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NCT00106535 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,196
- Enrollment target
NCT00106535 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,196 participants.
The verdict
NCT00106535, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,196 participants
- Enrollment target
Study Summary
This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG tocilizumab [RoActemra/Actemra]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,196 participants |
| Start Date | 2005-01 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106535
The ClinicalTrials.gov registry entry for NCT00106535 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,196 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 3 interventions - of which Placebo is the first listed.
NCT00106535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00106535 about?
NCT00106535 is a clinical study titled "A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)". This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be random...
What is the current status of trial NCT00106535?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,196 participants. The study started on 2005-01. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00106535?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), tocilizumab [RoActemra/Actemra] (DRUG).
Who is sponsoring clinical trial NCT00106535?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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