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

Taisho Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: TS-152

Study type: Interventional

Funder types: Industry

Identifiers

NCT04077567

TS152-3002-JA

Details and patient eligibility

About

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).

Enrollment: 401 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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401 participants in 2 patient groups

TS-152 30mg SC

Experimental group

Description:

TS-152 30mg subcutaneously (SC) every 4 weeks

Treatment:

Drug: TS-152

TS-152 80mg SC

Experimental group

Description:

TS-152 80mg subcutaneously (SC) every 4 weeks

Treatment:

Drug: TS-152