drugset / Trial / NCT01162421

A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis

NCT01162421 ↗

Phase 4 Completed 77 enrolled AbbVie Mount Sinai Hospital, Canada · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.

Timeline

Start
2010-09
Primary completion
2015-07
Completion
2015-07

Outcome

Missed primary endpoint

registry Standard of Care vs Early Adalimumab; p = 0.907; Difference in percentage -1.3 (95% CI -23.4 to 20.8); Chi-squared NCT01162421 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Background Methotrexate Small molecule — —

Indications