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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: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00106535 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,196 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease
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 |
What the finished NCT00106535 record still lists
NCT00106535 is an interventional study that assigns participants to a tested intervention. Its 1,196 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00106535 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00106535's enrollment target sits among peer trials
1,196 228th of 2000 higher than 1,772 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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