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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proportion of subjects achieving Complete Response of renal disease following 52 weeks of treatment, where complete response is a composite endpoint based on renal function, proteinuria, urine sediment, and corticosteroid dose
At Day 365
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Institutional Review Board
IM101-291
NCT01714817
February 2013
July 2019
Name | Location |
---|---|
Emory University | Atlanta, Georgia 30322 |
Local Institution | Bronx, New York |
Local Institution | Corona, California |
Local Institution | Fort Lauderdale, Florida |
Local Institution | Springfield, Massachusetts |
Local Institution | Wilmington, North Carolina |
Local Institution | Austin, Texas |
Local Institution | New Orleans, Louisiana |
Local Institution | Salt Lake City, Utah |
University of Alabama at Birmingham (UAB) | Birmingham, Alabama 35233 |
Northshore Lij Health System | Lake Success, New York 11042 |
The Feinstein Institute For Medical Research | Manhasset, New York 11030 |
Shanahan Rheum & Immunology Pllc | Raleigh, North Carolina 27617 |
Paramount Medical Research & Consulting, Llc | Middleburg Heights, Ohio 44130 |
Rheumatology Consultants Pllc | Knoxville, Tennessee 37909-1907 |