drugset / Trial / NCT02722694

A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

NCT02722694

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to demonstrate superior efficacy of abatacept 125mg administrated SC weekly comparing to placebo after 24 weeks treatment in Chinese subjects who have active rheumatoid arthritis, are receiving methotrexate and experiencing an inadequate response to methotrexate. This will be estimated by the proportion of subjects meeting the American College of Rheumatology (ACR) criteria for 20% improvement (ACR20).

Timeline

Start
2016-08
Primary completion
2017-06
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 125 mg Subcutaneous
Background Methotrexate Small molecule

Indications