drugset

drugset / Trial / NCT00547521

Phase IIIB Subcutaneous Abatacept Monotherapy Study

NCT00547521 ↗

Phase 3 Completed 119 enrolled Bristol-Myers Squibb

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept

Timeline

Start: 2007-12
Primary completion: 2008-12
Completion: 2014-02

Publications

Nash P, Nayiager S, Genovese MC, Kivitz AJ, Oelke K, Ludivico C, Palmer W, Rodriguez C, Delaet I, Elegbe A, Corbo M. Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label study. Arthritis Care Res (Hoboken). 2013 May;65(5):718-28. doi: 10.1002/acr.21876.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	125 mg/kg	Subcutaneous
Subject	Methotrexate	Small molecule	10 mg	—

Indications