NCT01554696

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

A Phase 2b, Randomized, Double-blind, Parallel-group, Placebo Controlled, Dose-finding, Multi-center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis in Patients Who Have Had an Inadequate Response to Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 379 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Subjects in each treatment group will continue to take their concomitant oral weekly dose of methotrexate (MTX) in addition to daily ASP015K or matching placebo, taken orally with food, daily for 12 weeks after randomization.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	peficitinib	oral
DRUG	Placebo	oral
DRUG	methotrexate	oral

Timeline

• Start date: 2012-07-06
• Primary completion: 2014-02-11
• Completion: 2014-02-11
• First posted: 2012-03-15
• Last updated: 2025-05-29

Locations

49 sites across 8 countries: United States, Belgium, Bulgaria, Colombia, Czechia, Hungary, Mexico, Poland