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01
Overview
Phase 3, randomised, double-blind trial in systemic lupus erythematosus (SLE) comparing Rituximab + Prednisone with Placebo + Prednisone (2 arms). Primary endpoint: Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) by BILAG Scores at 52 weeks. Started May 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Rituximab + Prednisone
Rituximab 1000 mg IV + Prednisone taper + Background Immunosuppressant
Placebo + Prednisone
Placebo IV + Prednisone taper + Background Immunosuppressant
03
Who it enrols
Patients with moderate to severe SLE (active disease at screening) on stable use of one immunosuppressive drug and an antimalarial drug.
04
Endpoints
Primary
Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) by BILAG Scores
Secondary
Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score
Number of Participants Who Achieved a Major Clinical Response (MCR)
Number of Participants Who Achieved a Partial Clinical Response (PCR)
Number of Participants Who Achieved a BILAG C or Better in All Domains
Time to First Moderate or Severe Flare
Change in SLE Expanded Health Survey Physical Function Score
05
Results
Not all primary endpoints met
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