drugset / Trial / NCT02379091

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

NCT02379091

Phase 2 Completed 108 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to establish proof of concept and identify the optimal efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor (TNF)-inhibitor (TNF-IR).

Timeline

Start
2014-12-17
Primary completion
2016-05-11
Completion
2016-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Namilumab Monoclonal antibody 20 mg Subcutaneous
Subject Namilumab Monoclonal antibody 80 mg Subcutaneous
Subject Namilumab Monoclonal antibody 150 mg Subcutaneous
Background Folic/folinic acid Unknown Oral
Background Methotrexate Small molecule Oral

Indications