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NCT00137969 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
A Phase 2 study of Lupus Erythematosus, Systemic, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 262
- Enrollment target
- 20
- Study locations
NCT00137969: Completed Phase 2 study of Lupus Erythematosus, Systemic, sponsored by Genentech.
NCT00137969 is a Phase 2 study of Lupus Erythematosus, Systemic that has completed, run by Genentech. The registered enrollment target is 262 participants, above the 194-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (35% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00137969, a Phase 2 study of Lupus Erythematosus, Systemic, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 262 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR =
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 |
What the finished NCT00137969 record still lists
NCT00137969 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, above the 194-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (35% higher).
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.
NCT00137969 names 20 study sites across 10 states, led by California, Illinois, Alabama.
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.
What interventions are being tested in trial NCT00137969?
The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Rituximab (DRUG), Prednisone (DRUG), Diphenhydramine (DRUG).
Who is sponsoring clinical trial NCT00137969?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT00137969's enrollment target sits among peer trials
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