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NCT02093026 · ClinicalTrials.gov registry record · Phase 2
Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 465
- Enrollment target
NCT02093026: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT02093026 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 465 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (250% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02093026, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 465 participants
- Enrollment target
Study Summary
This study will assess the long-term safety and efficacy of repeat treatment courses of rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug (DMARD) inadequate responder population of participants who were previously randomized into studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple re-treatments until the protocol-defined end-of-treatment date (31 December 2011). Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will provide at least 7 years follow-up data on all participants initially randomized into WA16291 or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this open label extension study from their respective feeder studies.
Primary Outcome
A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in tender joint count (TJC) and swollen joint count (SJC) (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3
Interventions
- DRUG Rituximab
- DRUG Methylprednisolone
- DRUG Methotrexate
- DRUG Folic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2002-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT02093026 record still lists
NCT02093026 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (250% higher).
The record links to 0 conditions, and to 4 interventions - of which Rituximab is the first listed.
NCT02093026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02093026 about?
NCT02093026 is a clinical study titled "Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)". This study will assess the long-term safety and efficacy of repeat treatment courses of rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug (DMARD) inadequate responder population of participants who were previously randomized into studies WA16291 (NCT02693210) or ...
What is the current status of trial NCT02093026?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 465 participants. The study started on 2002-08. Estimated completion is 2012-12.
What interventions are being tested in trial NCT02093026?
The interventions under investigation include: Rituximab (DRUG), Methylprednisolone (DRUG), Methotrexate (DRUG), Folic Acid (DRUG).
Who is sponsoring clinical trial NCT02093026?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02093026's enrollment target sits among peer trials
465 80th of 2000 higher than 1,920 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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