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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 is a Phase 4 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 96 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01283971
The ClinicalTrials.gov registry entry for NCT01283971 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 96 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 5 interventions - of which methotrexate is the first listed.
NCT01283971 reports 0 study locations.
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.
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