drugset / Trial / NCT01021735

Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy

NCT01021735 ↗

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

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Comparator Etanercept Protein / enzyme biologic 50 mg Subcutaneous
Subject Rituximab Monoclonal antibody 1 g Intravenous

Indications