drugset / Trial / NCT02393378

Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate

NCT02393378

Phase 2 Terminated 7 enrolled Takeda
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of namilumab in combination with existing methotrexate (MTX) therapy over 24 weeks in participants with moderate to severe early rheumatoid arthritis (RA), diagnosed within 6 months and inadequately controlled by MTX alone.

Timeline

Start
2015-04-08
Primary completion
2016-06-27
Completion
2016-11-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Comparator Namilumab Monoclonal antibody 150 mg Subcutaneous
Background Methotrexate Small molecule
Background folic acid Other / unclassified

Indications