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NCT00106522 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 499
- Enrollment target
NCT00106522 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 499 participants.
The verdict
NCT00106522, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 499 participants
- Enrollment target
Study Summary
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG tocilizumab [RoActemra/Actemra]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 499 participants |
| Start Date | 2005-05 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106522
The ClinicalTrials.gov registry entry for NCT00106522 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 499 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.
NCT00106522 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00106522 about?
NCT00106522 is a clinical study titled "A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy". This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate re...
What is the current status of trial NCT00106522?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 499 participants. The study started on 2005-05. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00106522?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), tocilizumab [RoActemra/Actemra] (DRUG).
Who is sponsoring clinical trial NCT00106522?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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