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NCT00109408 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 673
- Enrollment target
NCT00109408: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT00109408 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 673 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00109408, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 673 participants
- Enrollment target
Study Summary
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Interventions
- DRUG Methotrexate
- DRUG tocilizumab [RoActemra/Actemra]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 673 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
What the finished NCT00109408 record still lists
NCT00109408 is an interventional study that assigns participants to a tested intervention. The registered 673 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 (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Methotrexate is the first listed.
NCT00109408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00109408 about?
NCT00109408 is a clinical study titled "A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis". This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv...
What is the current status of trial NCT00109408?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 673 participants. The study started on 2005-07. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00109408?
The interventions under investigation include: Methotrexate (DRUG), tocilizumab [RoActemra/Actemra] (DRUG).
Who is sponsoring clinical trial NCT00109408?
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 NCT00109408's enrollment target sits among peer trials
673 544th of 2000 higher than 1,457 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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