Abatacept With Methotrexate- Phase IIB

Phase 2 Completed 524 enrolled Bristol-Myers Squibb

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.

Timeline

Start: 2000-10
Primary completion: 2009-09
Completion: 2009-09

Outcome

Met primary endpoint

registry DB Abatacept 10 mg/kg + Methotrexate vs DB Placebo + Methotrexate; p <0.001; Point Estimate of Difference 25.6 NCT00162266 ↗

Publications

Westhovens R, Kremer JM, Emery P, Russell AS, Alten R, Barre E, Dougados M. Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):553-62. Epub 2014 Jul 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	2 mg/kg	Intravenous
Subject	Abatacept	Other / unclassified	10 mg/kg	Intravenous