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A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
NCT00137969 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Acetaminophen
- DRUG Rituximab
- DRUG Prednisone
- DRUG Diphenhydramine
Study Locations (20)
California
- Univ of California, San Diego — La Jolla
- Univ of Calif., Los Angeles; Rheumatology — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
- Stanford University Med Ctr;Div of Immunology/Rheumatology — Palo Alto
- Univ of Calif, San Francisco; Rheumatology — San Francisco
- Eden Medical Center San Leandro Hospital — San Leandro
Illinois
- Northwestern University — Chicago
- Rheumatology Associates — Chicago
- University of Chicago — Chicago
Alabama
- Univ of Alabama School of Med; Clinical Immun Rheumatology — Birmingham
- Rheumatology Assoc of North AL — Huntsville
Florida
- Arthritis & Rheumatism; Disease Specialities — Aventura
- Family Arthritis Center — Jupiter
Idaho
- Intermountain Research Center — Boise
- Coeur D'Alene Arthritis Clinic — Coeur d'Alene
Arizona
- Arizona Arthritis & Rheumatology Research, Pllc — Paradise Valley
Colorado
- University of Colorado Denver — Aurora
Georgia
- Emory Uni ; Division of Rheumatology — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2005-05-10 |
| Est. Completion | 2008-08-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00137969
The ClinicalTrials.gov registry entry for NCT00137969 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 262 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 206 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00137969 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Illinois, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00137969 about?
NCT00137969 is a clinical study titled "A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus". 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 (...
What is the current status of trial NCT00137969?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 262 participants. The study started on 2005-05-10. Estimated completion is 2008-08-25.
What conditions does trial NCT00137969 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00137969?
The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Rituximab (DRUG), Prednisone (DRUG), Diphenhydramine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00137969?
This trial is sponsored by Genentech, which has 206 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00137969 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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