulation test | 30 min 250 ug ACTH stimulation test | 60 min 250 ug ACTH simulation test |
|---|
| Patients | 23.3 | 23.4 | 22.0 | 22.3 | 25.0 |
| Volunteers | 16.6 | 14.5 | 17.4 | 16.1 | 19.1 |
Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria
Proportion of subjects whose best response was complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria (NCT01601236)
Timeframe: Visit 12 (Week 36) and Visit 17 (Week 52)
| Intervention | Participants (Count of Participants) |
|---|
| Week 3672027592 | Week 3672027590 | Week 3672027591 | Between Week 36 and Week 5272027590 | Between Week 36 and Week 5272027591 | Between Week 36 and Week 5272027592 |
|---|
| Complete remission | Partial remission | No remission |
|---|
| Placebo | 0 |
| Acthar 8 Units | 0 |
| Acthar 16 Units | 1 |
| Placebo | 1 |
| Acthar 16 Units | 3 |
| Placebo | 9 |
| Acthar 8 Units | 7 |
| Acthar 16 Units | 12 |
| Acthar 16 Units | 2 |
| Placebo | 8 |
| Acthar 8 Units | 2 |
| Acthar 16 Units | 5 |
Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death
(NCT01601236)
Timeframe: Visit 12 (Week 36) and Visit 17 (Week 52)
| Intervention | Participants (Count of Participants) |
|---|
| Visit 12 (Week 36)72027591 | Visit 12 (Week 36)72027592 | Visit 12 (Week 36)72027590 | Visit 17 (Week 52)72027591 | Visit 17 (Week 52)72027592 | Visit 17 (Week 52)72027590 |
|---|
| Yes | No |
|---|
| Acthar 8 Units | 1 |
| Acthar 16 Units | 1 |
| Acthar 8 Units | 6 |
| Acthar 16 Units | 15 |
| Placebo | 0 |
| Acthar 16 Units | 2 |
| Placebo | 10 |
| Acthar 16 Units | 14 |
Complete or Partial Remission of Proteinuria
Proportion of patients with complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria at Visit 12 (Week 36) and/or at Visit 17 (Week 52) (NCT01601236)
Timeframe: Visit 12 (Week 36) and Visit 17 (Week 52)
| Intervention | Participants (Count of Participants) |
|---|
| Visit 12 (Week 36)72027590 | Visit 12 (Week 36)72027592 | Visit 12 (Week 36)72027591 | Visit 17 (Week 52)72027590 | Visit 17 (Week 52)72027591 | Visit 17 (Week 52)72027592 |
|---|
| No remission | Complete remission | Partial remission |
|---|
| Placebo | 0 |
| Acthar 16 Units | 1 |
| Placebo | 1 |
| Acthar 16 Units | 0 |
| Placebo | 8 |
| Acthar 8 Units | 3 |
| Acthar 16 Units | 7 |
| Acthar 8 Units | 0 |
| Placebo | 6 |
| Acthar 8 Units | 2 |
Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol
Percent change from baseline of serum total cholesterol, triglycerides, LDL, HDL, Lp(a), albumin, and cortisol (NCT01601236)
Timeframe: Visit 6, 9, 12, and 17
,,
| Intervention | percent change (Mean) |
|---|
| Total cholesterol - Baseline to Visit 6 | Total cholesterol - Baseline to Visit 9 | Total cholesterol - Baseline to Visit 12 | Total cholesterol - Baseline to Week 36 Endpoint | Total cholesterol - Baseline to Visit 17 | Total cholesterol - Baseline to Week 52 Endpoint | Triglycerides - Baseline to Visit 6 | Triglycerides - Baseline to Visit 9 | Triglycerides - Baseline to Visit 12 | Triglycerides - Baseline to Week 36 Endpoint | Triglycerides - Baseline to Visit 17 | Triglycerides - Baseline to Week 52 Endpoint | LDL-C - Baseline to Visit 6 | LDL-C - Baseline to Visit 9 | LDL-C - Baseline to Visit 12 | LDL-C - Baseline to Week 36 Endpoint | LDL-C - Baseline to Visit 17 | LDL-C - Baseline to Week 52 Endpoint | HDL-C - Baseline to Visit 6 | HDL-C - Baseline to Visit 9 | HDL-C - Baseline to Visit 12 | HDL-C - Baseline to Week 36 Endpoint | HDL-C - Baseline to Visit 17 | HDL-C - Baseline to Week 52 Endpoint | Lp(a) - Baseline to Visit 6 | Lp(a) - Baseline to Visit 9 | Lp(a) - Baseline to Visit 12 | Lp(a) - Baseline to Week 36 Endpoint | Lp(a) - Baseline to Visit 17 | Lp(a) - Baseline to Week 52 Endpoint | Serum albumin - Baseline to Visit 6 | Serum albumin - Baseline to Visit 9 | Serum albumin - Baseline to Visit 12 | Serum albumin - Baseline to Week 36 Endpoint | Serum albumin - Baseline to Visit 17 | Serum albumin - Baseline to Week 52 Endpoint | Cortisol - Baseline to Visit 6 | Cortisol - Baseline to Visit 9 | Cortisol - Baseline to Visit 12 | Cortisol - Baseline to Week 36 Endpoint | Cortisol - Baseline to Visit 17 | Cortisol - Baseline to Week 52 Endpoint |
|---|
| Acthar 16 Units | 10.1 | 14.2 | 11.1 | 12.9 | 9.6 | 9.4 | 20.5 | 31.0 | 29.2 | 19.9 | 27.7 | 18.2 | 8.1 | 24.5 | 26.4 | 12.4 | 25.9 | 24.1 | 18.1 | 3.4 | -6.9 | 19.0 | -9.2 | -3.2 | 22.7 | 28.0 | 10.7 | 16.9 | 21.7 | 21.2 | -3.78 | -3.75 | -4.09 | -7.23 | -2.33 | -2.75 | 180.70 | 50.08 | 52.77 | 64.32 | 7.09 | 30.21 |
| Acthar 8 Units | 34.1 | 20.3 | 11.1 | 26.4 | -12.1 | 26.8 | 30.0 | 7.9 | -7.1 | 48.8 | -37.4 | 33.5 | 47.4 | 36.1 | 23.2 | 42.0 | -9.9 | 43.2 | 11.8 | 9.8 | 11.4 | 6.7 | 3.0 | -0.2 | 35.9 | 1.2 | 23.3 | 49.2 | 19.9 | 55.6 | -9.79 | -7.77 | -2.67 | -5.96 | 8.06 | -6.15 | 45.08 | 14.44 | 17.72 | 63.46 | 84.26 | 51.82 |
| Placebo | -7.2 | 13.9 | 3.4 | 3.9 | 6.3 | 6.3 | 1.6 | 18.4 | 8.3 | 8.9 | 22.6 | 22.6 | -4.8 | 16.9 | 16.0 | 15.9 | 7.4 | 7.4 | -3.2 | 0.0 | 3.7 | 2.8 | -5.0 | -5.0 | -7.2 | 1.9 | 6.1 | 7.5 | 28.5 | 28.5 | -1.92 | -2.49 | -0.89 | -1.42 | -0.22 | -1.77 | -5.86 | -11.23 | -9.44 | -8.36 | -13.11 | -8.53 |
Percent Change From Baseline in Protein to Creatinine Ratio (PCR)
Percent change from baseline in PCR (NCT01601236)
Timeframe: Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17
,,
| Intervention | percent change (Mean) |
|---|
| Baseline to Visit 4 | Baseline to Visit 5 | Baseline to Visit 6 | Baseline to Visit 7 | Baseline to Visit 8 | Baseline to Visit 9 | Baseline to Visit 10 | Baseline to Visit 11 | Baseline to Visit 12 | Baseline to Week 36 Endpoint | Baseline to Visit 14 | Baseline to Visit 15 | Baseline to Visit 16 | Baseline to Visit 17 | Baseline to Week 52 Endpoint |
|---|
| Acthar 16 Units | 32.5701 | 2.0594 | -1.6086 | -10.6879 | -8.5381 | 3.6409 | -6.7500 | 0.4566 | 14.4619 | 50.2732 | -16.4956 | 0.0091 | 3.6555 | -6.2356 | 12.1049 |
| Acthar 8 Units | 44.7508 | 47.4429 | 72.1740 | 55.9950 | 53.2134 | 82.7319 | 18.9898 | 69.8646 | 59.8357 | 34.8848 | 11.7663 | 4.3807 | 21.7536 | 19.1625 | 66.7698 |
| Placebo | 0.3837 | -13.6630 | -8.3326 | 2.4621 | 12.6601 | 27.1483 | 8.2594 | 15.1205 | 21.3540 | 19.1847 | 1.1894 | 0.6294 | 0.0025 | 20.8644 | 32.9735 |
Percent Change From Baseline in eGFR by Visit
Percent change from baseline in eGFR by visit (NCT01601236)
Timeframe: Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17
,,
| Intervention | percent change (Mean) |
|---|
| Baseline to Visit 3 | Baseline to Visit 4 | Baseline to Visit 5 | Baseline to Visit 6 | Baseline to Visit 7 | Baseline to Visit 8 | Baseline to Visit 9 | Baseline to Visit 10 | Baseline to Visit 11 | Baseline to Visit 12 | Baseline to Week 36 Endpoint | Baseline to Visit 13 | Baseline to Visit 14 | Baseline to Visit 15 | Baseline to Visit 16 | Baseline to Visit 17 | Baseline to Week 52 Endpoint |
|---|
| Acthar 16 Units | 0.86 | -2.69 | -12.01 | -14.20 | -17.33 | -17.58 | -23.25 | -20.57 | -19.05 | -18.32 | -17.55 | -23.46 | -29.96 | -19.95 | -27.33 | -24.55 | -22.44 |
| Acthar 8 Units | 1.82 | 4.39 | -10.11 | -9.36 | -25.42 | -27.46 | -21.04 | -28.73 | -26.13 | -23.54 | -20.27 | -29.37 | -33.99 | -38.05 | -40.18 | -42.70 | -36.50 |
| Placebo | -6.19 | -11.76 | -8.42 | -12.73 | -12.30 | -11.64 | -14.46 | -15.75 | -14.71 | -26.09 | -24.96 | -17.94 | -21.88 | -17.40 | -19.16 | -18.43 | -20.69 |
Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12
Percent change in eGFR at Visit 12 (Week 36) compared to average baseline eGFR obtained during screening (NCT01601236)
Timeframe: Visit 12 (Week 36)
| Intervention | percent change (Least Squares Mean) |
|---|
| Placebo | -24.927 |
| Acthar 8 Units | -20.563 |
| Acthar 16 Units | -17.447 |
Percent Change in eGFR at Visit 17
Percent change in eGFR at Visit 17 (Week 52) compared to baseline eGFR obtained during screening (NCT01601236)
Timeframe: Visit 17 (Week 52)
| Intervention | percent change (Least Squares Mean) |
|---|
| Placebo | -20.407 |
| Acthar 8 Units | -37.456 |
| Acthar 16 Units | -22.097 |
Change in Mean HbA1c
Change from baseline mean HbA1c (%) to Week 36 (NCT01601236)
Timeframe: Week 36
| Intervention | %HbA1c (Mean) |
|---|
| Placebo | -0.22 |
| Acthar 8 Units | -0.33 |
| Acthar 16 Units | -0.25 |
Percent Change in eGFR Calculated Using Cystatin C
Percent change in eGFR calculated using cystatin C compared to baseline obtained at Visit 2. (NCT01601236)
Timeframe: Visit 12 (Week 36) and Visit 17 (Week 52)
,,
| Intervention | percent change (Mean) |
|---|
| Visit 12 (Week 36) | Visit 17 (Week 52) |
|---|
| Acthar 16 Units | -10.24 | -12.43 |
| Acthar 8 Units | -11.49 | -35.90 |
| Placebo | -14.25 | 1.14 |
Number of Patients With Delayed Post Polypectomy Bleeding
rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery (NCT01647581)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Clip | 12 |
| No Clip | 15 |
Krupp Fatigue Severity Score (FSS) at Week 52
"The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 (completely disagree) to 7 (completely agree) to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from no fatigue to fatigue as bad as could be. Higher scores on the scale are indicative of more severe fatigue.~This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue)." (NCT01753401)
Timeframe: at Week 52
| Intervention | score on a scale (Mean) |
|---|
| Placebo/Acthar | 4.523 |
| Acthar/Acthar | 4.743 |
Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52
The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease. (NCT01753401)
Timeframe: at Week 52
| Intervention | score on a scale (Mean) |
|---|
| Placebo/Acthar | 0.4 |
| Acthar/Acthar | 1.3 |
Number of Participants Who Meet the Definition of a Responder Within 8 Weeks
"Participants are counted as responders based on:~decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG" (NCT01753401)
Timeframe: within 8 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Placebo | 3 |
| Acthar | 11 |
Score on the SELENA-SLEDAI Within 8 Weeks
"SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI).~The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.~Rows: Week 2, Week 4, Week 6, Week 8" (NCT01753401)
Timeframe: within 8 weeks
,
| Intervention | score on a scale (Median) |
|---|
| Week 2 | Week 4 | Week 6 | Week 8 |
|---|
| Acthar | 8.0 | 8.0 | 6.0 | 6.0 |
| Placebo | 10.0 | 9.0 | 8.0 | 9.0 |
Number of Tender or Swollen Joints Within 8 Weeks
The doctor counted the number of tender or swollen joints at Baseline, at Week 4, and at Week 8 (NCT01753401)
Timeframe: at Baseline, Week 4, and Week 8 (within 8 weeks)
,
| Intervention | Tender or Swollen Joints (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 |
|---|
| Acthar | 9.6 | 4.5 | 3.5 |
| Placebo | 6.2 | 3.8 | 4.0 |
Krupp Fatigue Severity Score (FSS) Within 8 Weeks
"The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 (completely disagree) to 7 (completely agree) to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from no fatigue to fatigue as bad as could be. Higher scores on the scale are indicative of more severe fatigue.~This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue).~Rows: at Baseline, at Week 4, at Week 8" (NCT01753401)
Timeframe: at Baseline, Week 4 and Week 8 (within 8 weeks)
,
| Intervention | score on a scale (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 |
|---|
| Acthar | 5.648 | 5.298 | 5.152 |
| Placebo | 5.374 | 5.379 | 5.404 |
Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks
"The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease.~Rows: at Baseline, at Week 4, at Week 8" (NCT01753401)
Timeframe: at Baseline, Week 4 and Week 8 (within 8 weeks)
,
| Intervention | score on a scale (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 |
|---|
| Acthar | 6.4 | 4.8 | 3.7 |
| Placebo | 6.1 | 6.3 | 5.7 |
BILAG Total Score Within 8 Weeks
"The BILAG is a transitional index that captures changing severity of clinical manifestations that produces an overview of disease activity across eight systems.~The 8 systems are scored on a scale from 0=not present to 4=worse, for the 4 week period before the assessment. The lowest possible score is 0, and the highest possible score is 32. A higher score means the symptoms are worse.~Rows: Baseline, Week 4, Week 8" (NCT01753401)
Timeframe: within 8 weeks
,
| Intervention | score on a scale (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 |
|---|
| Acthar | 15.7 | 9.2 | 6.8 |
| Placebo | 15.4 | 10.3 | 13.5 |
Score on the SELENA-SLEDAI at Week 52
"SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI).~The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity." (NCT01753401)
Timeframe: at Week 52
| Intervention | score on a scale (Median) |
|---|
| Placebo/Acthar | 3 |
| Acthar/Acthar | 4 |
Number of Tender or Swollen Joints at Week 52
The doctor counted the number of tender or swollen joints at Week 52. (NCT01753401)
Timeframe: at Week 52
| Intervention | Tender or Swollen Joints (Mean) |
|---|
| Placebo/Acthar | 1.1 |
| Acthar/Acthar | 0.7 |
Number of Participants With a Relapse Within 52 Weeks
(NCT01753401)
Timeframe: within 52 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Placebo/Acthar | 1 |
| Acthar/Acthar | 6 |
Number of Participants Who Meet the Definition of a Responder Within 4 Weeks
"Participants are counted as responders based on two SLE indices: the Systemic Lupus Erythematosus Disease Activity Index amended by the SELENA group (SELENA-SLEDAI) and the British Isles Lupus Assessment Group (BILAG) Index.~decrease in SELENA-SLEDAI score from 4 to 0 for the arthritis descriptor (highest possible score is 4) and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash (highest possible score is 2) and no worsening in other organ systems based on BILAG~The BILAG is a transitional index that captures changing severity of clinical manifestations. It has an ordinal scale scoring system by design that produces an overview of disease activity across eight systems. The individual system scores were not intended to be summated into a global score." (NCT01753401)
Timeframe: within 4 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Placebo | 3 |
| Acthar | 4 |
Number of Participants Who Meet the Definition of a Responder at Week 52
"Participants are counted as responders based on:~decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG" (NCT01753401)
Timeframe: at Week 52
| Intervention | Participants (Count of Participants) |
|---|
| Placebo/Acthar | 4 |
| Acthar/Acthar | 3 |
Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).
3 of any of the 6 core set measures (CSM) improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (worsening measure cannot include the MMT). The DOI should be met at least once on any of the 6 follow up visits and maintained until week 24. Subjects not meeting DOI during the trial are treatment failures. (NCT01906372)
Timeframe: Primary end point: IMACS preliminary definition of improvement (DOI)
| Intervention | Participants (Count of Participants) |
|---|
| Acthar Gel | 7 |
Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients.
Mean change in glucocorticoid dose (equivalent prednisone dose) at 24 weeks compared to baseline. (NCT01906372)
Timeframe: Steroid sparing effect and safety and tolerability at 24 weeks compared to baseline
| Intervention | mg (Mean) |
|---|
| Follow Up 24 weeks | Baseline |
|---|
| Acthar Gel | 2.3 | 18.5 |
Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication
(NCT01906658)
Timeframe: Baseline to Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Acthar 80 U (1.0 mL) SC Twice Weekly | 2 |
| Acthar 24 U (0.3 mL) SC Daily | 0 |
| Acthar 56 U (0.7 mL) SC Twice Weekly | 2 |
| Acthar 16 U (0.2 mL) SC Daily | 0 |
Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication
(NCT01906658)
Timeframe: Baseline to Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Acthar 80 U (1.0 mL) SC Twice Weekly | 0 |
| Acthar 24 U (0.3 mL) SC Daily | 0 |
| Acthar 56 U (0.7 mL) SC Twice Weekly | 0 |
| Acthar 16 U (0.2 mL) SC Daily | 0 |
Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation
(NCT01906658)
Timeframe: Baseline to Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Acthar 80 U (1.0 mL) SC Twice Weekly | 2 |
| Acthar 24 U (0.3 mL) SC Daily | 0 |
| Acthar 56 U (0.7 mL) SC Twice Weekly | 2 |
| Acthar 16 U (0.2 mL) SC Daily | 0 |
Proportion of Subjects With Treatment Emergent Suicidality
(NCT01906658)
Timeframe: Baseline to Week 36
| Intervention | Participants (Count of Participants) |
|---|
| Acthar 80 U (1.0 mL) SC Twice Weekly | 1 |
| Acthar 24 U (0.3 mL) SC Daily | 3 |
| Acthar 56 U (0.7 mL) SC Twice Weekly | 0 |
| Acthar 16 U (0.2 mL) SC Daily | 0 |
Photostress Recovery Time
Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed. (NCT01938989)
Timeframe: Day 1
| Intervention | seconds (Mean) |
|---|
| Blue Light Filter | 5.66 |
| Clear | 6.94 |
Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings
"Comparison of the clinical findings as measured by the Clinical Disease Activity Index (CDAI) versus the structural findings as measured by Magnetic Resonance Imaging (MRI). Improvement is measured as a reduction in CDAI score from Baseline to Month 6 and improvement in MRI is regression of erosions, oseitis and synovitis at month 6. Norman MRI score is zero (0).~CDAI: 0.0-2.8 remission; 2.9-10.0 low disease activity; 10.1-22 moderate disease activity; 22.1-76 high disease activity. A decrease in CDAI score is improvement" (NCT01948388)
Timeframe: Month 6
,
| Intervention | participants (Number) |
|---|
| # of patients whose CDAI score improved | # of patients whose overall MRI improved |
|---|
| Group 1 | 8 | 6 |
| Group 2 | 8 | 5 |
Evaluation of MRI Structural Improvements
To compare the number of patients who have synovitis, oseitis and erosions at Baseline, Month 3 and Month 6. Normal range for synovitis, osteitis and erosions is zero (0) (NCT01948388)
Timeframe: Baseline, 3 months, 6 months
,
| Intervention | participants (Number) |
|---|
| Baseline : synovitis | Baseline : osteitis | Baseline : erosions | Month 3 : synovitis | Month 3 : osteitis | Month 3 : erosions | Month 6 : synovitis | Month 6 : osteitis | Month 6 : erosions |
|---|
| Group 1 | 8 | 8 | 9 | 6 | 6 | 9 | 5 | 4 | 7 |
| Group 2 | 7 | 4 | 8 | 7 | 6 | 8 | 7 | 4 | 8 |
Number of Participants With Increased or Decreased Erosions of the Hand and Wrist
"Comparison of the change in the number of erosions seen in the joints of the hand and wrist as measured by Magnetic Resonance Imaging (MRI) findings.~Regression indicates improvement in the number of erosions seen from Baseline and Progression indicates worsening in the number of erosions seen from Baseline. Normal range is zero (0)." (NCT01948388)
Timeframe: Month 3 and Month 6
,
| Intervention | participants (Number) |
|---|
| Month 3 : Progressed erosions | Month 3 : Regressed erosions | Month 6 : Progressed erosions | Month 6 : Regressed erosions |
|---|
| Group 1 | 1 | 0 | 2 | 1 |
| Group 2 | 3 | 2 | 2 | 2 |
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
To evaluate the effect of the use of 2 doses of corticotrophin (ACTH) as a treatment in patients with early onset rheumatoid arthritis as an alternative to conventional steroid therapy by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores. The CDAI is calculated at the specified time points using the formula: CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) Interpretation: A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity.Total range is from 0-100, with the high scores representing high disease activity. (NCT01948388)
Timeframe: Baseline, Month 3 and Month 6
| Intervention | Participants (Count of Participants) |
|---|
| Baseline72173377 | Baseline72173376 | Month 372173376 | Month 372173377 | Month 672173377 | Month 672173376 |
|---|
| remission | moderate disease activity | low disease activity | high disease activity |
|---|
| Group 2 | 0 |
| Group 1 | 9 |
| Group 2 | 8 |
| Group 1 | 3 |
| Group 2 | 1 |
| Group 1 | 2 |
| Group 2 | 4 |
| Group 2 | 2 |
| Group 1 | 0 |
| Group 2 | 3 |
| Group 1 | 4 |
| Group 1 | 1 |
Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)
comparisons not statistical analysis will be made from Baseline and Month 6 of the C- reactive Protein (CRP) values and Erythrocyte Sedimentation Rate (ESR) to determine the number of patients whose test result improved or worsenedCRP value (normal range <1.0 mg/dl). ESR (normal range 0-28 mm/hr) . If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved. (NCT01948388)
Timeframe: Month 6
| Intervention | Participants (Count of Participants) |
|---|
| CRP Values72173379 | CRP Values72173378 | ESR Values72173378 | ESR Values72173379 |
|---|
| # of patient with Decreased values | # of patients with Increased values |
|---|
| Group 1 | 8 |
| Group 2 | 7 |
| Group 1 | 1 |
| Group 2 | 1 |
| Group 1 | 9 |
| Group 2 | 8 |
| Group 1 | 0 |
| Group 2 | 0 |
Change From Baseline in the Ritchey-Camp Articular Index
Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points. (NCT01966718)
Timeframe: From baseline to week 16
| Intervention | joints (Mean) |
|---|
| Swollen Joints | 10.25 |
| Tender Joints | 9 |
Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)
ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased (NCT01966718)
Timeframe: From baseline to week 16
| Intervention | mm/hr (Mean) |
|---|
| Repository Corticotropin Injection | 1.9 |
Change From Baseline in the C-Reactive Protein (CRP) Level
CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline. (NCT01966718)
Timeframe: From baseline to week 16
| Intervention | mg/dL (Mean) |
|---|
| Repository Corticotropin Injection | 0.19 |
Change From Baseline in the 20-item Health Assessment Questionnaire Score
"Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from able to do with no difficulties to unable to do. A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16." (NCT01966718)
Timeframe: From baseline to week 16
| Intervention | units on a scale (Mean) |
|---|
| Repository Corticotropin Injection | 0.03 |
Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12
percentage of participants achieving >20% improvement in CDAI after 12 weeks of therapy (>20% reduction in CDAI relative to baseline based on ratio of CDAI at week 12 to CDAI at week 0: CDAI Week 12/CDAI Week 0 < 0.8 meets criteria for improvement, as lower CDAI scores represent lower disease activity) (NCT02030028)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| ACTHAR Gel | 8 |
Patient Reported Changes in Fatigue Between Week 0 and Week 12
The FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) scoring metric assesses fatigue using 13 questions rated on a Likert scale of 0 (no fatigue)-4 (severe fatigue); total scores range from 0-52, with higher total scores representing more severe fatigue. The difference in FACIT-F scores between weeks 12 and week 0 (calculated as FACIT-F score week 12 minus FACIT-F score at week 0) indicates changes in fatigue relative to baseline, where reduction of FACIT-F score at week 12 represents improvement in fatigue. (NCT02030028)
Timeframe: 12 weeks
| Intervention | units on a scale (Median) |
|---|
| ACTHAR Gel | -3.8 |
Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12
Change in ESR--reduction in ESR at week 12 relative to baseline (week 0) represents improvement (week 12 ESR - baseline ERS < 0) (NCT02030028)
Timeframe: 12 weeks
| Intervention | mm/hr (Mean) |
|---|
| ACTHAR Gel | -7.38 |
Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12
"Change in the Disease Activity Score 28-CRP (DAS28-CRP) at week 12 relative to baseline (week 0), where lower DAS28-CRP scores at week 12 represent improvement.~Scale: 0-8.61 (lower scores indicate reduced disease activity)" (NCT02030028)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| ACTHAR Gel | -0.87 |
Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12
Changes in C-reactive protein value (mg/dl): reduction in CRP values at week 12 relative to week 0 represents improvement (week 12 CRP-baseline CRP < 0)) (NCT02030028)
Timeframe: 12 weeks
| Intervention | mg/dl (Mean) |
|---|
| ACTHAR Gel | 0.36 |
50% Reduction in Proteinuria or Proteinuria < 150mg/Day
(NCT02057523)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Acthar | 1 |
25% Improvement in the MDRD eGFR
(NCT02057523)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Acthar | 1 |
Number of Adverse Events
Adverse events will be collected (SAEs and AEs) (NCT02132195)
Timeframe: 12 months
| Intervention | number of events (Number) |
|---|
| Adrenocorticotropic Hormone (ACTH) | 12 |
| No Treatment | 4 |
| Rescue Therapy | 17 |
Number of Participants Experienced a Relapse of Nephrotic Syndrome
Number of participants experienced a relapse of nephrotic syndrome during the initial 6 months of the study. (NCT02132195)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Adrenocorticotropic Hormone (ACTH) | 14 |
| No Treatment | 15 |
Number of Participants Experiencing Relapses After Dose Reduction of ACTH
The dose of ACTH will be reduced by 50% after 6 months and the rate of relapse during this period will be evaluated. (NCT02132195)
Timeframe: 6 to 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Adrenocorticotropic Hormone (ACTH) | 0 |
| Rescue Therapy | 0 |
Change in Braking Reaction Time From No-glare to Glare
Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. (NCT02219997)
Timeframe: Visit 2, up to Day 30
| Intervention | seconds (Mean) |
|---|
| AcrySof IQ IOL | 0.07 |
| Clear IOL | 0.15 |
Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)
Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. (NCT02219997)
Timeframe: Visit 2, Up to Day 30
| Intervention | seconds (Mean) |
|---|
| ACRYSOF IQ IOL + Placebo Filter | 0.12 |
| Clear IOL + BLF | 0.16 |
Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)
Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only. (NCT02219997)
Timeframe: Visit 2, Up to Day 30
| Intervention | seconds (Mean) |
|---|
| Placebo Filter | 0.17 |
| Blue Light Filter | 0.16 |
SAGE (Self-administered Gerocognitive Exam) Scores
"The Self-Administered Gerocognitive Exam (SAGE) is designed to detect early signs of cognitive, memory or thinking impairments. It evaluates your thinking abilities and helps physicians to know how well your brain is working.~It consists of 12 questions which are scored at different scales. The final SAGE score is calculated as a sum of these 12 questions and it ranges from 0 to 22.~Higher score indicates better outcome." (NCT02258217)
Timeframe: baseline and follow-up
| Intervention | score on a scale (Median) |
|---|
| SAGE (new relapse) | SAGE (after treatment of new relapse) |
|---|
| Single Arm | 21 | 21 |
ARMS (Assessing Relapses in Multiple Sclerosis) TCS Scores (Total Composite Scores)
"Patients completed the ARMS survey after treatment for the new relapse.The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability.~The TCS score was calculated only for the time point after treatment of relapse. It was a sum of questions 4 (symptom improvement), 5 (ADL), and 6 (return to previous state of health (RSH)) were evaluated. Scores range from 0 to 30 units, with higher scores representing greater improvement/better functioning." (NCT02258217)
Timeframe: Follow-up visit
| Intervention | score on a scale (Mean) |
|---|
| Single Arm | 14.3 |
MSIS (Multiple Sclerosis Impact Scale) - 29 Psychological Score.
"The MSIS-29 is a self-reported questionnaire in which MS patients answer a series of 29 questions designed to capture the impact of multiple sclerosis on their life over the past 2 weeks (11). Twenty of the 29 questions assess the physical impact of MS and 9 questions assess the psychological impact of MS.~The psychological impact of MS was compared between pre and post phase using paired t-tests.~The psychological impact of MS was compared between pre and post phase using paired t-tests.~The score was on a scale of 9 to 45 points for MSIS psychological score.~Higher score indicate worse outcome." (NCT02258217)
Timeframe: baseline visit & follow-up after treatment
| Intervention | score on a scale (Mean) |
|---|
| MSIS psychological(new relapse) | MSIS psychological(after treatment of new relapse) |
|---|
| Single Arm | 29.4 | 26.3 |
MSIS (Multiple Sclerosis Impact Scale) -29 Physical Score
"The MSIS-29 is a self-reported questionnaire in which MS patients answer a series of 29 questions designed to capture the impact of multiple sclerosis on their life over the past 2 weeks (11). Twenty of the 29 questions assess the physical impact of MS.~The physical impact of MS was compared between pre and post phase using paired t-tests. Each question is answered with points ranging from 1 to 5. Higher score indicates worse outcome. The total MSIS physical score ranges from 20 to 100 points with lower points indicating better impact." (NCT02258217)
Timeframe: baseline visit & follow-up after treatment
| Intervention | score on a scale (Median) |
|---|
| MSIS physical (new relapse) | MSIS physical (after treatment of new relapse) |
|---|
| Single Arm | 58.5 | 56 |
ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)
"Patient history of prior corticosteroid tolerability for the treatment of MS relapses. This will be determined based on patient completion of the ARMS survey at the baseline visit. Also, history of patients from the survey after treatment for the new relapse will be collected.~The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability.~ADL scores were calculated from Part 1 (new relapse), question 3 and Part 2 (after treatment of relapse), question 5 both specifically refer to ADL;~Scale: ADL (Activities of Daily Living) Minimum value: 0 Maximum value: 9 Higher scores indicated better functioning/ improvement." (NCT02258217)
Timeframe: baseline visit & follow-up after treatment
| Intervention | score on a scale (Mean) |
|---|
| ADL (new relapse) | ADL (after treatment of relapse) |
|---|
| Single Arm | 3.1 | 4.9 |
ARMS (Assessing Relapses in Multiple Sclerosis) PCS Scores (Partial Composite Scores)
"Patient history of prior corticosteroid tolerability for the treatment of MS relapses. This will be determined based on patient completion of the ARMS survey at the baseline visit. Also, patients completed the survey after treatment for the new relapse.~The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability.~PCS was computed based on the sum of the ADL and RSH questions. The PCS was computed separately for Part 1 (new relapse) and Part 2 (after relapse treatment) and summarized descriptively; Higher scores indicating better functioning/greater improvement. The PCS scores were on a scale of 0 to 20 units." (NCT02258217)
Timeframe: baseline visit & follow-up after treatment
| Intervention | score on a scale (Mean) |
|---|
| PCS (New relapse) | PCS (after treatment of relapse) |
|---|
| Single Arm | 7.7 | 9.2 |
ARMS (Assessing Relapses in Multiple Sclerosis) RSH Scores (Return to Previous Health)
"Patient history of prior corticosteroid tolerability for the treatment of MS relapses. This will be determined based on patient completion of the ARMS survey at the baseline visit. Also, patients completed the survey after treatment for the new relapse. The ARMS questionnaire (assessing relapses in multiple sclerosis) was developed by a panel of expert MS nurses. Part one consists of 7 questions designed to assess relapse symptoms, impact on activities of daily living, and response to past treatment for MS relapses. Part two consists of 7 questions to evaluate treatment response in terms of relief from symptoms, functioning and tolerability.~Part 1 (new relapse) & Part 2 (after treatment of new relapse), question 6 were used to calculate RSH;~Scale: RSH (Return to previous health) Minimum value: -1 Maximum value: 10 Higher scores indicating a more complete return to previous state of health." (NCT02258217)
Timeframe: baseline visit & follow-up after treatment
| Intervention | score on a scale (Mean) |
|---|
| RSH (new relapse) | RSH (after treatment of new relapse) |
|---|
| Single Arm | 4.6 | 4.4 |
EDSS (Expanded Disability Status Scale) Scores.
"This scaling score is obtained by performing a neurologic exam with specific attention to eight different neurologic functional systems: visual, pyramidal, cerebellar, bowel and bladder, cerebral, brainstem, sensory and other (10). The score is rated from zero (normal neurologic examination) to ten (death due to MS). This is the standard neurologic disability scale used in clinical trials for the evaluation of disability in patients with MS.~These scores were compared between pre and post phase using paired t-tests." (NCT02258217)
Timeframe: baseline and at follow-up
| Intervention | score on a scale (Median) |
|---|
| EDSS score (new relapse) | EDSS score (after treatment of new relapse) |
|---|
| Single Arm | 3.5 | 3.0 |
GASE Scale Questionnaire (Generic Assessment of Side Effects)
"Patients who reported a history of poor corticosteroid tolerability will be placed on Acthar and GASE scale will be given to assess tolerability to Acthar.~We listed the number of times a symptom was reported and was attributable to the ACTHAR treatment" (NCT02258217)
Timeframe: 1 week
| Intervention | Participants (Count of Participants) |
|---|
| Headache | Dry Mouth | Dizziness | Tachycardia, palpitation or arrhythmia | Breathing problems | Abdominal pain | Nausea | Diarrhea | Reduced Appetite | Increased appetite | Difficulties with urination | Skin rash or itching | Tendency to develop bruises | Sweating | Hot flashes | Fatigue, loss of energy | Insomnia, sleeping problems | Nightmares or abnormal dreams | Back pain | Agitation | Irritability | Depressed Mood | Anxiety, fearfulness | Further symptoms |
|---|
| Single Arm | 3 | 1 | 2 | 1 | 1 | 4 | 4 | 4 | 1 | 4 | 2 | 1 | 1 | 1 | 1 | 2 | 8 | 2 | 1 | 6 | 6 | 3 | 1 | 8 |
Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
A self and informant rating measure of perceived cognitive problems. Minimum of 0, maximum of 60. Higher scores indicates greater self-reported neuropsychological impairment. The difference in total score on the MSNQ from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90
| Intervention | Total Score (Mean) |
|---|
| Cognitively Relapsing Patients | 34.5 |
| Stable Multiple Sclerosis Patients | 20.0 |
Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)
A measure of auditory/verbal episodic memory. Minimum of 0, maximum of 80. Higher score indicates better performance. The difference in total learning score on the CVLT-II from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90
| Intervention | Total Learning Score (Mean) |
|---|
| Cognitively Relapsing Patients | 46.6 |
| Stable Multiple Sclerosis Patients | 51.2 |
Change From Baseline on the Expanded Disability Status Scale (EDSS).
A clinician assigned measure of disability specific to MS. Minimum of 0 (no disability), maximum of 10 (death due to MS). Higher scores indicate greater disability. The difference in total score on the EDSS from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90
| Intervention | Total Score (Median) |
|---|
| Cognitively Relapsing Patients | 3.0 |
| Stable Multiple Sclerosis Patients | 2.0 |
Change From Baseline on the Fatigue Severity Scale (FSS)
A self-report measure of fatigue. 1 (no fatigue) to 9 (severe fatigue). The difference in total score on FSS from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90
| Intervention | Total Score (Mean) |
|---|
| Cognitively Relapsing Patients | 5.4 |
| Stable Multiple Sclerosis Patients | 3.8 |
Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)
A measure of auditory processing speed and working memory. Minimum value of 0, maximum value of 60. Higher score indicates better performance. The difference in total correct on the PASAT from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90
| Intervention | Total Correct (Mean) |
|---|
| Cognitively Relapsing Patients | 40.1 |
| Stable Multiple Sclerosis Patients | 47.0 |
Change From Baseline on the Symbol Digit Modalities Test (SDMT)
A measure of visual processing speed and working memory. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance. The difference in total correct responses on the SDMT from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90
| Intervention | Total Correct (Mean) |
|---|
| Cognitively Relapsing Patients | 44.6 |
| Stable Multiple Sclerosis Patients | 58.5 |
Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)
A self-report, multiple choice inventory of depression. Minimum of 0, maximum of 21. Higher score indicates higher levels of depression. The difference in total score on the BDI-FS from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90
| Intervention | Total Score (Mean) |
|---|
| Cognitively Relapsing Patients | 5.0 |
| Stable Multiple Sclerosis Patients | 1.6 |
Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)
A measure of visual/spatial memory. Minimum of 0, maximum of 36. Higher score indicates better performance. The difference in total learning score on the BVMT-R from Day 0 to Day 90 were analyzed to address change in this outcome. (NCT02290444)
Timeframe: Day 0 and Day 90
| Intervention | Total Learning Score (Mean) |
|---|
| Cognitively Relapsing Patients | 22.0 |
| Stable Multiple Sclerosis Patients | 22.5 |
Quality of Life at 28 Weeks
Patient-reported quality of life as measured by the 36-Item Short Form Health Survey (SF-36) at 28 weeks. The SF-36 is a 36-item, patient-reported survey of patient mental and physical health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. (NCT02315872)
Timeframe: 28 weeks
,
| Intervention | score on a scale (Median) |
|---|
| SF-36 Mental | SF-36 Physical |
|---|
| ACTH | 39.50 | 37.50 |
| Placebo | 49.00 | 45.00 |
Depression at 28 Weeks
Patient-reported depression as measured by the Beck Depression Inventory-II (BDI-II) at 28 weeks. The BDI-II is a 21-item self-report multiple-choice inventory used as an indicator of the severity of depression. A higher score indicates a greater severity of depression. (NCT02315872)
Timeframe: 28 weeks
| Intervention | score on a scale (Median) |
|---|
| ACTH | 16.50 |
| Placebo | 40.00 |
Sleepiness at 28 Weeks
Patient-reported daytime sleepiness as measure by the Epworth Sleepiness Scale (ESS) at 28 weeks. The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'. (NCT02315872)
Timeframe: 28 weeks
| Intervention | score on a scale (Median) |
|---|
| ACTH | 11.00 |
| Placebo | 7.00 |
Fatigue at 28 Weeks
Patient-reported levels of fatigue as measured by score on the Modified Fatigue Impact Scale (MFIS) and the Fatigue Severity Scale (FSS) at 28 weeks. The full-length MFIS consists of 21 items. A higher score on the MFIS indicates a greater impact of fatigue on a patient's activities. The FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Higher scores on each scale indicate a greater severity of fatigue. (NCT02315872)
Timeframe: 28 weeks
,
| Intervention | score on a scale (Median) |
|---|
| MFIS | FSS |
|---|
| ACTH | 56.50 | 55.00 |
| Placebo | 29.00 | 40.00 |
Change in T2 Lesion Volume
The change in T2 lesion volume between baseline and one year MRI's will be calculated and compared between treatment groups. (NCT02446886)
Timeframe: 12 months
| Intervention | millimeters cubed (Mean) |
|---|
| One Time Treatment | 683.59 |
| Monthly Treatments | 1092.08 |
Longitudinal Assessment of MWF
"Outcome measure: Longitudinal assessment of MWF (every 3 months) to determine the dynamics of myelin change over 12 months.~Method to assess lesion MWF: FAST-T2 is a multi-compartment T2 relaxometry MRI technique wherein the contribution of water associated with myelin and other tissue compartments is differentiated using T2 decay curve analysis. The relative contribution of the myelin water with respect to total water is represented as MWF. A higher MWF within a lesion reflects higher myelin content within that lesion.~For this analysis, MWF maps were reconstructed from FAST-T2 MRI data by using a multi-voxel nonlinear least-squares data-fitting algorithm with spatial smoothness constraints. MWF was calculated as the ratio of the myelin water signal to the total water signal within a voxel. Lesion MWF is an average of the voxels present within an individual lesion." (NCT02446886)
Timeframe: 12 months
| Intervention | myelin water fraction (Mean) |
|---|
| One Time Treatment | 1.7 |
| Monthly Treatments | -.2 |
Physical Disability as Measured by EDSS
"Expanded Disability Status Scale (EDSS)~0 Normal neurological exam, no disability in any FS 1.0 No disability, minimal signs in one FS 1.5 No disability, minimal signs in more than one FS 2.0 Minimal disability in one FS 2.5 Mild disability in one FS or minimal disability in two FS 3.0 Moderate disability in one FS, or mild disability in three or four FS. No impairment to walking 3.5 Moderate disability in one FS and more than minimal disability in several others. No impairment to walking 4.0 Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m 4.5 Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m~10.0 Death due to MS~A higher score means a worse outcome." (NCT02446886)
Timeframe: 12 months
| Intervention | score on a scale (Mean) |
|---|
| One Time Treatment | .5 |
| Monthly Treatments | 1.1 |
Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months
"Primary outcome: The absolute change in lesion MWF (over our test-retest variability) between baseline and one year MRI's will be calculated and compared between treatment groups.~Method to assess lesion MWF: FAST-T2 is a multi-compartment T2 relaxometry MRI technique wherein the contribution of water associated with myelin and other tissue compartments is differentiated using T2 decay curve analysis. The relative contribution of the myelin water with respect to total water is represented as MWF. A higher MWF within a lesion reflects higher myelin content within that lesion.~For this analysis, MWF maps were reconstructed from FAST-T2 MRI data by using a multi-voxel nonlinear least-squares data-fitting algorithm with spatial smoothness constraints. MWF was calculated as the ratio of the myelin water signal to the total water signal within a voxel. Lesion MWF is an average of the voxels present within an individual lesion." (NCT02446886)
Timeframe: Baseline, 12 months
| Intervention | myelin water fraction (Mean) |
|---|
| One Time Treatment | 1.7 |
| Monthly Treatments | -0.20 |
Safety (Serious Adverse Events)
"Participants will be monitored for Serious Adverse Events, as follows (as described in ClinicalTrials.gov) Death, Life-threatening events, Hospitalization (initial or prolonged), Disability and events that requires intervention to prevent permanent impairment or damage.~Other (non serious) events which were anticipated or unanticipated (as described in ClinicaTrials.gov) will be monitored.~ASSESSMENT: The subjects will be assessed at regular intervals through a questionnaire for Acthar related events, physician evaluation at clinical visits, and self reporting." (NCT02546492)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Serious Adverse Events (SAE) | 2 |
Efficacy Outcome
composite of graft loss, death, decrease in eGFR>10%, and increase in proteinuria (NCT02546492)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Composite outcome | Death | Decreased GFR>10% | Increased proteinuria |
|---|
| Efficacy Outcomes | 3 | 1 | 1 | 1 |
Number of Participants With Adverse Events
"Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with:~death for any reason (all cause mortality)~treatment emergent serious adverse events (TESAEs)~any non-serious treatment emergent adverse events (TEAEs)" (NCT02633046)
Timeframe: within 56 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Deaths | Serious TEAEs | Non-serious TEAEs |
|---|
| Acthar Gel | 0 | 11 | 60 |
Proportion of Patients Experiencing a Tapering of Ocular/Oral Steroids by at Least 50%
(NCT02725177)
Timeframe: Measured at 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| H.P. Achtar Gel 80 U | 2 |
Proportion of Patients With a Clinically Significant Reduction-cystoid Macular Edema
(NCT02725177)
Timeframe: Measured at 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| H.P. Achtar Gel 80 U | 1 |
Percentage of Patients With Clinically Significant Improvement in Visual Acuity
The primary outcome was percentage of patients meeting at least one of the following variables 1) improved visual acuity, 2) resolution of intraocular inflammation, 3) ability to taper ocular or oral steroids by at least 50% or 4) reduction of cystoid macular edema, with no worsening of any single one and no need for additional sarcoidosis therapies at 24 weeks . (NCT02725177)
Timeframe: Measured at 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| H.P. Achtar Gel 80 U | 3 |
Percentage of Patients With Clinically Significant Improvement in the Resolution-intraocular Inflammation
(NCT02725177)
Timeframe: Measured at 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| H.P. Achtar Gel 80 U | 2 |
Number of Participants With Clinically Significant Improvement of Macular Edema
Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns (NCT02764697)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Decrease in Central Foveal Thickness <300 | Decrease in central Fovea > 300 Microns |
|---|
| H.P. Acthar Subcutaneous Gel Injection | 0 | 5 |
Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination
standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more cellularity. (NCT02769702)
Timeframe: Baseline and 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 12 Weeks |
|---|
| Acthar 80 IU | 0.5 | 1.25 |
Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation
standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more protein. (NCT02769702)
Timeframe: Baseline and 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 12 Weeks |
|---|
| Acthar 80 IU | NA | 1.0 |
Part 1: Patient-Reported General Health by Visit
"Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.~A lower score indicates better general health." (NCT02919761)
Timeframe: Baseline to Week 12
| Intervention | mm (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 | at Week 12 |
|---|
| Part 1: All Participants Enrolled | 59.8 | 45.1 | 37.8 | 27.0 |
Part 1: Tender Joint Count by Visit
"The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate" (NCT02919761)
Timeframe: Baseline to Week 12
| Intervention | Count of Tender Joints (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 | at Week 12 |
|---|
| Part 1: All Participants Enrolled | 14.7 | 7.7 | 5.7 | 3.9 |
Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit
"The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.~The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).~The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.~The ESR is a common test for inflammation and used to derive the DAS28.~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate" (NCT02919761)
Timeframe: Baseline to Week 12
| Intervention | mm/hr (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 | at Week 12 |
|---|
| Part 1: All Participants Enrolled | 43.6 | 35.4 | 30.6 | 24.0 |
Part 1: Number of Participants With Low Disease Activity (LDA) by Visit
LDA is defined as DAS28 <3.2. (NCT02919761)
Timeframe: Baseline to Week 12
| Intervention | Participants (Count of Participants) |
|---|
| at Baseline | at Week 4 | at Week 8 | at Week 12 |
|---|
| Part 1: All Participants Enrolled | 0 | 17 | 37 | 163 |
Part 2: Patient-Reported General Health by Visit
"Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.~A lower score indicates better general health." (NCT02919761)
Timeframe: Baseline, Week 12 to Week 24
,
| Intervention | mm (Mean) |
|---|
| at Baseline | at Week 12 | at Week 16 | at Week 20 | at Week 24 |
|---|
| Part 2: Acthar Gel | 13.5 | 18.8 | 19.6 | 17.9 | 21.3 |
| Part 2: Placebo | 13.5 | 15.4 | 17.2 | 18.5 | 21.4 |
Part 2: Number of Participants Who Maintained Low Disease Activity by Visit
Low disease activity is defined as DAS28 <3.2. (NCT02919761)
Timeframe: Week 12 to Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| at Week 12 | at Week 16 | at Week 20 | at Week 24 |
|---|
| Part 2: Acthar Gel | 75 | 53 | 48 | 32 |
| Part 2: Placebo | 77 | 58 | 61 | 47 |
Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit
"The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.~The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).~The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.~The ESR is a common test for inflammation and used to derive the DAS28.~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate" (NCT02919761)
Timeframe: Baseline, Week 12 to Week 24
,
| Intervention | mm/hr (Mean) |
|---|
| at Baseline | at Week 12 | at Week 16 | at Week 20 | at Week 24 |
|---|
| Part 2: Acthar Gel | 40.3 | 15.8 | 17.7 | 17.5 | 23.1 |
| Part 2: Placebo | 42.2 | 15.2 | 19.6 | 22.0 | 25.1 |
Part 1: Swollen Joint Count by Visit
"The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate" (NCT02919761)
Timeframe: Baseline to Week 12
| Intervention | Count of swollen joints (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 | at Week 12 |
|---|
| Part 1: All Participants Enrolled | 10.9 | 5.6 | 4.0 | 2.8 |
Part 1: Physician's Global Assessment of Disease Activities by Visit
The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement. (NCT02919761)
Timeframe: Baseline to Week 12
| Intervention | mm (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 | at Week 12 |
|---|
| Part 1: All Participants Enrolled | 64.3 | 36.1 | 29.0 | 21.0 |
Part 1: Patient's Global Assessment of Pain by Visit
Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain. (NCT02919761)
Timeframe: Baseline to Week 12
| Intervention | mm (Mean) |
|---|
| at Baseline | at Week 4 | at Week 8 | at Week 12 |
|---|
| Part 1: All Participants Enrolled | 64.9 | 44.1 | 37.3 | 27.5 |
Part 2: Tender Joint Count by Visit
"The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate" (NCT02919761)
Timeframe: Baseline, Week 12 to Week 24
,
| Intervention | Count of Tender Joints (Mean) |
|---|
| at Baseline | at Week 12 | at Week 16 | at Week 20 | at Week 24 |
|---|
| Part 2: Acthar Gel | 13.5 | 1.4 | 1.6 | 1.5 | 2.4 |
| Part 2: Placebo | 13.5 | 1.5 | 2.6 | 2.7 | 3.1 |
Part 2: Swollen Joint Count by Visit During Part 2
"The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28)~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate" (NCT02919761)
Timeframe: Baseline, Week 12 to Week 24
,
| Intervention | Count of swollen joints (Mean) |
|---|
| at Baseline | at Week 12 | at Week 16 | at Week 20 | at Week 24 |
|---|
| Part 2: Acthar Gel | 9.7 | 0.9 | 1.1 | 0.9 | 1.5 |
| Part 2: Placebo | 10.1 | 0.9 | 1.7 | 1.9 | 2.3 |
Part 2: Physician's Global Assessment of Disease Activities by Visit
The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement. (NCT02919761)
Timeframe: Week 12 to Week 24
,
| Intervention | mm (Mean) |
|---|
| at Week 12 | at Week 16 | at Week 20 | at Week 24 |
|---|
| Part 2: Acthar Gel | 12.9 | 13.3 | 12.4 | 15.2 |
| Part 2: Placebo | 11.5 | 15.5 | 15.9 | 17.8 |
Part 2: Patient's Global Assessment of Pain by Visit
Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain. (NCT02919761)
Timeframe: Baseline, Week 12 to Week 24
,
| Intervention | mm (Mean) |
|---|
| at Baseline | at Week 12 | at Week 16 | at Week 20 | at Week 24 |
|---|
| Part 2: Acthar Gel | 65.7 | 18.9 | 22.1 | 19.8 | 21.8 |
| Part 2: Placebo | 62.8 | 17.0 | 21.6 | 20.0 | 22.1 |
Time of Application
Time of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix (NCT02941640)
Timeframe: 120 min
| Intervention | seconds (Mean) |
|---|
| Laparoscopic Appendectomy. Endoloop. | 195.50 |
| Laparoscopic Appendectomy. Stapler | 19.87 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | 63.90 |
| Laparoscopic Appendectomy. DS Clip | 63.77 |
Operative Time
Time of operative procedure (NCT02941640)
Timeframe: 120 min.
| Intervention | minutes (Mean) |
|---|
| Laparoscopic Appendectomy. Endoloop. | 46.0 |
| Laparoscopic Appendectomy. Stapler | 39.37 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | 42.83 |
| Laparoscopic Appendectomy. DS Clip | 47.47 |
Intra-perative Complications
Complications that appear during operative procedure (NCT02941640)
Timeframe: 120 min.
| Intervention | Participants (Count of Participants) |
|---|
| Laparoscopic Appendectomy. Endoloop. | 0 |
| Laparoscopic Appendectomy. Stapler | 0 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | 0 |
| Laparoscopic Appendectomy. DS Clip | 0 |
Hospital Stay
Length of hospitalization (NCT02941640)
Timeframe: 30 days
| Intervention | days (Median) |
|---|
| Laparoscopic Appendectomy. Endoloop. | 2.17 |
| Laparoscopic Appendectomy. Stapler | 2.20 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | 2.23 |
| Laparoscopic Appendectomy. DS Clip | 2.37 |
Postoperative Complications
Complications that appear after operative procedure (NCT02941640)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Laparoscopic Appendectomy. Endoloop. | 0 |
| Laparoscopic Appendectomy. Stapler | 0 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | 0 |
| Laparoscopic Appendectomy. DS Clip | 0 |
Overall Morbidity
Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day. (NCT02941640)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Laparoscopic Appendectomy. Endoloop. | 0 |
| Laparoscopic Appendectomy. Stapler | 0 |
| Laparoscopic Appendectomy. Hem-o-lok Clip | 0 |
| Laparoscopic Appendectomy. DS Clip | 0 |
Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)
The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement. (NCT02953821)
Timeframe: Week 16, Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| Week 16 | Week 24 |
|---|
| Acthar Gel | 41 | 44 |
| Placebo Gel | 40 | 46 |
Mean Number of Swollen or Tender Joints on the 28-Joint Count
The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week. (NCT02953821)
Timeframe: at Baseline and at Weeks 4, 8, 12 and 16
,
| Intervention | Joints (Mean) |
|---|
| Baseline | Week 4 | Week 8 | Week 12 | Week 16 |
|---|
| Acthar Gel | 8.2 | 4.2 | 2.9 | 2.3 | 1.9 |
| Placebo Gel | 7.2 | 4.9 | 3.8 | 2.9 | 2.8 |
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
The CLASI total activity score reflects ongoing inflammation that can be treated, with points given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Mild, moderate, and severe disease correspond with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity, lower scores indicate improvement. (NCT02953821)
Timeframe: at Baseline and Weeks 4, 8, and 16
,
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Week 4 | Week 8 | Week 12 | Week 16 |
|---|
| Acthar Gel | 7.9 | 5.6 | 5.0 | 4.0 | 3.4 |
| Placebo Gel | 7.1 | 5.8 | 5.0 | 4.5 | 3.8 |
British Isles Lupus Assessment Group 2004 (BILAG 2004)
"BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new.~The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity." (NCT02953821)
Timeframe: Baseline, Week 16, Week 24
,
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Week 16 | Week 24 |
|---|
| Acthar Gel | 18.0 | 7.7 | 6.9 |
| Placebo Gel | 18.2 | 9.7 | 8.0 |
Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16
Among some adults, having a period of SLE symptoms-called flares-may happen every so often, sometimes even years apart, and go away at other times-called remission. The SFI categorizes SLE flares as mild, moderate or severe. (NCT02953821)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|
| Placebo Gel | 3 |
| Acthar Gel | 0 |
Physician's Global Assessment (PGA)
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement. (NCT02953821)
Timeframe: Baseline, Week 16, Week 24
,
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Week 16 | Week 24 |
|---|
| Acthar Gel | 60.6 | 30.2 | 25.5 |
| Placebo Gel | 58.8 | 33.2 | 26.9 |
Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24
(NCT02953821)
Timeframe: Week 20, Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| Week 20 | Week 24 |
|---|
| Acthar Gel | 3 | 4 |
| Placebo Gel | 5 | 6 |
Number of Participants With Complete or Partial Remission
Complete (proteinuria reduction <500mg/24h) or partial (urinary protein excretion (P/C) <3.0 g/g (with at least 50% reduction versus baseline) in at least two consecutive visits) remission. (NCT03025828)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| complete remission | partial remission |
|---|
| Acthar | 0 | 4 |
Estimated Glomerular Filtration Rate (GFR)
GFR measures kidney function. (NCT03025828)
Timeframe: baseline and 12 months
| Intervention | mL/min (Median) |
|---|
| baseline | 12 months |
|---|
| Acthar | 90.5 | 80.5 |
Change in Serum Albumin
Change in serum albumin from baseline (NCT03025828)
Timeframe: baseline 6 months, 12 months
| Intervention | g/dl (Median) |
|---|
| baseline and 6 months | baseline and 12 months |
|---|
| Acthar | 3.0 | 3.65 |
Change in Proteinuria
Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio (NCT03025828)
Timeframe: baseline and 12 months
| Intervention | ratio (Median) |
|---|
| baseline | 12 months |
|---|
| Acthar | 4.56 | 1.36 |
Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio
blood levels - one single cell subset identified by different markers (NCT03025828)
Timeframe: baseline and 12 months
| Intervention | ratio (Median) |
|---|
| Baseline | 12 Months |
|---|
| Acthar | 0.04 | 0.12 |
Treatment Period: Spirometry (%)
Spirometry (meaning the measuring of breath) is the most common of the lung function tests. It measures how much air can be inhaled [Forced Vital Capacity (FVC)] and exhaled [(Forced Expiratory Volume in one second (FEV1)]. (NCT03068754)
Timeframe: Baseline, Week 36
,
| Intervention | liters (Mean) |
|---|
| FVC at Baseline | FVC at Week 36 | FEV1 at Baseline | FEV1 at Week 36 |
|---|
| Arm A: RTP Acthar Gel | 85.0 | 61.4 | 79.3 | 59.1 |
| Arm B: RTP Placebo | 82.1 | 63.8 | 77.8 | 54.3 |
Treatment Period: Scores on a Scale for Telephone-administered Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
"The ALSFRS-R is a validated questionnaire-based scale used extensively as a primary outcome measure in ALS clinical trials and is considered a predictor of survival.~ALSFRS-R is a 12-item scale that measures 4 domains relevant for ALS (gross motor, fine motor, bulbar and respiratory)~A trained, independent rater calls each participant (or the caregiver) to administer the questionnaire. The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function." (NCT03068754)
Timeframe: Baseline, Week 36
,
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Week 36 |
|---|
| Arm A: RTP Acthar Gel | 34.7 | 26.4 |
| Arm B: RTP Placebo | 34.3 | 30.8 |
Treatment Period: Scores on a Scale for Investigator-administered ALSFRS-R
"The ALSFRS-R is a 12-item scale evaluating 4 domains relevant to ALS (gross motor, fine motor, bulbar and respiratory).~The trained investigator (or designee) administers the ALSFRS-R questionnaire in person with the participant (or caregiver). The 12 functions are rated on a scale from 0 to 4, with a highest possible (summed) score of 48. Higher scores represent better function." (NCT03068754)
Timeframe: Baseline, Week 36
,
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Week 36 |
|---|
| Arm A: RTP Acthar Gel | 35.8 | 28.0 |
| Arm B: RTP Placebo | 35.4 | 30.9 |
Number of Participants Experiencing an Adverse Event During the Treatment Period
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study Clinically significant changes in safety measures are recorded as adverse events. (NCT03068754)
Timeframe: by the end of the treatment period (within 36 Weeks)
,
| Intervention | Participants (Count of Participants) |
|---|
| Serious Treatment Emergent Adverse Events | Non-serious Treatment-Emergent Adverse Events | Death |
|---|
| Arm A: RTP Acthar Gel | 13 | 74 | 2 |
| Arm B: RTP Placebo | 6 | 40 | 3 |
Number of Participants Experiencing an Adverse Event by the End of the Trial in the OLE Period
Serious adverse events, non-serious treatment-emergent adverse events, and all-cause mortality are collected until the participant no longer participates in the study (estimated about 1 year for participants leaving after the treatment period, and two years for participants who participate also in the open label extension). Clinically significant changes in safety measures are recorded as adverse events. (NCT03068754)
Timeframe: by the time of database lock (within 84 weeks)
,
| Intervention | Participants (Count of Participants) |
|---|
| Serious Treatment Emergent Adverse Events | Non-serious Treatment-Emergent Adverse Events |
|---|
| Arm C: OLE Acthar Gel-Acthar Gel | 4 | 20 |
| Arm D: OLE Placebo-Acthar Gel | 2 | 7 |
Extension Period: Scores on a Scale for Investigator-administered ALSFRS-R
"The ALSFRS-R is a 12-item scale evaluating 4 domains relevant to ALS (gross motor, fine motor, bulbar and respiratory).~The trained investigator (or designee) administers the ALSFRS-R questionnaire in person with the participant (or caregiver). The 12 functions are rated on a scale from 0 to 4, with a highest possible score of 48. Higher scores represent better function." (NCT03068754)
Timeframe: Baseline, Week 84
,
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Week 84 |
|---|
| Arm C: OLE Acthar Gel-Acthar Gel | 36.8 | 27.4 |
| Arm D: OLE Placebo-Acthar Gel | 39.6 | 21.5 |
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received. (NCT03126760)
Timeframe: Baseline, Day 42
,
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Day 42 |
|---|
| Acthar Gel | 3.86 | 2.92 |
| Placebo | 3.85 | 3.62 |
Intraocular Pressure
goldmann tonometry used by qualified technician with fluorescein staining (NCT03287635)
Timeframe: 12 weeks measuring change from baseline to final
| Intervention | mm Hg (Mean) |
|---|
| Acthar Gel 80 U/ml | -1.65 |
Dry Eye Comfort Questionnaire, SANDE
"Subjects will be asked to subjectively rate their eye dryness at Visit 1,2 and 3. Subjects will be instructed to rate eye dryness using the scale below. The total length of the line from no dryness to maximal dryness is 100 mm. The length of the line between the no dryness starting point and the first point at which the subject mark crosses the line will be measured in mm. This assessment is a general assessment of the change of both eyes of dryness measure from baseline to final study visit. The measure of discomfort was for the instantaneous measurement at the time of the specific visit." (NCT03287635)
Timeframe: 12 weeks total. Measure is change on SANDE scale (0 is no dryness and 100mm is maximal dryness) from baseline to final value. Higher values reflect greater amounts of subjective dryness.
| Intervention | scores on a scale (Mean) |
|---|
| Acthar Gel 80 U/ml | 44.77 |
1. Conjunctival Staining With Lissamine Green
Change in Conjunctival staining with lissamine green. (NCT03287635)
Timeframe: 12 weeks total. Measure is change from baseline to final,
| Intervention | staining spots on conjunctiva (Mean) |
|---|
| Acthar Gel 80 U/ml | -173.33 |
OLE: Number of Participants in Each Category of Assessment Based on the KSQ (General Health), a Quality of Life Parameter at Week 48
"King's sarcoidosis questionnaire (KSQ) (General Health) is a 28-item questionnaire for participants to indicate the status of their sarcoidosis and treatment. Each item was answered on a 7-point scale where 1 means the participant experiences the symptom all the time and 7 means the participant does not experience the symptom at all. Higher scores indicate improvement, and a change of 4 points is considered clinically meaningful. The score on the scale was evaluated to determine if the condition is:~Improved (+1) based on a change of ≥ 4 points~Unchanged (0) based on a change of >- 4 to < 4 points~Worse (-1) based on a change of ≤ -4 points~An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 48
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 8 | 2 | 6 | 6 |
| Placebo in DBT Then Acthar Gel in OLE | 8 | 5 | 9 | 3 |
OLE: Number of Participants in Each Category of Assessment Based on the DLCO, a Pulmonary Function Test Parameter at Week 48
"The diffusing capacity of the lungs for carbon monoxide (DLCO) measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in the blood. Participants are asked to fully inhale a low concentration of carbon monoxide and an inert tracer gas. Based on the absolute change of percent predicted, DLCO was evaluated to determine if the condition is:~Improved (+1) [≥ 5% absolute change]~Unchanged (0) [>- 5% to < 5% absolute change],~Worse (-1) [≤ -5% absolute change]~An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 48
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 9 | 3 | 4 | 6 |
| Placebo in DBT Then Acthar Gel in OLE | 6 | 6 | 8 | 5 |
OLE: Number of Participants in Each Category of Assessment Based on HRCT at Week 48
"High-resolution computer tomography (HRCT) is a type of computed tomography (CT) with specific techniques to enhance image resolution. It is used in the diagnosis of various health problems, most commonly for lung disease. These images show cross sections (slices) through the lungs. HRCT imaging was evaluated by the investigator/radiologist and the central reader to determine if the condition is improved (+1), unchanged (0), or worse (-1). An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 48
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 1 | 13 | 1 | 7 |
| Placebo in DBT Then Acthar Gel in OLE | 6 | 13 | 2 | 4 |
OLE: Number of Participants in Each Category of Assessment Based on FVC, a Pulmonary Function Test Parameter at Week 48
"Forced vital capacity (FVC) is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. Based on the absolute change of percent predicted, FVC was evaluated to determine if the condition is:~Improved (+1) [≥ 5% absolute change]~Unchanged (0) [>- 5% to < 5% absolute change], or~Worse (-1) [≤ -5% absolute change]~An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 48
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 2 | 13 | 1 | 6 |
| Placebo in DBT Then Acthar Gel in OLE | 6 | 11 | 3 | 5 |
OLE: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 48
"Corticosteroids are first line treatment for sarcoidosis. Concerns of corticosteroid toxicity led to efforts to taper dose sooner. Participants were clinically evaluated at each visit by investigator and categorized by their condition; dose was tapered using algorithm to take them off prednisone using incremental doses of 40,30,20,10,7.5,5,2.5,0 mg, as explained with each category below.~Improved: When condition improved, reduce dose by 1 level~Unchanged:~When stable condition without toxicity: At first stable visit they continue same dose; at second stable visit, reduce dose by 1 level~When stable condition with toxicity: toxicity is treated; reduce dose by 1 level~Deteriorate: When worsening condition, increase dose by 1 or 2 levels but not >40mg/day~Dose tapering was done based on the participant's clinical condition.~Category Missing Assessment indicates participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 48
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 15 | 5 | 0 | 2 |
| Placebo in DBT Then Acthar Gel in OLE | 19 | 5 | 0 | 1 |
DBT: Number of Participants in Each Category of Assessment Based on the King's Sarcoidosis Questionnaire (KSQ) (General Health), a Quality of Life Parameter at Week 24
"King's sarcoidosis questionnaire (KSQ) (General Health) is a 28-item questionnaire for participants to indicate the status of their sarcoidosis and treatment. Each item was answered on a 7-point scale where 1 means the participant experiences the symptom all the time and 7 means the participant does not experience the symptom at all. Higher scores indicate improvement, and a change of 4 points is considered clinically meaningful. The score on the scale was evaluated to determine if the condition is:~Improved (+1) based on a change of ≥ 4 points~Unchanged (0) based on a change of >- 4 to < 4 points~Worse (-1) based on a change of ≤ -4 points~An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 11 | 3 | 10 | 3 |
| Placebo in DBT Then Acthar Gel in OLE | 7 | 8 | 9 | 4 |
DBT: Number of Participants in Each Category of Assessment Based on the Fatigue Assessment Score (FAS), a Quality of Life Parameter at Week 24
"The fatigue assessment score (FAS) is a 10-item checklist for participants to indicate the level of their fatigue. Each item was answered on a 5-point scale where 1 means the participant does not experience the symptom all and 5 means the participant experiences the symptom all the time. Lower scores indicate improvement (less fatigue) and a change of 4 points is considered clinically meaningful. The score on the scale was evaluated to determine if the condition is:~Improved (+1) based on a change of ≤ -4 points~Unchanged (0) based on a change of >- 4 to < 4 points~Worse (-1) based on a change of ≥ 4 points~An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 6 | 12 | 6 | 3 |
| Placebo in DBT Then Acthar Gel in OLE | 6 | 11 | 7 | 4 |
DBT: Number of Participants in Each Category of Assessment Based on the Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), a Pulmonary Function Test Parameter at Week 24
"The diffusing capacity of the lungs for carbon monoxide (DLCO) measures the ability of the lungs to transfer gas from inhaled air to the red blood cells in the blood. Participants are asked to fully inhale a low concentration of carbon monoxide and an inert tracer gas. Based on the absolute change of percent predicted, DLCO was evaluated to determine if the condition is:~Improved (+1) [≥ 5% absolute change]~Unchanged (0) [>- 5% to < 5% absolute change],~Worse (-1) [≤ -5% absolute change]~An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 5 | 11 | 7 | 4 |
| Placebo in DBT Then Acthar Gel in OLE | 4 | 11 | 7 | 6 |
DBT: Number of Participants in Each Category of Assessment Based on High Resolution Computer Tomography (HRCT) at Week 24
"High-resolution computer tomography (HRCT) is a type of computed tomography (CT) with specific techniques to enhance image resolution. It is used in the diagnosis of various health problems, most commonly for lung disease. These images show cross sections (slices) through the lungs. HRCT imaging was evaluated by the investigator/radiologist and the central reader to determine if the condition is improved (+1), unchanged (0), or worse (-1). An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 2 | 22 | 0 | 3 |
| Placebo in DBT Then Acthar Gel in OLE | 1 | 18 | 4 | 5 |
DBT: Number of Participants in Each Category of Assessment Based on Forced Vital Capacity (FVC), a Pulmonary Function Test Parameter at Week 24
"Forced vital capacity (FVC) is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function. Based on the absolute change of percent predicted, FVC was evaluated to determine if the condition is:~Improved (+1) [≥ 5% absolute change]~Unchanged (0) [>- 5% to < 5% absolute change], or~Worse (-1) [≤ -5% absolute change]~An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 10 | 12 | 1 | 4 |
| Placebo in DBT Then Acthar Gel in OLE | 7 | 12 | 3 | 6 |
DBT: Number of Participants in Each Category of Assessment Based on Corticosteroid Taper Score in Participants Receiving Each Dose of Prednisone at Week 24
"Corticosteroids are first line treatment for sarcoidosis. Concerns of corticosteroid toxicity led to efforts to taper dose sooner. Participants were clinically evaluated at each visit by investigator and categorized by their condition; dose was tapered using algorithm to take them off prednisone using incremental doses of 40,30,20,10,7.5,5,2.5,0 mg, as explained with each category below.~Improved: When condition improved, reduce dose by 1 level~Unchanged:~When stable condition without toxicity: At first stable visit they continue same dose; at second stable visit, reduce dose by 1 level~When stable condition with toxicity: toxicity is treated; reduce dose by 1 level~Deteriorate: When worsening condition, increase dose by 1 or 2 levels but not >40mg/day~Dose tapering was done based on the participant's clinical condition.~Category Missing Assessment indicates participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 24
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 17 | 8 | 0 | 2 |
| Placebo in DBT Then Acthar Gel in OLE | 21 | 4 | 0 | 3 |
OLE: Number of Participants in Each Category of Assessment Based on FAS, a Quality of Life Parameter at Week 48
"The fatigue assessment score (FAS) is a 10-item checklist for participants to indicate the level of their fatigue. Each item was answered on a 5-point scale where 1 means the participant does not experience the symptom all and 5 means the participant experiences the symptom all the time. Lower scores indicate improvement (less fatigue) and a change of 4 points is considered clinically meaningful. The score on the scale was evaluated to determine if the condition is:~Improved (+1) based on a change of ≤ -4 points~Unchanged (0) based on a change of >- 4 to < 4 points~Worse (-1) based on a change of ≥ 4 points~An additional category Missing Assessment indicates the participants who had a missing assessment for this outcome measure." (NCT03320070)
Timeframe: Week 48
,
| Intervention | Participants (Count of Participants) |
|---|
| Improved | Unchanged | Deteriorate | Missing Assessment |
|---|
| Acthar Gel in DBT Then Acthar Gel in OLE | 7 | 5 | 4 | 6 |
| Placebo in DBT Then Acthar Gel in OLE | 4 | 13 | 5 | 3 |
Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]
A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms. (NCT04169061)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|
| All Participants | 17 |
Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
(NCT04398537)
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)
| Intervention | Participants (Count of Participants) |
|---|
| 5mm Retraction of Clip Deployment Apparatus | 46 |
| no Retraction of Clip Deployment Apparatus | 44 |
Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
This number of participants will be counted if their clip migrated more than 10mm from the biopsy site. (NCT04398537)
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)
| Intervention | Participants (Count of Participants) |
|---|
| 5mm Retraction of Clip Deployment Apparatus | 46 |
| no Retraction of Clip Deployment Apparatus | 44 |
Average Distance of Clip Migration for the Arm That Received 5mm Retraction.
(NCT04398537)
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)
| Intervention | mm (Mean) |
|---|
| 5mm Retraction of Clip Deployment Apparatus | 12.1 |
Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.
(NCT04398537)
Timeframe: baseline through 1 hour (post biopsy mammogram/procedure)
| Intervention | mm (Mean) |
|---|
| no Retraction of Clip Deployment Apparatus | 9.8 |