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

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

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

Summary

Timeline

Publications

Drugs

Indications