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NCT01283971 · ClinicalTrials.gov registry record · Phase 4
A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor
A Phase 4 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 4
- Development phase
- 96
- Enrollment target
NCT01283971: Clinical Trial Phase 4 study, sponsored by Hoffmann-La Roche.
NCT01283971 is a Phase 4 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 96 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01283971, a Phase 4 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 96 participants
- Enrollment target
Study Summary
This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.
Primary Outcome
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 2 to 10. DAS28 Remission is defined as a DAS28 score \<2.6.
Interventions
- DRUG methotrexate
- DRUG tocilizumab [RoActemra/Actemra]
- DRUG adalimumab
- DRUG placebo to tocilizumab
- DRUG placebo to adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
Why NCT01283971 stopped before completion
NCT01283971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 5 interventions - of which methotrexate is the first listed.
NCT01283971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01283971 about?
NCT01283971 is a clinical study titled "A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor". This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be ran...
What is the current status of trial NCT01283971?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 96 participants. The study started on 2011-05. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01283971?
The interventions under investigation include: methotrexate (DRUG), tocilizumab [RoActemra/Actemra] (DRUG), adalimumab (DRUG), placebo to tocilizumab (DRUG), placebo to adalimumab (DRUG).
Who is sponsoring clinical trial NCT01283971?
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 NCT01283971's enrollment target sits among peer trials
96 863rd of 2000 higher than 1,132 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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