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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01714817
Registration number
NCT01714817
Ethics application status
Date submitted
24/10/2012
Date registered
26/10/2012
Date last updated
26/02/2021
Titles & IDs
Public title
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
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Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis
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Secondary ID [1]
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2012-000714-11
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Secondary ID [2]
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IM101-291
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis
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Condition category
Condition code
Renal and Urogenital
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Other renal and urogenital disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BMS-188667
Treatment: Drugs - Mycophenolate mofetil
Treatment: Drugs - Prednisone
Other interventions - Placebo matching with BMS-188667
Experimental: BMS-188667 + Mycophenolate mofetil + Prednisone - BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
Placebo Comparator: Placebo + Mycophenolate mofetil + Prednisone - Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
Other interventions: BMS-188667
Treatment: Drugs: Mycophenolate mofetil
Treatment: Drugs: Prednisone
Other interventions: Placebo matching with BMS-188667
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
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Assessment method [1]
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Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no <85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.
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Timepoint [1]
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Day 365
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Secondary outcome [1]
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Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
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Assessment method [1]
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Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
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Timepoint [1]
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Day 365
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Secondary outcome [2]
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Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants
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Assessment method [2]
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Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants
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Timepoint [2]
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Baseline and Day 365
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Secondary outcome [3]
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Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population
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Assessment method [3]
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Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population
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Timepoint [3]
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Day 1 and Day 365
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Secondary outcome [4]
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Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period
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Assessment method [4]
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Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG "A" represents the presence of serious features of lupus. BILAG "B" represents more moderate features of the disease. BILAG "C" includes only mild symptomatic features. BILAG "D" represents prior activity with no current symptoms due to active lupus. BILAG "E" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.
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Timepoint [4]
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Day 1 to Day 365
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Secondary outcome [5]
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Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
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Assessment method [5]
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All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.
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Timepoint [5]
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From Day 1 up to 56 days post last dose in Year 1 of the double-blind period
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Secondary outcome [6]
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Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
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Assessment method [6]
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Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn
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Timepoint [6]
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Day 365, Day 729
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Secondary outcome [7]
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Median Time to Complete Renal Response During the Double-blind Period in All Participants
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Assessment method [7]
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The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.
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Timepoint [7]
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Day 365, Day 729
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Secondary outcome [8]
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Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants
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Assessment method [8]
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The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.
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Timepoint [8]
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Day 365, Day 729
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Secondary outcome [9]
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Median Time to Partial Renal Response During the Double-blind Period in All Participants
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Assessment method [9]
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The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment
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Timepoint [9]
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Day 365, Day 729
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Secondary outcome [10]
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Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants
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Assessment method [10]
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The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment
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Timepoint [10]
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Day 365, Day 729
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Secondary outcome [11]
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Adjusted Mean Change From Baseline in UPCR Over Time
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Assessment method [11]
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A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.
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Timepoint [11]
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Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy ended
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Secondary outcome [12]
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Median Percent Change From Baseline in UPCR Over Time
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Assessment method [12]
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A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.
% Change from Baseline = (post baseline - baseline value) / baseline value x 100
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Timepoint [12]
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Day 365, Day 729
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Secondary outcome [13]
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Adjusted Mean Change From Baseline in eGFR Over Time
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Assessment method [13]
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Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)a X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years.
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Timepoint [13]
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Day 365, Day 729
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Secondary outcome [14]
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Median Time to First Sustained Change to No Response During the Double-blind Period
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Assessment method [14]
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Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn
The estimate of median time is based on Kaplan-Meier analysis
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Timepoint [14]
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Day 365, Day 729
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Secondary outcome [15]
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Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period
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Assessment method [15]
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Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit.
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Timepoint [15]
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Day 365, Day 729
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Secondary outcome [16]
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Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period
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Assessment method [16]
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BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG "A" represents the presence of one or more serious features of lupus. A BILAG "B" represents more moderate features of the disease. A BILAG "C" includes only mild symptomatic features. A BILAG "D" represents only prior activity with no current symptoms due to active lupus. A BILAG "E" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome.
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Timepoint [16]
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Day 1 to Day 729; Day 365 to Day 729
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Secondary outcome [17]
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Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
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Assessment method [17]
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Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365
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Timepoint [17]
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Days 1 to 365
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Secondary outcome [18]
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Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV
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Assessment method [18]
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Cmax: Maximum observed serum concentration following participants receiving active abatacept IV
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Timepoint [18]
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at 1 hour post Day 1 dose and 30 minutes post Day 337 dose
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Secondary outcome [19]
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AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval
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Assessment method [19]
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AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.
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Timepoint [19]
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Days 337 to 365
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Secondary outcome [20]
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Summary Statistics for Systolic Blood Pressure
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Assessment method [20]
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Summary statistics for systolic blood pressure
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Timepoint [20]
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Day 1 to Day 729
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Secondary outcome [21]
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Summary Statistics for Diastolic Blood Pressure
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Assessment method [21]
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Summary statistics for diastolic blood pressure
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Timepoint [21]
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Day 1 to Day 729
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Secondary outcome [22]
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Summary Statistics for Heart Rate
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Assessment method [22]
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Summary statistics for Heart Rate
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Timepoint [22]
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Day 1 to Day 729
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Secondary outcome [23]
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
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Assessment method [23]
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Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
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Timepoint [23]
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Day 729
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Secondary outcome [24]
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)
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Assessment method [24]
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Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
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Timepoint [24]
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Day 729
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Secondary outcome [25]
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)
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Assessment method [25]
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Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
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Timepoint [25]
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Day 729
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Secondary outcome [26]
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)
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Assessment method [26]
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Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
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Timepoint [26]
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Day 729
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Secondary outcome [27]
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
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Assessment method [27]
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Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
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Timepoint [27]
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Day 729
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Secondary outcome [28]
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Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
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Assessment method [28]
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Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.
Change from Baseline = Post-baseline - Baseline value.
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Timepoint [28]
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Day 729
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Secondary outcome [29]
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Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
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Assessment method [29]
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LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX<LLN THEN USE 0.5X PRE RX AND <100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.8X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR <LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE > .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL
N = the number of participants with at least 1 on treatment lab result for each analyte
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Timepoint [29]
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Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
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Secondary outcome [30]
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Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
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Assessment method [30]
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LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX
N = the number of participants with at least 1 on treatment lab result for each analyte
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Timepoint [30]
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Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
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Secondary outcome [31]
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Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
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Assessment method [31]
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LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RX<LLN THEN USE <0.95X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR <LLN POTASSIUM, SERUM mmol/L 4.1 K <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN CHLORIDE, SERUM mmol/L 5.0 CL <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN
N = the number of participants with at least 1 on treatment lab result for each analyte
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Timepoint [31]
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Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
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Secondary outcome [32]
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Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
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Assessment method [32]
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LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4
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Timepoint [32]
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Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
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Secondary outcome [33]
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Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
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Assessment method [33]
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LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR <LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.67X PRE RX OR >ULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE 0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR <LLN ALBUMIN g/L 3.0 ALB <0.9X LLN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL >2X PRE R
N = the number of participants with at least 1 on treatment lab result for each analyte
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Timepoint [33]
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Day 1 to Day 365; includes data up to 56 days post last dose in year 1 of double-blind period or first dose date in the year 2 of double-blind period, whichever is earlier
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Secondary outcome [34]
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Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
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Assessment method [34]
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All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.
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Timepoint [34]
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From the first dose in Year 2 of the double-blind period up to 56 days post last dose
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Secondary outcome [35]
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0
Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
Query!
Assessment method [35]
0
0
Lupus treatment failure is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.
Query!
Timepoint [35]
0
0
Day 365, Day 729
Query!
Secondary outcome [36]
0
0
Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period
Query!
Assessment method [36]
0
0
First treatment failure (or Lupus treatment failure) is defined as any of the following: Death, unless due to physical trauma or violence; Renal Flare; sustained doubling of creatinine from baseline (greater of Screening or Study Day 1 value); initiation of rescue therapy for treatment of active lupus nephritis after Study Week 20.
Overall treatment failure is defined as lupus treatment failure plus discontinuation of study drug for any reason except death due to physical trauma or violence, pregnancy or administrative decision by Sponsor.
The hazard ratio is estimated using the Cox proportional hazards model which includes treatment group, stratification variables (baseline ACEis/ARBs use, RACE) and baseline UPCR.
The estimate of median time is based on Kaplan-Meier analysis
Query!
Timepoint [36]
0
0
Day 365, Day 729
Query!
Secondary outcome [37]
0
0
Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
Query!
Assessment method [37]
0
0
Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
Query!
Timepoint [37]
0
0
Day 729
Query!
Secondary outcome [38]
0
0
Percentage of Participants in Overall Population in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
Query!
Assessment method [38]
0
0
Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.
Query!
Timepoint [38]
0
0
Day 729
Query!
Secondary outcome [39]
0
0
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
Query!
Assessment method [39]
0
0
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX<LLN THEN USE 0.5X PRE RX AND <100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.8X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR <LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE > .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL
N = the number of participants with at least 1 on treatment lab result for each analyte
Query!
Timepoint [39]
0
0
Day 1 to Day 729
Query!
Secondary outcome [40]
0
0
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
Query!
Assessment method [40]
0
0
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX
N = the number of participants with at least 1 on treatment lab result for each analyte
Query!
Timepoint [40]
0
0
Day 1 to Day 729
Query!
Secondary outcome [41]
0
0
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
Query!
Assessment method [41]
0
0
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RX<LLN THEN USE <0.95X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR <LLN POTASSIUM, SERUM mmol/L 4.1 K <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN CHLORIDE, SERUM mmol/L 5.0 CL <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN
N = the number of participants with at least 1 on treatment lab result for each analyte
Query!
Timepoint [41]
0
0
Day 1 to Day 729
Query!
Secondary outcome [42]
0
0
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
Query!
Assessment method [42]
0
0
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4
Query!
Timepoint [42]
0
0
Day 1 to Day 729
Query!
Secondary outcome [43]
0
0
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
Query!
Assessment method [43]
0
0
LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR <LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.67X PRE RX OR >ULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE 0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR <LLN ALBUMIN g/L 3.0 ALB <0.9X LLN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL >2X PRE R
N = the number of participants with at least 1 on treatment lab result for each analyte
Query!
Timepoint [43]
0
0
Day 1 to Day 729
Query!
Secondary outcome [44]
0
0
Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period
Query!
Assessment method [44]
0
0
Participants who experienced a positive antibody response relative to baseline (ECL Assay)
Query!
Timepoint [44]
0
0
Day 365, Day 729
Query!
Eligibility
Key inclusion criteria
For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching
Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on
clinical trial participation.
Note: Subjects > 16 are eligible for enrollment at selected centers
- Potential subjects must have active lupus nephritis
- Biopsy within 12 months prior to screening visit indicating active Class 3 or 4
proliferative lupus glomerulonephritis (lupus effecting your kidney)
- Urine protein creatinine ratio (UPCR) = 1 at Screening
- Serum creatinine = 3 mg/dL (ie, = 265 micromol/L)
- There must also be evidence of active disease within 3 months of Screening, based on
at least one of the following:
- Worsening of lupus nephritis OR
- UPCR = 3 at Screening OR
- Active urine sediment OR
- Biopsy within 3 months prior to screening visit indicating active Class 3 or
Class 4 active proliferative lupus glomerulonephritis
Inclusion Criteria for the Long-Term Extension Period:
- Signed Written Informed Consent
- Subjects who achieve a complete or partial renal response after completing 2 years of
double-blind treatment
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis
- Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,
hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
cerebral disease, or other concomitant medical conditions that, in the opinion of the
Investigator, might place the subject at unacceptable risk for participation in this
study
- Significant active Central nervous system (CNS) lupus with the exception of fatigue or
mild stable cognitive
- Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too
significant and irreversible
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
22/01/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/05/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
695
Query!
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Adelaide
Query!
Recruitment hospital [2]
0
0
Local Institution - Parkville
Query!
Recruitment hospital [3]
0
0
Local Institution - Perth
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [3]
0
0
6009 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Louisiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Ohio
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Utah
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Virginia
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Buenos Aires
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Cordoba
Query!
Country [19]
0
0
Brazil
Query!
State/province [19]
0
0
Bahia
Query!
Country [20]
0
0
Brazil
Query!
State/province [20]
0
0
Goias
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Minas Gerais
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Rio Grande Do Sul
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Sao Paulo
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Ontario
Query!
Country [25]
0
0
Chile
Query!
State/province [25]
0
0
Metropolitana
Query!
Country [26]
0
0
Chile
Query!
State/province [26]
0
0
Santiago
Query!
Country [27]
0
0
Chile
Query!
State/province [27]
0
0
Valparaiso
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Beijing
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Guangdong
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Hainan
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Hebei
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Heilongjiang
Query!
Country [33]
0
0
China
Query!
State/province [33]
0
0
Henan
Query!
Country [34]
0
0
China
Query!
State/province [34]
0
0
Jiangsu
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Jiangxi
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Shan1xi
Query!
Country [37]
0
0
China
Query!
State/province [37]
0
0
Shanghai
Query!
Country [38]
0
0
China
Query!
State/province [38]
0
0
Sichuan
Query!
Country [39]
0
0
China
Query!
State/province [39]
0
0
Zhejiang
Query!
Country [40]
0
0
China
Query!
State/province [40]
0
0
Chong Qing
Query!
Country [41]
0
0
China
Query!
State/province [41]
0
0
Guangzhou
Query!
Country [42]
0
0
China
Query!
State/province [42]
0
0
Nanchang
Query!
Country [43]
0
0
China
Query!
State/province [43]
0
0
Nanning
Query!
Country [44]
0
0
China
Query!
State/province [44]
0
0
Xi'An
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Cundinamarca
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Santander
Query!
Country [47]
0
0
Colombia
Query!
State/province [47]
0
0
Barranquilla
Query!
Country [48]
0
0
Colombia
Query!
State/province [48]
0
0
Bogota
Query!
Country [49]
0
0
Colombia
Query!
State/province [49]
0
0
Medellin
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Praha 2
Query!
Country [51]
0
0
Hong Kong
Query!
State/province [51]
0
0
Hong Kong
Query!
Country [52]
0
0
India
Query!
State/province [52]
0
0
Andhra Pradesh
Query!
Country [53]
0
0
India
Query!
State/province [53]
0
0
Gujrat
Query!
Country [54]
0
0
India
Query!
State/province [54]
0
0
Gurgaon
Query!
Country [55]
0
0
India
Query!
State/province [55]
0
0
Hyderabad
Query!
Country [56]
0
0
India
Query!
State/province [56]
0
0
Lucknow-
Query!
Country [57]
0
0
India
Query!
State/province [57]
0
0
New Delhi
Query!
Country [58]
0
0
Israel
Query!
State/province [58]
0
0
Haifa
Query!
Country [59]
0
0
Israel
Query!
State/province [59]
0
0
Ramat-gan
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Tel Aviv
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Brescia
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Milano
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Padova
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Reggio Emilia
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Torino
Query!
Country [66]
0
0
Japan
Query!
State/province [66]
0
0
Aichi
Query!
Country [67]
0
0
Japan
Query!
State/province [67]
0
0
Chiba
Query!
Country [68]
0
0
Japan
Query!
State/province [68]
0
0
Fukuoka
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Gunma
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Hokkaido
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Ishikawa
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Kanagawa
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Miyagi
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Nagasaki
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Niigata
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Okayama
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Saitama
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Tochigi
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Tokyo
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Kita-gun
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Osaka
Query!
Country [82]
0
0
Korea, Republic of
Query!
State/province [82]
0
0
Daegu
Query!
Country [83]
0
0
Korea, Republic of
Query!
State/province [83]
0
0
Seoul
Query!
Country [84]
0
0
Mexico
Query!
State/province [84]
0
0
Distrito Fededral
Query!
Country [85]
0
0
Mexico
Query!
State/province [85]
0
0
Distrito Federal
Query!
Country [86]
0
0
Mexico
Query!
State/province [86]
0
0
Jalisco
Query!
Country [87]
0
0
Mexico
Query!
State/province [87]
0
0
Yucatan
Query!
Country [88]
0
0
Mexico
Query!
State/province [88]
0
0
San Luis Potosi
Query!
Country [89]
0
0
Peru
Query!
State/province [89]
0
0
Lima
Query!
Country [90]
0
0
Puerto Rico
Query!
State/province [90]
0
0
San Juan
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Country [91]
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Romania
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State/province [91]
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Bucharest
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Country [92]
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Romania
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State/province [92]
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Bucuresti
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Country [93]
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Romania
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State/province [93]
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Cluj-napoca
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Country [94]
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Romania
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State/province [94]
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Iasi
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Country [95]
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Russian Federation
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State/province [95]
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Moscow
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Country [96]
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Russian Federation
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State/province [96]
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St. Petersburg
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Country [97]
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Russian Federation
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State/province [97]
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Ufa
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Country [98]
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Spain
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State/province [98]
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Madrid
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Country [99]
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Taiwan
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State/province [99]
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Kaohsiung
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Country [100]
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Taiwan
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State/province [100]
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Taichung
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Country [101]
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Taiwan
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State/province [101]
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Taipei
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Country [102]
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Taiwan
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State/province [102]
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Taoyuan
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Country [103]
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Turkey
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State/province [103]
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Antalya
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Country [104]
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Turkey
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State/province [104]
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Edirne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when
used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01714817
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01714817
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