NCT01711814

A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 611 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study.

Detailed description

This study is comprised of a 104 week treatment period beginning on Day 1 of study drug administration and a 30-day follow-up period or permanent termination of clinical development of the product, whichever is earlier.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	peficitinib	oral

Timeline

• Start date: 2012-09-26
• Primary completion: 2016-03-25
• Completion: 2016-03-25
• First posted: 2012-10-22
• Last updated: 2024-10-21

Locations

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