Status:

COMPLETED

An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis

Lead Sponsor:

Taisho Pharmaceutical Co., Ltd.

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

20+ years

Phase:

PHASE3

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).

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 28 2023

Estimated Enrollment :

401 Patients enrolled

Trial Details

Trial ID

NCT04077567

Start Date

October 1 2019

End Date

April 28 2023

Last Update

February 28 2025

Active Locations (1)

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Taisho Pharmaceutical Co., Ltd selected site

Tokyo, Japan