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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224848
Enrollment
505
Registered
2019-08-28
Start date
2019-10-01
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

Interventions

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

Sponsors

Taisho Pharmaceutical Co.Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria: Subjects who had serious adverse drug reactions in the previous study. At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events. etc.

Design outcomes

Primary

MeasureTime frame
safety efficacy ACR20 adverse event,Side effects etc.

Secondary

MeasureTime frame
other -

Countries

Japan

Outcome results

None listed

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