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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: Completed Phase 4 study, sponsored by Hoffmann-La Roche.
NCT01119859 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 326 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hou
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 |
What the finished NCT01119859 record still lists
NCT01119859 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 4 interventions - of which Adalimumab is the first listed.
NCT01119859 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01119859's enrollment target sits among peer trials
326 253rd of 2000 higher than 1,747 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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