RGB-19 Phase III Clinical Study
Phase 3
Recruiting
- Conditions
- Active Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2031220512
- Lead Sponsor
- Watanabe Manabu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 358
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Change from baseline in DAS28-ESR at Week 12 after the first administration of investigational product
- Secondary Outcome Measures
Name Time Method