NCT01638013

A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 843 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.

Detailed description

This study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) participants who completed the Phase IIb Study of ASP015K \[015K-CL-RAJ1 (hereinafter referred to as study RAJ1)\], Phase III Study of ASP015K \[015K-CL-RAJ3 (RAJ3)\], or Phase III Study of ASP015K \[015K-CL-RAJ4 (RAJ4)\]. After the marketing approval in Japan on 26 Mar 2019, this study continued as "post marketing clinical study" in Japan. In Taiwan and Korea, this study continued as "clinical study". Participants received oral ASP015K once daily (QD) after breakfast. The ASP015K dose was increased later for participants who have no safety problems but showed lack of efficacy. The duration of treatment with the study drug was differed depending upon the participants.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Peficitinib	Oral Tablet

Timeline

• Start date: 2012-06-13
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2012-07-11
• Last updated: 2024-10-28
• Results posted: 2020-10-23

Locations

175 sites across 3 countries: Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study