Rheumatoid Arthritis Clinical Trial
Official title:
An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis
Verified date | May 2023 |
Source | Taisho Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 401 |
Est. completion date | April 28, 2023 |
Est. primary completion date | April 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: 1. At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself. 2. 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: 1. Subjects who had serious adverse drug reactions in the previous study. 2. At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events. etc. |
Country | Name | City | State |
---|---|---|---|
Japan | Taisho Pharmaceutical Co., Ltd selected site | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Taisho Pharmaceutical Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events | 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. | through study completion, an average of 3 year | |
Primary | ACR20 | 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). | through study completion, an average of 3 year |
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