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
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
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)
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
Inclusion Criteria:
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:
Inclusion Criteria for the Long-Term Extension Period:
Exclusion Criteria:
Capital Federal, Buenos Aires 1015, Argentina
Capital Federal, Buenos Aires 1431, Argentina
Savaldor, Estado de Bahia 40150-150, Brazil
Wuhan, Hebei 430030, China
Bogota, Cundinamarca, Colombia
Secunderabad, Andhra Pradesh 500003, India
Nagakute-shi, Aichi-ken 4801195, Japan
Kitakyushu-shi, Fukuoka 8078555, Japan
Iruma-gun, Saitama 3500495, Japan
Shimotsuke-shi, Tochigi 3290498, Japan
Bunkyo-ku, Tokyo 1138431, Japan
Bunkyo-ku, Tokyo 1138519, Japan
Chuo-ku, Tokyo 1048560, Japan
Shinjuku-Ku, Tokyo 1608582, Japan
Kita-gun, 7610793, Japan
Guadalajara, Jalisco, Jalisco 44160, Mexico