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NCT00106574 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,220
- Enrollment target
NCT00106574 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,220 participants.
The verdict
NCT00106574, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,220 participants
- Enrollment target
Study Summary
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
- DRUG Placebo
- DRUG tocilizumab [RoActemra/Actemra]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,220 participants |
| Start Date | 2005-04 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106574
The ClinicalTrials.gov registry entry for NCT00106574 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,220 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 2 interventions - of which Placebo is the first listed.
NCT00106574 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00106574 about?
NCT00106574 is a clinical study titled "A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis". This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had...
What is the current status of trial NCT00106574?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,220 participants. The study started on 2005-04. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00106574?
The interventions under investigation include: Placebo (DRUG), tocilizumab [RoActemra/Actemra] (DRUG).
Who is sponsoring clinical trial NCT00106574?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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