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NCT02097745 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 341
- Enrollment target
NCT02097745: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02097745 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 341 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02097745, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 341 participants
- Enrollment target
Study Summary
This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.
Primary Outcome
A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity \[symptom-free and no arthritis symptoms\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS
Interventions
- DRUG methotrexate
- DRUG rituximab [MabThera/Rituxan]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 341 participants |
| Start Date | 2004-06 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT02097745 record still lists
NCT02097745 is an interventional study that assigns participants to a tested intervention. The registered 341 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which methotrexate is the first listed.
NCT02097745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02097745 about?
NCT02097745 is a clinical study titled "A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies". This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local ma...
What is the current status of trial NCT02097745?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 341 participants. The study started on 2004-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT02097745?
The interventions under investigation include: methotrexate (DRUG), rituximab [MabThera/Rituxan] (DRUG).
Who is sponsoring clinical trial NCT02097745?
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 NCT02097745's enrollment target sits among peer trials
341 1053rd of 2000 higher than 948 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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