Status:
TERMINATED
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophe...
Detailed Description
Double Blind Period: Treatment, Parallel Assignment, Double Blind (Subject, Investigator), Randomized, Active Control, Safety/Efficacy Study Open Label Period: Prevention, Single Group Assignment, Op...
Eligibility Criteria
Inclusion
- Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry
- Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria \[2003\], excluding Class III \[C\], IV-S \[C\] and IV-G \[C\], or the World Health Organization Class III or IV classification criteria \[1982\], excluding Class IIIc, IVd). If the renal biopsy was performed \>3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA \>upper limit of normal range.
- A stable serum creatinine ≤3 mg/dL
Exclusion
- Subjects with a rise in serum creatinine of ≥1 mg/dL within 1 month prior to the screening visit
- Subjects with drug-induced SLE, as opposed to idiopathic SLE
- Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus
- Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis \[MS\])
- Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
- Subjects who have received treatment with rituximab \< 6 months prior to the screening visit
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT00430677
Start Date
June 1 2007
End Date
August 1 2011
Last Update
March 20 2015
Active Locations (84)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Arthritis Center
Tucson, Arizona, United States, 85724
3
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
4
University Of Kansas Medical Center
Kansas City, Kansas, United States, 66160