Overview

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Status:
Terminated
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
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 mycophenolate mofetil (MMF) and corticosteroids.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Abatacept
Mycophenolate mofetil
Mycophenolic Acid
Prednisolone
Prednisone
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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