A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids

IRB Number: 27089

Institutional Review Board, Hospital for Special Surgery

December 12, 2007

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Kyriakos A. Kirou, MD, FACR

Co-Investigators

Stephen Dimartino, MD
Jessica Berman, MD

Summary

The purpose of this study is to see if abatacept is better than placebo (inactive substance) on a background of Mycophenolate Mofetil and Glucocorticoids for the treatment of lupus nephritis.  Intravenous abatacept has been approved in the United States for the treatment of moderate to severe rheumatoid arthritis (RA) . 
If you are enrolled, your participation is expected to be 12 months, with the possibility of enrollment into an additional extension phase after that. Mycophenolate Mofetil will be provided. This extension study phase will continue until abatacept is marketed for lupus nephritis in your country or until the sponsor stops the study.  Some study participants will receive placebo.

Inclusion/Exclusion Criteria

Eligible patients include males and females >= 16 year old with systemic lupus erythematosus (SLE) who have active proliferative lupus nephritis.

Inclusion Criteria:

  • 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 6 months of enrollment (screening visit) indicating active proliferative lupus glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III (C), IV-S (C) and IV-g (C)]. If renal function has deteriorated, biopsy may have been no more than 3 months prior to enrollment (screening visit)
  • Active renal disease at the screening visit, as defined by: urinary protein/creatinine ratio >=0.5 AND an active urinary sediment as defined by at least one of the following 3 criteria: i) >5 RBC/hpf OR ii) >5 WBC/hpf (with no evidence of a urinary tract infection) OR iii) cylindruria AND
  • A Stable serum creatine <=3 mg/dL

Exclusion Criteria:

  • Subjects with a rise in serum creatine 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 CNS lupus
  • Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; RA, MS)
  • Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
  • Subjects who have received treatment with rituximab within 1 year of screening visit or who have persisting lymphopenia following rituximab at anytime in the past

Contact Information

Roland Duculan
212.774.2967
duculanr@hss.edu