prednisone and ANCA-Associated Vasculitides

prednisone has been researched along with ANCA-Associated Vasculitides in 39 studies

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.

Research

Studies (39)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Number of Subjects Experiencing a Relapse After Previously Achieving BVAS=0 During the Study

"BVAS=Birmingham Vasculitis Activity Score;~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

Number of Subjects With Clinically Significant ECG Changes From Baseline

"Clinical significance was assessed by the individual reading of the ECGs~ECG=Electrocardiogram" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

Percentage of Participants With BVAS of 0 at Week 4, Regardless of Whether the Subjects Received Glucocorticoids During This Period of Time and Based on Assessment by the Blinded AC

"AC=Adjudication Committee; BVAS=Birmingham Vasculitis Activity Score;~The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 4

Percentage of Subjects Achieving Disease Remission at Week 26

"Disease remission at Week 26 was defined as:~Achieving a BVAS of 0 as determined by the Adjudication Committee;~No administration of glucocorticoids given for ANCA-associated vasculitis within 4 weeks prior to Week 26;~No BVAS >0 during the 4 weeks prior to Week 26 (if collected for an unscheduled assessment)." (NCT02994927)
Timeframe: Week 26

Percentage of Subjects Achieving Sustained Disease Remission at Week 52

"Sustained remission at Week 52 was defined as:~Disease remission at Week 26 as defined above;~Disease remission at Week 52 defined as a BVAS of 0 at Week 52 as determined by the Adjudication Committee and no administration of glucocorticoids for treatment of ANCA-associated vasculitis within 4 weeks prior to Week 52;~No disease relapse between Week 26 and Week 52 as determined by the Adjudication Committee." (NCT02994927)
Timeframe: Week 52

Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving BVAS=0 at Any Time During the Treatment Period

"The median time to relapse was not estimable because of small number of relapsed subjects.~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~The Birmingham Vasculitis Activity Score (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 52

Percentage of Subjects and Time to Experiencing a Relapse After Previously Achieving Remission at Week 26 in the Study

"The median time to relapse was not estimable because of small number of relapsed subjects.~A relapse was defined as occurrence of at least one major item in the BVAS, or three or more minor items in the BVAS, or one or two minor items in the BVAS recorded at two consecutive visits, after:~having achieved remission at Week 26 (BVAS=0 and no glucocorticoids for ANCA-associated vasculitis within 4 weeks) or~having achieved BVAS=0 at any time during the treatment period~ANCA=anti-neutrophil cytoplasmic autoantibody; BVAS=Birmingham Vasculitis Activity Score; The BVAS form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health)." (NCT02994927)
Timeframe: Week 52

Certain Safety Endpoints of Interest: Infections, Hepatic System Abnormalities, WBC Count Decreases, and Hypersensitivity

"WBC=White Blood Cell~TEAE=Treatment-Emergent Adverse Event" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (1/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (2/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (3/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (4/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Hematology (5/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (1/2)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline and Shifts From Baseline in All Safety Laboratory Parameters - Serum Chemistry (2/2)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline in Vital Signs (1/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline in Vital Signs (2/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline in Vital Signs (3/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline in Vital Signs (4/5)

(NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline in Vital Signs (5/5)

BMI=Body Mass Index (NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change From Baseline Over 52 Weeks in Health-related Quality of Life as Measured by the Domains and Component Scores of the SF-36v2 and EQ-5D-5L VAS and Index

"SF-36v2: Measure of health- related quality of life (Medical Outcomes Survey Short Form-36 version 2)~EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels~The SF-36v2 component scores and the EQ-5D-5L VAS score range from 0 (worst health) to 100 (best health). The EQ-5D-5L Index Score ranges from 0 (worst health) to 1 (best health)." (NCT02994927)
Timeframe: Baseline, Week 26 and 52

Change in the VDI From Baseline Over 52 Weeks, Including the Week 26 and Week 52 Time Points

VDI=Vasculitis Damage Index; The VDI is comprised of 64 items of damage, grouped into 11 organ-based systems or categorizations. Damage is defined as the presence of non-healing scars and does not give any indication of current disease activity. Damage is also defined as having been present or currently present for at least 3 months. Completion of the form provides a numerical score, which ranges from 0 (best health) to 64 (worst health). (NCT02994927)
Timeframe: Baseline, Week 26 and 52

Glucocorticoid-induced Toxicity as Measured by Change From Baseline Over the First 26 Weeks in the GTI

"GTI-CWS=Glucocorticoid Toxicity Index Cumulative Worsening Score;~GTI-AIS=Glucocorticoid Toxicity Index Aggregate Improvement Score;~The Glucocorticoid Toxicity Index (GTI) was developed to score glucocorticoid toxicity. The GTI includes: the Cumulative Worsening Score (CWS) that captures cumulative toxicity, both permanent and transient, over the course of time (serves as a cumulative record of toxicity); and the Aggregate Improvement Score that captures both improvement and worsening of toxicity over time (serves as a record of both improving and worsening toxicity). Both scores range from 0 (best health) to 100 (worst health)." (NCT02994927)
Timeframe: Baseline, Week 13 and 26

In Subjects With Renal Disease and Albuminuria at Baseline (Based in the BVAS Renal Component), the Percent Change in UACR From Baseline Over 52 Weeks

"BVAS=Birmingham Vasculitis Activity Score~UACR=Urinary albumin:creatinine ratio" (NCT02994927)
Timeframe: Baseline, Week 4, 26 and 52

In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Change in eGFR From Baseline Over 52 Weeks

"Change from baseline in kidney function, as measured by eGFR (based on the MDRD equation), was measured in subjects with renal disease based on the BVAS renal component.~eGFR=estimated glomerular filtration rate~BVAS=Birmingham Vasculitis Activity Score~MDRD=Modification of Diet in Renal Disease" (NCT02994927)
Timeframe: Baseline, Week 26 and 52

In Subjects With Renal Disease at Baseline (Based in the BVAS Renal Component), the Percent Change in Urinary MCP-1:Creatinine Ratio From Baseline Over 52 Weeks

"BVAS=Birmingham Vasculitis Activity Score~MCP-1=monocyte chemoattractant protein-1" (NCT02994927)
Timeframe: Baseline, Week 26 and 52

Number of Subjects Where a Relationship Between Avacopan/Placebo, Glucocorticoid Use, Cyclophosphamide, Rituximab, and Azathioprine or Mycophenolate Use to an AE Was Determined by the Investigator

AE=Adverse Event (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

Subject Incidence of Treatment-emergent SAEs, AEs, and Withdrawals Due to AEs

"AEs=Adverse events~SAEs=Serious adverse events~TEAE=Treatment-emergent adverse event" (NCT02994927)
Timeframe: From day 1 throughout the study period (day 421/week 60)

Disease Remission

A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease. (NCT00104299)
Timeframe: 6 months post-randomization

Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization

"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 6 months post-randomization

Number of Subjects Experiencing Serious Adverse Events

Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC. (NCT00104299)
Timeframe: Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)

Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy

The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident (NCT00104299)
Timeframe: Through common close-out (defined as 18 months after the last participant is enrolled in the trial)

The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups

"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups

Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing. (NCT00104299)
Timeframe: 18 months post-randomization

Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups

"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups

"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease" (NCT00104299)
Timeframe: 18 months post-randomization

Reviews

4 reviews available for prednisone and ANCA-Associated Vasculitides

Trials

5 trials available for prednisone and ANCA-Associated Vasculitides

Other Studies

30 other studies available for prednisone and ANCA-Associated Vasculitides