A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

Phase 3 Completed 217 enrolled Bristol-Myers Squibb

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate the safety of chronic use of abatacept in Japanese Subjects with Rheumatoid Arthritis (RA) having completed clinical studies IM101-071, IM101-034, and also Disease Modifying Anti-Rheumatic Drugs (DMARDs) failures with MTX intolerance.

Timeline

Start: 2006-12
Primary completion: 2010-12
Completion: 2010-12

Publications

Takeuchi T, Matsubara T, Urata Y, Suematsu E, Ohta S, Honjo S, Abe T, Yamamoto A, Miyasaka N; Japan Abatacept Study Group. Phase III, multicenter, open-label, long-term study of the safety of abatacept in Japanese patients with rheumatoid arthritis and an inadequate response to conventional or biologic disease-modifying antirheumatic drugs. Mod Rheumatol. 2014 Sep;24(5):744-53. doi: 10.3109/14397595.2014.899179. Epub 2014 Apr 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	500 mg	Intravenous
Subject	Abatacept	Other / unclassified	750 mg	Intravenous
Subject	Abatacept	Other / unclassified	1000 mg	Intravenous

A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

Summary

Timeline

Publications

Drugs

Indications