Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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 mycophenolate mofetil (MMF) and corticosteroids.

Key facts

Study ID

NCT00430677

Run by

Bristol-Myers Squibb

People needed

423

Starts

2007-06-01

Expected to finish

2011-08-01

Last updated by the study team

2015-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Arthritis Center — Tucson, Arizona, United States
• Wallace Rheumatic Study Center — Los Angeles, California, United States
• University Of Kansas Medical Center — Kansas City, Kansas, United States
• Boston University School Of Medicine — Boston, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Suny Downstate Medical Center — Brooklyn, New York, United States
• Northshore Lij Health System — Lake Success, New York, United States
• The Feinstein Institute For Medical Research — Manhasset, New York, United States
• Suny Upstate Medical University — Syracuse, New York, United States
• University Of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States
• Ok Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Rheumatology Consultants Pllc — Knoxville, Tennessee, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Local Institution — Capital Federal, Buenos Aires, Argentina
• Local Institution — Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
• Local Institution — Córdoba, Córdoba Province, Argentina
• Local Institution — San Miguel de Tucumán, Tucumán Province, Argentina
• Local Institution — Liverpool, New South Wales, Australia
• Local Institution — Clayton, Victoria, Australia
• Local Institution — Heidelberg, Victoria, Australia
• Local Institution — Parkville, Victoria, Australia
• Local Institution — Brussels, Belgium
• Local Institution — Leuven, Belgium
• Local Institution — Goiânia, Goiás, Brazil
• University Of Alabama At Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.