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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2012-000714-11
Secondary ID [2] 0 0
IM101-291
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Nephritis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
Timepoint [1] 0 0
Day 365
Secondary outcome [1] 0 0
Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period
Timepoint [1] 0 0
Day 365
Secondary outcome [2] 0 0
Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants
Timepoint [2] 0 0
Baseline and Day 365
Secondary outcome [3] 0 0
Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population
Timepoint [3] 0 0
Day 1 and Day 365
Secondary outcome [4] 0 0
Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period
Timepoint [4] 0 0
Day 1 to Day 365
Secondary outcome [5] 0 0
Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period
Timepoint [5] 0 0
From Day 1 up to 56 days post last dose in Year 1 of the double-blind period
Secondary outcome [6] 0 0
Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period
Timepoint [6] 0 0
Day 365, Day 729
Secondary outcome [7] 0 0
Median Time to Complete Renal Response During the Double-blind Period in All Participants
Timepoint [7] 0 0
Day 365, Day 729
Secondary outcome [8] 0 0
Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants
Timepoint [8] 0 0
Day 365, Day 729
Secondary outcome [9] 0 0
Median Time to Partial Renal Response During the Double-blind Period in All Participants
Timepoint [9] 0 0
Day 365, Day 729
Secondary outcome [10] 0 0
Median Time to Partial Renal Response During the Double-blind Period in Nephrotic Participants
Timepoint [10] 0 0
Day 365, Day 729
Secondary outcome [11] 0 0
Adjusted Mean Change From Baseline in UPCR Over Time
Timepoint [11] 0 0
Day 365; Day 729, includes data up to July 1st 2017 when double-blind therapy ended
Secondary outcome [12] 0 0
Median Percent Change From Baseline in UPCR Over Time
Timepoint [12] 0 0
Day 365, Day 729
Secondary outcome [13] 0 0
Adjusted Mean Change From Baseline in eGFR Over Time
Timepoint [13] 0 0
Day 365, Day 729
Secondary outcome [14] 0 0
Median Time to First Sustained Change to No Response During the Double-blind Period
Timepoint [14] 0 0
Day 365, Day 729
Secondary outcome [15] 0 0
Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period
Timepoint [15] 0 0
Day 365, Day 729
Secondary outcome [16] 0 0
Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period
Timepoint [16] 0 0
Day 1 to Day 729; Day 365 to Day 729
Secondary outcome [17] 0 0
Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion
Timepoint [17] 0 0
Days 1 to 365
Secondary outcome [18] 0 0
Cmax: Maximum Observed Serum Concentration Following Participants Receiving Active Abatacept IV
Timepoint [18] 0 0
at 1 hour post Day 1 dose and 30 minutes post Day 337 dose
Secondary outcome [19] 0 0
AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval
Timepoint [19] 0 0
Days 337 to 365
Secondary outcome [20] 0 0
Summary Statistics for Systolic Blood Pressure
Timepoint [20] 0 0
Day 1 to Day 729
Secondary outcome [21] 0 0
Summary Statistics for Diastolic Blood Pressure
Timepoint [21] 0 0
Day 1 to Day 729
Secondary outcome [22] 0 0
Summary Statistics for Heart Rate
Timepoint [22] 0 0
Day 1 to Day 729
Secondary outcome [23] 0 0
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (U/L)
Timepoint [23] 0 0
Day 729
Secondary outcome [24] 0 0
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (g/L)
Timepoint [24] 0 0
Day 729
Secondary outcome [25] 0 0
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Percentage of Blood)
Timepoint [25] 0 0
Day 729
Secondary outcome [26] 0 0
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (Umol/L)
Timepoint [26] 0 0
Day 729
Secondary outcome [27] 0 0
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (mmol/L)
Timepoint [27] 0 0
Day 729
Secondary outcome [28] 0 0
Mean Change From Baseline in Laboratory Analytes During the Double-blind Period (x10^9 Cells/L)
Timepoint [28] 0 0
Day 729
Secondary outcome [29] 0 0
Number of Participants With Marked Hematology Laboratory Abnormalities During Year 1 of the Double Blind Period
Timepoint [29] 0 0
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
Secondary outcome [30] 0 0
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During Year 1 of the Double Blind Period
Timepoint [30] 0 0
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
Secondary outcome [31] 0 0
Number of Participants With Marked Electrolyte Laboratory Abnormalities During Year 1 of the Double Blind Period
Timepoint [31] 0 0
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
Secondary outcome [32] 0 0
Number of Participants With Marked Urinalysis Laboratory Abnormalities During Year 1 of the Double Blind Period
Timepoint [32] 0 0
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
Secondary outcome [33] 0 0
Number of Participants With Other Marked Chemistry Laboratory Abnormalities During Year 1 of the Double Blind Period
Timepoint [33] 0 0
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
Secondary outcome [34] 0 0
Number of Participants With Any Adverse Events (AEs) During Year 2 of the Double-blind Period and Long-term Extension
Timepoint [34] 0 0
From the first dose in Year 2 of the double-blind period up to 56 days post last dose
Secondary outcome [35] 0 0
Percentage of Participants in Treatment Failure Over Time During the Double-blind Period
Timepoint [35] 0 0
Day 365, Day 729
Secondary outcome [36] 0 0
Median Time to First Treatment Failure and Overall Treatment Failure During the Double-blind Period
Timepoint [36] 0 0
Day 365, Day 729
Secondary outcome [37] 0 0
Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 729 of the Double-blind Period
Timepoint [37] 0 0
Day 729
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
Timepoint [38] 0 0
Day 729
Secondary outcome [39] 0 0
Number of Participants With Marked Hematology Laboratory Abnormalities in the Double Blind Period
Timepoint [39] 0 0
Day 1 to Day 729
Secondary outcome [40] 0 0
Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities in the Double Blind Period
Timepoint [40] 0 0
Day 1 to Day 729
Secondary outcome [41] 0 0
Number of Participants With Marked Electrolyte Laboratory Abnormalities in the Double Blind Period
Timepoint [41] 0 0
Day 1 to Day 729
Secondary outcome [42] 0 0
Number of Participants With Marked Urinalysis Laboratory Abnormalities in the Double Blind Period
Timepoint [42] 0 0
Day 1 to Day 729
Secondary outcome [43] 0 0
Number of Participants With Other Marked Chemistry Laboratory Abnormalities in the Double Blind Period
Timepoint [43] 0 0
Day 1 to Day 729
Secondary outcome [44] 0 0
Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period
Timepoint [44] 0 0
Day 365, Day 729

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/05/2018
Sample size
Target
Accrual to date
Final
695
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Adelaide
Recruitment hospital [2] 0 0
Local Institution - Parkville
Recruitment hospital [3] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
6009 - Perth
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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State/province [3] 0 0
Connecticut
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Louisiana
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Massachusetts
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New Jersey
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New York
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North Carolina
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Ohio
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Tennessee
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Utah
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Virginia
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Argentina
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Buenos Aires
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Bahia
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Brazil
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Goias
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Sul
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Lucknow-
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Torino
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Gunma
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Daegu
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Lima
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San Juan
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj-napoca
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Iasi
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Russian Federation
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Moscow
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St. Petersburg
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Ufa
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Spain
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Madrid
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Taiwan
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Kaohsiung
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Taoyuan
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Turkey
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Antalya
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Turkey
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Edirne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

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)
Trial website
https://clinicaltrials.gov/study/NCT01714817
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01714817