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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2023-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.

NCT03605251

Rheumatoid Arthritis

COMPLETED PHASE2

A Study of TJ003234 in Rheumatoid Arthritis Patients

NCT04457856

Rheumatoid Arthritis

UNKNOWN PHASE1

Study of MRA in Patients With Rheumatoid Arthritis (RA)

NCT00144651

Rheumatoid Arthritis

COMPLETED PHASE2

Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis

NCT05572567

Arthritis, Rheumatoid

COMPLETED

PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

NCT00380601

Rheumatoid Arthritis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TS-152 30mg SC

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

Group Type EXPERIMENTAL

TS-152

Intervention Type DRUG

30mg,80mg

TS-152 80mg SC

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

Group Type EXPERIMENTAL

TS-152

Intervention Type DRUG

30mg,80mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TS-152

30mg,80mg

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ozoralizumab

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No