NCT02722694

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

A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept 125mg Administered Subcutaneously in Chinese Subjects With Active Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	Subcutaneous(SC) Abatacept	Subjects received 125mg weekly SC abatacept injections for 24 weeks. All subjects who complete 24 weeks double-blind treatment are eligible to enter open label period. During this period, subjects in placebo group will be switched to receive abatacept 125mg administered SC weekly till week 52. Subjects in abatacept group will continue to receive abatacept 125mg weekly.
OTHER	Placebo	Subjects received weekly SC placebo injections for 24 weeks
DRUG	Methotrexate	All Subjects received backup Methotrexate treatment.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2016-03-30
• Last updated: 2016-09-13

Locations

1 site across 1 country: China