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RGB-19 Phase III Clinical Study

RGB-19 Phase III Clinical Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031220512
Enrollment
358
Registered
2022-12-15
Start date
2023-01-16
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

Active Rheumatoid Arthritis

Interventions

RGB-19 or Tocilizumab

Sponsors

Karibe Yusuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Male or Female patients from 20 years to 75 years of age (both inclusive) when signing Informed Consent. Active RA patients. Patients who have an inadequate response to MTX.

Exclusion criteria

Exclusion criteria: Patients who have received treatment with two or more biological DMARDs/their biosimilar products. Patients who have ever received tocilizumab, any other IL-6 inhibitors or IL-6 receptor inhibitors, or Janus kinase inhibitors in the past. Patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period.

Design outcomes

Primary

MeasureTime frame
Mean Change from baseline in DAS28-ESR at Week 12 after the first administration of investigational product

Contacts

Public ContactPublic Relations

Mochida Pharmaceutical Co., Ltd.

webmaster@mochida.co.jp+81-3-3225-6303

Outcome results

None listed

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