drugset / Trial / NCT03016013

A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects with Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.

NCT03016013

Phase 3 Completed 479 enrolled RemeGen Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to initially access the safety and effectivity of RC18 combined with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with moderate to severe Rheumatoid Arthritis (RA) who have an inadequate response to MTX therapy.

Timeline

Start
2017-03-29
Primary completion
2022-11-19
Completion
2022-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Telitacicept Protein / enzyme biologic 160 mg Subcutaneous
Comparator MTX=Methotrexate Unknown Subcutaneous
Background MTX=Methotrexate Unknown Subcutaneous

Indications