This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Number of Participants With Major Clinical Response (MCR)
Time frame: Week 48
Number of Participants With Partial Clinical Response (PCR)
Time frame: Week 48
Number of Non-responders (NR)
Time frame: Week 48
Number of Participants Who Achieved a BILAG Score of C or Better at Week 24.
Time frame: Week 24
Time Adjusted Mean SLEDAI-2K Score
Time frame: Week 48
Annualized Flare Rate
Time frame: Week 48 to Week 96
Time to First Moderate to Severe Flare
Time frame: Week 48 to Week 96
Number of Participants Who Achieved A Major Or Partial Clinical Response At Week 48 (PCR Plus MCR Proportion), Who Did Not Experience A Flare Before Week 96
Time frame: Week 48 to Week 96
Number of Participants Who Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 72
Time frame: Week 48 to Week 72
Number of Participants Achieved A MCR At Week 48, Who Did Not Experience A Flare Before Week 96
Time frame: Week 48 to Week 96
Change in SF-36 Subscale And Summary Scores From Baseline At Week 48
Time frame: Baseline, Week 48
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Intravenous repeating dose
Intravenous repeating dose
Change In FACIT-Fatigue Assessment From Baseline To Week 48
Time frame: Baseline, Week 48
Change From Baseline In Pain Quality And Impact Of Pain On Daily Function Measured By The Brief Pain Inventory Short Form At Week 48
Time frame: Baseline, Week 48
The EQ-5D Single Index Utility Score At Week 48
Time frame: Baseline, Week 48
Number of Participants With Adverse Events
Time frame: Up to 2.5 years