A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis
Phase 3
Not yet recruiting
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: CT-P47 AI (tocilizumab)Biological: CT-P47 PFS (tocilizumab)
- Registration Number
- NCT05725434
- Lead Sponsor
- Celltrion
- Brief 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.
- Detailed Description
CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CT-P47 SC (tocilizumab) CT-P47 AI (tocilizumab) CT-P47 (tocilizumab) by subcutaneous (SC) injection CT-P47 SC (tocilizumab) CT-P47 PFS (tocilizumab) CT-P47 (tocilizumab) by subcutaneous (SC) injection
- Primary Outcome Measures
Name Time Method The usability of AI as assessed by patients rating using POST-Self-Injection Assessment Questionnaire (SIAQ) at Week 2. Week 2 The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence, pain and skin reactions, ease of use and satisfaction with self-injection.
- Secondary Outcome Measures
Name Time Method