RGB-19 Phase III Clinical Study

JRCT ID: jRCT2031220512

Registered date:15/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Active Rheumatoid Arthritis
• Date of first enrollment: 01/01/2023
• Target sample size: 358
• Study type: Interventional
• Intervention(s): RGB-19 or Tocilizumab

Outcome(s)

• Primary Outcome: Mean Change from baseline in DAS28-ESR at Week 12 after the first administration of investigational product

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Watanabe Manabu