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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04077567
Other study ID # TS152-3002-JA
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 1, 2019
Est. completion date April 28, 2023

Study information

Verified date May 2023
Source Taisho Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TS-152
30mg,80mg

Locations

Country Name City State
Japan Taisho Pharmaceutical Co., Ltd selected site Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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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