A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

Phase 2 Completed 379 enrolled Astellas Pharma Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of ASP015K in moderate to severe rheumatoid arthritis subjects who are methotrexate-inadequate responders (MTX-IR).

Timeline

Start: 2012-07-06
Primary completion: 2014-02-11
Completion: 2014-02-11

Outcome

Met primary endpoint

paper The ACR20 response rate in the group receiving peficitinib 50 mg plus MTX was significantly different compared with the rate in patients receiving placebo. PMID 27748083 ↗

Publications

Kivitz AJ, Gutierrez-Urena SR, Poiley J, Genovese MC, Kristy R, Shay K, Wang X, Garg JP, Zubrzycka-Sienkiewicz A. Peficitinib, a JAK Inhibitor, in the Treatment of Moderate-to-Severe Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate. Arthritis Rheumatol. 2017 Apr;69(4):709-719. doi: 10.1002/art.39955.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	peficitinib	Small molecule	25 mg	Oral
Subject	peficitinib	Small molecule	50 mg	Oral
Subject	peficitinib	Small molecule	100 mg	Oral
Subject	peficitinib	Small molecule	150 mg	Oral
Background	Methotrexate	Small molecule	—	Oral