A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Genentech, Inc.
- Study ID
- NCT00137969
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
- Lupus Erythematosus, Systemic
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUGRituximab will be supplied as a sterile liquid for IV administration.
- Placebo — DRUGPlacebo will be supplied as a sterile liquid for IV administration.
- Prednisone — DRUG
- Acetaminophen — DRUG
- Diphenhydramine — DRUG
Study Details
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.
Key Dates
- Start date
- May 10, 2005
- Status verified
- Jun 2017
- Primary completion
- Aug 25, 2008
- Completion
- Aug 25, 2008
Study Design
- Enrollment
- 262 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Rituximab 1000 mg + prednisoneParticipants will receive rituximab 1000 mg intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
- Placebo Comparator: Placebo + prednisoneParticipants will receive placebo intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Primary Outcome Measure
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period [ Time Frame: From baseline to 52 weeks ]
Locations (63)
Find similar trials in Birmingham, AL
By research site
Univ of Alabama School of Med; Clinical Immun Rheumatology· Birmingham, ALRheumatology Assoc of North AL· Huntsville, ALArizona Arthritis & Rheumatology Research, Pllc· Paradise Valley, AZUniv of California, San Diego· La Jolla, CACedars-Sinai Medical Center· Los Angeles, CAUniv of Calif., Los Angeles; Rheumatology· Los Angeles, CA
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