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NCT00282308 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT00282308: Completed Phase 2 study, sponsored by Genentech.
NCT00282308 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00282308, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).
Primary Outcome
The immune response to tetanus toxoid adsorbed booster vaccine was measured in serum samples immediately prior to and 4 weeks after vaccine administration. The tetanus antibody test was an ELISA that used tetanus toxoid as a capturing reagent and alkaline phosphatase-conjugated anti-human IgG (γ) for detection. For patients with pre-vaccination tetanus antibody titers \< 0.1 IU/mL, a positive immune response was defined as an antibody titer ≥ 0.2 IU/mL. For patients with pre-vaccination tetanus
Interventions
- DRUG Rituximab
- DRUG Methotrexate
- DRUG Methylprednisone
- BIOLOGICAL C. albicans
- BIOLOGICAL Tetanus toxoid adsorbed booster vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2006-01-23 |
| Est. Completion | 2012-05-28 |
| Phase | Phase 2 |
What the finished NCT00282308 record still lists
NCT00282308 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT00282308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00282308 about?
NCT00282308 is a clinical study titled "A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate". This was a Phase II, randomized, open-label, multicenter study designed to evaluate the immune response to vaccines after administration of 1000 mg of rituximab in subjects with active rheumatoid arthritis (RA) who were receiving background methotrexate (MTX).
What is the current status of trial NCT00282308?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2006-01-23. Estimated completion is 2012-05-28.
What interventions are being tested in trial NCT00282308?
The interventions under investigation include: Rituximab (DRUG), Methotrexate (DRUG), Methylprednisone (DRUG), C. albicans (BIOLOGICAL), Tetanus toxoid adsorbed booster vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00282308?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00282308's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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