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NCT01119859 · ClinicalTrials.gov registry record · Phase 4
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 326
- Enrollment target
NCT01119859 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 326 participants.
The verdict
NCT01119859, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 326 participants
- Enrollment target
Study Summary
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.
Interventions
- DRUG Adalimumab
- DRUG Tocilizumab
- DRUG Placebo to tocilizumab
- DRUG Placebo to adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01119859
The ClinicalTrials.gov registry entry for NCT01119859 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 326 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 4 interventions - of which Adalimumab is the first listed.
NCT01119859 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01119859 about?
NCT01119859 is a clinical study titled "A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis". This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Pat...
What is the current status of trial NCT01119859?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 326 participants. The study started on 2010-05. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01119859?
The interventions under investigation include: Adalimumab (DRUG), Tocilizumab (DRUG), Placebo to tocilizumab (DRUG), Placebo to adalimumab (DRUG).
Who is sponsoring clinical trial NCT01119859?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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