drugset / Trial / NCT01021735
Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy
Phase 4
Completed
302 enrolled
University of Glasgow
Arthritis Research UK · collabNHS Borders · collabNHS Fife · collabNHS Grampian · collabNHS Lothian · collabNHS Tayside · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
That anti-TNF therapy and rituximab therapy are equally effective in treating patients with rheumatoid arthritis who meet the eligibility criteria for biologic therapy in the British Society for Rheumatology guidelines, and have not previously been exposed to biologic therapy.
Timeline
- Start
- 2010-04
- Primary completion
- 2014-12
- Completion
- 2015-04
Outcome
Met primary endpoint
paper with a difference within the prespecified non-inferiority margin of -0.19 (95% CI -0.51 to 0.13; p=0.24). PMID 27197690 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Comparator | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | Rituximab | Monoclonal antibody | 1 g | Intravenous |