An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
- Registration Number
- NCT04077567
- Lead Sponsor
- Taisho Pharmaceutical Co., Ltd.
- Brief Summary
To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
Inclusion Criteria
- At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself.
- At Visit2(0 week), Subjects must have completed the previous study (TS152-3000-JA or TS152-3001-JA) ,and must have completed all evaluations required at the follow-up visit.
etc.
Exclusion Criteria
- Subjects who had serious adverse drug reactions in the previous study.
- At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events.
etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TS-152 80mg SC TS-152 TS-152 80mg subcutaneously (SC) every 4 weeks TS-152 30mg SC TS-152 TS-152 30mg subcutaneously (SC) every 4 weeks
- Primary Outcome Measures
Name Time Method ACR20 through study completion, an average of 3 year Percentage of Subjects who meet the American College of Rheumatology 20% (ACR20) Criteria from baseline of previous study (TS152-3001-JA or TS152-3001-JA).
Incidence of adverse events through study completion, an average of 3 year To evaluate the Long-term safety of TS-152 in RA patients by incidence of adverse events which include vital signs, and clinical laboratory parameters.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taisho Pharmaceutical Co., Ltd selected site
🇯🇵Tokyo, Japan