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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 465 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02093026
The ClinicalTrials.gov registry entry for NCT02093026 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 465 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Rituximab is the first listed.
NCT02093026 reports 0 study locations.
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.
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