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NCT05725434
A Phase 3 Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Moderate to Severe Active Rheumatoid Arthritis
Conditions: Rheumatoid Arthritis
Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE3
Enrollment: 30
Sponsor: Celltrion
Summary
This is a phase 3 study to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe active rheumatoid arthritis.
Eligibility Criteria
Inclusion Criteria:Patient is male or female aged 18 to 70 years old, both inclusive.Patient must be able and willing to self-administer SC injections.Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria (Aletaha et al., 2010) for at least 24 weeks prior to the first administration of the study drug (Day 1).Exclusion Criteria:Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.Patient who has previously received more than 1 biologic agents approved for the treatment of RA.Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Source: ClinicalTrials.gov (NCT05725434). StuddyBuddy aggregates publicly available trial information.