drugset
drugset / Trial / NCT02990806

A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE)

NCT02990806 ↗

Phase 3 Completed 683 enrolled Nichi-Iko Pharmaceutical Co., Ltd.
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study was to demonstrate similarity of NI-071 (proposed biosimilar to infliximab) to US REMICADE® (reference product) in terms of safety and efficacy in participants with rheumatoid arthritis (RA) not adequately responding to methotrexate (MTX).

Timeline

Start
2017-01-19
Primary completion
2019-05-20
Completion
2019-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 3 mg/kg Intravenous
Subject NI-071 Unknown 3 mg/kg Intravenous

Indications

rheumatoid arthritis