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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 March 2025
• Main ID: NCT04077567
• Date of registration: 29/08/2019
• Prospective Registration: Yes
• Primary sponsor: Taisho Pharmaceutical Co., Ltd.
• Public title: An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis
• Scientific title: An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis
• Date of first enrolment: October 1, 2019
• Target sample size: 401
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04077567
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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.


Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: TS-152

Primary Outcome(s)

Incidence of adverse events [Time Frame: through study completion, an average of 3 year]

ACR20 [Time Frame: through study completion, an average of 3 year]

Secondary ID(s)

TS152-3002-JA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors