chloroquine and Lupus Erythematosus, Systemic

chloroquine has been researched along with Lupus Erythematosus, Systemic in 399 studies

Chloroquine: The prototypical antimalarial agent with a mechanism that is not well understood. It has also been used to treat rheumatoid arthritis, systemic lupus erythematosus, and in the systemic therapy of amebic liver abscesses.
chloroquine : An aminoquinoline that is quinoline which is substituted at position 4 by a [5-(diethylamino)pentan-2-yl]amino group at at position 7 by chlorine. It is used for the treatment of malaria, hepatic amoebiasis, lupus erythematosus, light-sensitive skin eruptions, and rheumatoid arthritis.

Lupus Erythematosus, Systemic: A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow.

Research

Studies (399)

Authors

Clinical Trials (60)

Trial Overview

Trial Outcomes

Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.

Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions. (NCT01597050)
Timeframe: Up to Week 4

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score

"The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The total FACIT-Fatigue score ranges from 0 to 52. Note: Data presented is Adjusted mean data." (NCT03161483)
Timeframe: Week 24

Mean Change From Baseline in PGA Score

The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. (NCT03161483)
Timeframe: Week 24

Mean Change From Baseline in Swollen Joint Count in Participants With ≥ 2 Swollen Joints at Baseline

"Joint tenderness and swelling will be noted as present or absent, with no quantitation of severity using a 28- joint count. Note: Data presented is Adjusted mean data." (NCT03161483)
Timeframe: Week 24

Mean Change From Baseline in Tender Joint Count in Participants With ≥ 2 Tender Joints at Baseline

"Joint tenderness and swelling will be noted as present or absent, with no quantitation of severity using a 28- joint count. Note: Data presented is Adjusted mean data." (NCT03161483)
Timeframe: Week 24

Number of Participants Who Achieve SLE Responder Index (SRI) (4) Response

The primary objective is to evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day [QD], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active systemic lupus erythematosus (SLE) using the SLE Responder Index at Week 24 Composite endpoint SRI(4), defined by the following criteria: - Reduction from Baseline of ≥ 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score and - No new one or more British Isles Lupus Assessment Group (BILAG) A or new (excludes A to B) 2 or more BILAG B items compared to Baseline using BILAG 2004 Index and - No worsening from Baseline defined by an increase of < 0.30 points from Baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3 (NCT03161483)
Timeframe: Week 24

Number of Participants With a ≥ 50% Reduction in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score From Baseline, in Participants With Baseline CLASI Activity Score ≥ 10

The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and non-scarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. (NCT03161483)
Timeframe: Week 24

Number of Participants With no New Organ System Affected as Defined by 1 or More BILAG A or New (Excludes A to B) 2 or More BILAG B Items Compared to Baseline Using BILAG 2004 Index

The BILAG 2004 is a composite index that is based on the Classic BILAG index. It is a clinical measure of lupus disease activity. This tool assesses the changing severity of clinical manifestations of SLE using an ordinal scale scoring system that contain 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological). Activity in each organ system is scored as: A=most active disease; B=intermediate activity; C=mild, stable disease; D=previous involvement, currently inactive; E=no previous activity. (NCT03161483)
Timeframe: Week 24

Number of Participants With SLEDAI 2K Score Improvement of ≥ 4 Points From Baseline

The SLEDAI 2K score measures disease activity through assessment of 24 lupus manifestations using a weighted score of 1 to 8 points. A manifestation is recorded if it is present over the previous 30 days regardless of severity or whether it has improved or worsened. A SLEDAI 2K score of 3 to 4 points is representative of active disease and a decrease of 1 to 2 points is considered clinically meaningful. (NCT03161483)
Timeframe: Week 24

Percent Change From Baseline in Corticosteroid Reduction

Percent change from Baseline in oral corticosteroid (OCS) dose in subjects with prednisone or equivalent ≥ 10 mg/day at Baseline Note: Data presented is Adjusted mean data. (NCT03161483)
Timeframe: Week 24

Percentage of Participants With no Worsening (Increase of < 0.30 Points From Baseline) in PGA Compared to Baseline

The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. (NCT03161483)
Timeframe: Week 24

The Total Corticosteroid Dose From Baseline Through Week 24

Standardized total oral corticosteroid (OCS) dose. (NCT03161483)
Timeframe: Through Week 24

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Number of participants who experienced a TEAE during the course of the study (NCT03161483)
Timeframe: from first dose to 28 days post-last dose through Week 24 (placebo-controlled phase), approximately 28 weeks total

Percentage of Participants With Corticosteroid Reduction

- The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to ≤ 7.5 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24 - The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to < 10 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24 (NCT03161483)
Timeframe: Week 24

Area Under the Curve (AUC) of BILAG Score at Week 52

The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score. (NCT00071487)
Timeframe: Baseline and every 4 to 8 weeks through Week 52

Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score. (NCT00071487)
Timeframe: Baseline and every 4 to 8 weeks through Week 52

Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52

The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0. (NCT00071487)
Timeframe: Baseline, 52 weeks

Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. (NCT00071487)
Timeframe: Baseline, 24 weeks

Percentage Change From Baseline in SELENA SLEDAI Score at Week 52

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare (NCT00071487)
Timeframe: Baseline, 52 weeks

Percentage of Patients With a Reduction in Prednisone Dose

Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline. (NCT00071487)
Timeframe: Baseline, weeks 40 to 52

Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)

"The SLE Flare Index categorized SLE flare as mild or moderate or severe based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe)." (NCT00071487)
Timeframe: 0 to 52 weeks

Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks

SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit. (NCT00071487)
Timeframe: 0 to 52 weeks

Adverse Events (AE) Overview

Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362). (NCT00071487)
Timeframe: Up to 84 weeks

Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

A TEAE was defined as any adverse event (AE) starting on or after the first dose of investigational product through to the safety follow-up visit. Any clinically significant changes in physical examinations, vital signs, and clinical laboratory test results were recorded as AEs. (NCT03451422)
Timeframe: Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up)

Area Under the Concentration-time Curve Over a Dosing Interval (AUCtau) for AMG 592

(NCT03451422)
Timeframe: Day 1 (pre-dose) and 6 to 72 hours post-dose, and Days 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, Day 85 (pre-dose) and 6 to 72 hours post-dose, and Days 92, 99, 113 and 127

Maximum Observed Concentration (Cmax) for AMG 592

(NCT03451422)
Timeframe: Day 1 (pre-dose) and 6 to 72 hours post-dose, and Days 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, Day 85 (pre-dose) and 6 to 72 hours post-dose, and Days 92, 99, 113 and 127

Number of Participants With Anti-AMG 592 Binding Antibodies and Anti-Interleukin (IL-2) Binding Antibodies

Number of participants who tested positive for developing anti-AMG 592 or anti-IL-2 binding antibodies at 1 or more post-baseline time points, with a negative or no result at baseline, are reported. (NCT03451422)
Timeframe: Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up)

Number of Participants With Anti-AMG 592 Binding Antibodies and Anti-Interleukin (IL-2) Binding Antibodies

Number of participants who tested positive for developing anti-AMG 592 or anti-IL-2 binding antibodies at 1 or more post-baseline time points, with a negative or no result at baseline, are reported. (NCT03451422)
Timeframe: Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up)

Number of Participants With Anti-AMG 592 Neutralizing Antibodies and Anti-IL-2 Neutralizing Antibodies

Number of participants who tested positive for developing anti-AMG 592 or anti-IL-2 neutralizing antibodies at 1 or more post-baseline time points, with a negative or no result at baseline, are reported. (NCT03451422)
Timeframe: Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up)

Number of Participants With Anti-AMG 592 Neutralizing Antibodies and Anti-IL-2 Neutralizing Antibodies

Number of participants who tested positive for developing anti-AMG 592 or anti-IL-2 neutralizing antibodies at 1 or more post-baseline time points, with a negative or no result at baseline, are reported. (NCT03451422)
Timeframe: Day 1 up to end of study, maximum of 18 weeks (12-week double-blind treatment, 6-week safety follow-up)

Time of Cmax (Tmax) for AMG 592

(NCT03451422)
Timeframe: Day 1 (pre-dose) and 6 to 72 hours post-dose, and Days 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, Day 85 (pre-dose) and 6 to 72 hours post-dose, and Days 92, 99, 113 and 127

Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response

"BICLA responder is defined as a patient whose disease course fulfills all of the following:~Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline~No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B~No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score)~No increase ≥ 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity~No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment" (NCT03252587)
Timeframe: At week 48

Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)

"LLDAS is defined as follows:~SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System~No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters~Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity~A current prednisolone (or equivalent) dose ≤ 7.5 mg daily~Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents" (NCT03252587)
Timeframe: At Week 48

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32

"SRI(4) responder is defined as a patient whose disease course fulfills all of the following:~A 4-point or greater reduction from baseline in SLEDAI-2K score~No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade~No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity" (NCT03252587)
Timeframe: At week 32

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48

"SRI(4) responder is defined as a patient whose disease course fulfills all of the following:~A 4-point or greater reduction from baseline in SLEDAI-2K score~No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade~No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity" (NCT03252587)
Timeframe: At week 48

Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10

Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia (NCT03252587)
Timeframe: At week 48

Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels

Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose. (NCT03252587)
Timeframe: From baseline to week 52

Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32

Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose. (NCT03252587)
Timeframe: From baseline to week 32

BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)

Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. (NCT03252587)
Timeframe: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12

BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)

Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. (NCT03252587)
Timeframe: Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12

BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)

Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported. (NCT03252587)
Timeframe: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48

Change From Baseline in the 40-Joint Count

"Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of:~Tender joint count (0 to 40)~Swollen joint count (0 to 40)~Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease." (NCT03252587)
Timeframe: Baseline and week 48

Number of Participants With Abnormalities in Electrocardiograms (ECGs)

Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval (NCT03252587)
Timeframe: From baseline to up to week 48

Number of Participants With Abnormalities in Vital Signs

Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure (NCT03252587)
Timeframe: From first dose to 30 days post last dose (Up to 52 weeks)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment (NCT03252587)
Timeframe: From first dose to 30 days post last dose (Up to 52 weeks)

Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status

"Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following:~A 4-point or greater reduction from baseline in SLEDAI-2K score~No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade~No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity" (NCT03252587)
Timeframe: At week 32

Number of Participants With Laboratory Abnormalities in Specific Liver Tests

"Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following:~Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN)~Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase)~No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic" (NCT03252587)
Timeframe: From first dose to 30 days post last dose (Up to 52 weeks)

Percent Change From Baseline in Complement (C3, C4) Levels at Week 32

Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose. (NCT03252587)
Timeframe: From baseline to week 32

Percent Change From Baseline in Complement Proteins C3 and C4 Levels

Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose. (NCT03252587)
Timeframe: From baseline to week 52

Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels

Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose. (NCT03252587)
Timeframe: From baseline to week 44

Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32

Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose. (NCT03252587)
Timeframe: From baseline to week 32

Number and Percentage of Subjects Who Achieved a Response at Week 24 According to the Modified British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (mBICLA) Score

"The primary endpoint was evaluated by determining if there was a dose-response relationship between the mBICLA response rate at Week 24 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. The existence of several candidate parametric models was assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve. The selected model could further be used to guide the choice of adequate doses.~mBICLA responders were defined as subjects who met all of the following criteria:~BILAG-2004 normal improvement: all A scores at Baseline improved to B, C or D, and all B scores improved to C or D.~No worsening in disease activity: no new BILAG-2004 A scores and ≤ 1 new increase to B.~No worsening of total mSLEDAI-2K score from Baseline.~No significant deterioration (< 10% worsening from Baseline) in PGA.~No treatment failure (including the premature" (NCT02437890)
Timeframe: At Week 24 visit

Number and Percentage of Subjects Who Were Treatment-emergent (TE) Anti-drug Antibody (ADA) Positive

(NCT02437890)
Timeframe: From first administration of ALX-0061 up to and including follow-up

Actual Values for Hemolytic Complement Component 50 (CH50) at Baseline, Week 24, and Week 48

(NCT02437890)
Timeframe: At Baseline, Week 24, and Week 48

Actual Values of Anti-double-stranded (ds) DNA Concentrations at Baseline, Week 24, and Week 48

(NCT02437890)
Timeframe: at Baseline, Week 24, and Week 48

Actual Values of C-reactive Protein (CRP) Concentrations at Baseline, Week 24, and Week 48

(NCT02437890)
Timeframe: At Baseline, Week 24, and Week 48

Actual Values of Complement C3 Concentrations at Baseline, Week 24, and Week 48

(NCT02437890)
Timeframe: At Baseline, Week 24, and Week 48

Actual Values of Complement C4 Concentrations at Baseline, Week 24, and Week 48

(NCT02437890)
Timeframe: At Baseline, Week 24, and Week 48

Actual Values of Fibrinogen Concentrations at Baseline, Week 24, and Week 48

(NCT02437890)
Timeframe: At Baseline, Week 24, and Week 48

Actual Values of Soluble Interleukin 6 Receptor (sIL-6R) Concentrations at Baseline, Week 24, and Week 48

(NCT02437890)
Timeframe: At Baseline, Week 24, and Week 48

ALX-0061 Serum Concentrations at Week 24 and Week 48

(NCT02437890)
Timeframe: At Week 24 and Week 48

BILAG-2004 Total Score at Baseline, Week 24 and Week 48

"The British Isles Lupus Assessment Group 2004 (BILAG-2004) is a comprehensive composite clinical index that has been developed based on the principle of a physician's intention to treat using a nominal consensus approach. In the index, the nine systems (not organs) considered are: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, renal, ophthalmic and hematological. Disease activity in each of the nine systems is categorized into five levels: grades A (= severe disease activity requiring systemic high dose oral corticosteroids, i.v. pulse corticosteroids, etc.) to E (= system never involved).~BILAG total score is derived by assigning the following value to each grade and summing the sores over all organ systems:~A = 12, B = 8, C = 1, D/E = 0. The total score ranges from 0-108, with 108 representing high disease activity in all 9 systems requiring high doses of corticosteroids, starting/increasing immunosuppressive drugs, etc." (NCT02437890)
Timeframe: At Baseline, Week 24 and Week 48

Change From Baseline in 28 Joint Count Swollenness (SJC28) Score at Week 24 and Week 48

Twenty-eight joints are assessed for swollenness (a score of 1 for a joint denotes a presence of swollenness). The sum is derived to create a total score (ranging from 0 to 28; where the highest score indicate all 28 joints are swollen). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SJC28 Score and geographic region as covariates. A negative change denotes an improvement. (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in 28 Joint Count Tenderness (TJC28) Score at Week 24 and Week 48

Twenty-eight joints are assessed for tenderness (a score of 1 for a joint denotes a presence of tenderness). The sum is derived to create a total score (ranging from 0 to 28; where the highest score indicate all 28 joints are tender). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline TJC28 Score and geographic region as covariates. A negative change denotes and improvement. (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in CLASI Damage Score at Week 12, Week 24 and Week 48

"CLASI Damage is scored based on dyspigmentation and scarring. Evaluation of dyspigmentation and scarring is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area (dyspigmentation: 0=absent, 1=present; scarring: 0=absent, 1=scarring, 2=severely atrophic scarring or panniculitis). Subjects are also asked whether dyspigmentation due to SLE lesions usually remains visible for >12 months, which is considered permanent and results in doubling of the dyspigmentation score. Scarring alopecia is scored as follows: 0=absent, 3=1 quadrant, 4=2 quadrants, 5=3 quadrants, 6=affects the whole skull. Total score ranges from 0-56, with higher scores indicating more damaged skin.~Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline CLASI Damage Score and geographic region as covariates. Negative change = improvement." (NCT02437890)
Timeframe: At Week 12, Week 24 and Week 48

Change From Baseline in Creatinine Clearance Estimation (eGFR) at Week 24 and Week 48

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline eGFR and geographic region as covariates (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12, Week 24 and Week 48

"CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area (erythema: 0=absent, 1=pink, 2=red, 3=dark red; scale: 0=absent, 1=scale, 2=verrucous/hypertrophic). Mucous membrane involvement and acute hair loss are scored based on the presence (=1) or absence (=0).~Nonscarring alopecia is scored as 0=absent, 1=diffuse/non-inflammatory, 2=focal or patchy in 1 quadrant, 3=focal or patchy in >1 quadrant. The total score ranges from 0-70, with higher scores indicating more severe skin disease.~Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline CLASI Activity Score and geographic region as covariates. Negative change = improvement" (NCT02437890)
Timeframe: At Week 12, Week 24 and Week 48

Change From Baseline in Mental Component Scores of SF-36 at Week 24 and Week 48

"The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.~Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SF-36 Score and geographic region as covariates. A positive change denotes an improvement." (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in Modified Systemic Lupus Erythematosus Disease Activity Index 2000 (mSLEDAI-2K) Score at Week 24 and Week 48

The Systemic Lupus Erythematosus Disease Activity Index 2000 is a 1-page weighted score for 24 items (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, etc). The manifestations felt to be most commonly contributing to disease activity are included and scored based on the presence (= 1 multiplied by weight) or absence (= 0) within 30 days prior to the evaluation. The total score ranges from 0-105 (= sum of individual scores), with 105 being higher disease activity. mSLEDAI-2K derives from the standard index by omitting low complement. Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline mSLEDAI-2K Score and geographic region as covariates. A negative change from baseline reflects an improvement. (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in Patient's Global Assessment at Week 24 and Week 48

"The subject makes a mark between 0 (very good) and 100 mm (very bad) on the VAS to indicate how the subject is doing, while considering all the ways SLE affects him/her.~Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline Patient's Global Assessment and geographic region as covariates.~A negative change from baseline reflects an improvement." (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in Physical Component Scores of Short Form (36) Health Survey (SF-36) at Week 24 and Week 48

"The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.~Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SF-36 Score and geographic region as covariates. A positive change denotes an improvement." (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in Physician's Global Assessment (PGA) at Week 24 and Week 48

"The physician makes a mark between 0 (no disease) and 100 mm (severe disease) on the visual analogue scale (VAS) to indicate disease activity (independent of the subject's self-assessment).~Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline PGA score and geographic region as covariates.~A negative change from baseline reflects an improvement." (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in Proteinuria at Week 24 and Week 48

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline proteinuria and geographic region as covariates (NCT02437890)
Timeframe: At Week 24 and Week 48

Change From Baseline in Serum Creatinine at Week 24 and Week 48

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline serum creatinine and geographic region as covariates (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects Experiencing Severe Flares According to BILAG-2004 Flare Index From Baseline to Week 24 and Week 48

(NCT02437890)
Timeframe: From Baseline to Week 24 and Week 48

Number and Percentage of Subjects Experiencing Severe Flares According to mSLEDAI-2K Flare Index (mSFI) From Baseline to Week 24 and Week 48

(NCT02437890)
Timeframe: From Baseline to Week 24 and Week 48

Number and Percentage of Subjects Who Discontinued Prednisone (or Equivalent) by Week 48 Without Experiencing a Severe Flare

Number and percentage of subjects who discontinued Prednisone (or equivalent) by Week 48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare (NCT02437890)
Timeframe: Up to and including Week 48

Number and Percentage of Subjects Whose Daily Dose of Steroids Was Reduced Without Severe Flares During Weeks 40-48

Number and percentage of subjects whose prednisone equivalent dose was >7.5 mg/day at baseline and reduced to ≤7.5 mg/day during Weeks 40-48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare after the first prednisone equivalent dose decrease. (NCT02437890)
Timeframe: Between Week 40 and Week 48

Number and Percentage of Subjects With BILAG-2004 Enhanced Improvement at Week 24 and Week 48

Enhanced improvement: all A scores at baseline improved to B/C/D, and all B scores improved to C or D and no worsening between consecutive visits from baseline up to the considered visit Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With BILAG-2004 Normal Improvement at Week 24 and Week 48

"Normal Improvement: all A scores at baseline improved to B/C/D, and all B scores improved to C or D.~Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint" (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Mucocutaneous System at Week 24 and Week 48

"An improvement is defined as an A score at Baseline improved to B/C/D, or a B score improved to C or D.~Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint" (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Musculoskeletal System at Week 24 and Week 48

"An improvement is defined as an A score at Baseline improved to B/C/D, or a B score improved to C or D.~Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint" (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With mBICLA Response at Week 24 and Week 48

Number and percentage of mBICLA responders at Week 24 and Week 48 (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With Modified Systemic Lupus Erythematosus Responder Index (mSRI-4) Response at Week 24 and Week 48

"The composite index mSRI-4 enables quantification of decrease and increase in disease activity in a broad spectrum of manifestations thereby offering a comprehensive assessment of SLE disease status. mSRI combines advantages from 3 validated measurement tools. The mSRI-4 criteria for response are:~modified SLE disease activity index 2000 (mSLEDAI-2K): ≥ 4 point reduction (covers global disease improvement),~British Isles Lupus Assessment Group 2004 (BILAG-2004): no new A domain score and no more than 1 new increase to B (covers organ-specific disease improvement),~Physician's Global Assessment (PGA) (is used as validity and safety net for items that were not addressed by the other two indices): < 10% increase from Baseline (no worsening) When all 3 criteria are met, the subject is a mSRI-4 responder at that time point.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation." (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With mSRI-5 Response at Week 24 and Week 48

"The mSRI-5 criteria for response are:~mSLEDAI-2K: ≥ 5 point reduction~BILAG-2004: no new A domain score and no more than 1 new increase to B domain score~PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 5 were considered for the derivation of that endpoint.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation." (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With mSRI-6 Response at Week 24 and Week 48

"The mSRI-6 criteria for response are:~mSLEDAI-2K: ≥ 6 point reduction~BILAG-2004: no new A domain score and no more than 1 new increase to B domain score~PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 6 were considered for the derivation of that endpoint.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation" (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With mSRI-7 Response at Week 24 and Week 48

"The mSRI-7 criteria for response are:~mSLEDAI-2K: ≥ 7 point reduction~BILAG-2004: no new A domain score and no more than 1 new increase to B domain score~PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 7 were considered for the derivation of that endpoint.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation." (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With mSRI-8 Response at Week 24 and Week 48.

"The mSRI-8 criteria for response are:~mSLEDAI-2K: ≥ 8 point reduction~BILAG-2004: no new A domain score and no more than 1 new increase to B domain score~PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 8 were considered for the derivation of that endpoint.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation." (NCT02437890)
Timeframe: At Week 24 and Week 48

Number and Percentage of Subjects With Persistent Minimal or no Activity in 9 Organ Systems According to BILAG-2004 Systems Tally at Week 24 and Week 48

(NCT02437890)
Timeframe: At Week 24 and Week 48

Number of and Percentage Treatment Failures From Baseline to Week 24 and Week 48

Defined as non-protocol allowed increase in steroid dose, start i.v. or i.m. steroids, or start or increase of immunosuppressant (NCT02437890)
Timeframe: From Baseline to Week 24 and Week 48

Number of Subjects Who Were Treatment-emergent Urine Sediment Positive at Week 24 and Week 48

Efficacy Laboratory Parameters (Urinalysis) - Active Urine Sediment Number of subjects who were urine sediment negative at Baseline, but positive at Week 24 and Week 48, respectively. (NCT02437890)
Timeframe: At Week 24 and Week 48

Percent Change From Baseline in Daily Dose of Steroids at Week 24 and Week 48

Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline prednisone equivalent total daily dose and geographic region as covariates (NCT02437890)
Timeframe: At Week 24 and Week 48

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

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

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