A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223971

Enrollment

370

Registered

2018-07-09

Start date

2018-09-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis (RA)

Interventions

investigational material(s) Generic name etc : TS-152 INN of investigational material : ozoralizumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients diagnosed with RA based on the American College of Rheumatology (ACR) 2010 revised criteria for classification of RA etc.

Exclusion criteria

Exclusion criteria: - Patients who are observed any abnormal findings suggestive of malignant tumor, infection, or interstitial pneumonia. - Patients with severe cardiovascular, hepatic, and/or renal diseases. etc.

Design outcomes

Primary

Measure	Time frame
efficacy safety ACR20, Modified Total Sharp Score (mTSS)	—

Secondary

Measure	Time frame
safety efficacy ACR50, ACR70, DAS28-CRP, DAS28-ESR etc.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026