drugset / Trial / NCT03707535

To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

NCT03707535

Phase 3 Completed 270 enrolled Celltrion
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.

Timeline

Start
2018-11-12
Primary completion
2020-03-16
Completion
2021-03-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Infliximab Monoclonal antibody 3 mg/kg

Indications