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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: TS-152

• 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

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-04
• Study Start: 2019-10-01
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2023-05
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

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

• 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.

Trial Locations

Locations (1)

Taisho Pharmaceutical Co., Ltd selected site; 🇯🇵 Tokyo, Japan