Arthritis, Rheumatoid Clinical Trial
Official title:
Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K
This study evaluated the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.
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. ;
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