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 (MMF) and Corticosteroids in Subjects with Active Class III or IV Lupus...

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 (MMF) and Corticosteroids in Subjects with Active Class III or IV Lupus Nephritis IM101-291

Principal Investigator: Will Pendergraft, MD, PhD
Sponsor: Bristol Myers Squibb
Age Range: 16 and older
Status: Ongoing; not enrolling

Purpose: The primary objective of this study is to compare the proportion of subjects who achieve Complete Renal Response of lupus glomerulonephritis at Day 365 following 1 year of treatment with abatacept to the proportion of subjects who achieve Complete Renal Response after 1 year of receiving placebo. Both the abatacept and placebo will be administered on a background of MMF (cellcept) and corticosteroids. To qualify, patients must have had a renal biopsy within the past 12 months.

Study Procedures: Eligible participants will be randomized to either placebo or abatacept at 30 mg/kg administered intravenously on Days 1, 15, 29, and 57, followed by a weight-tiered fixed dose approximating 10 mg/kg administered every 28 days throughout the remainder of the Treatment Period. All subjects will also receive therapy with MMF and corticosteroids.

Participation: Patients will be expected to complete 32 study visits over a 2 year period. Visits will take approximately 3 hours.

For more information, please contact:

Brenda Meier
919-445-2730                                      

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