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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P47 SC (tocilizumab) | Experimental | CT-P47 (tocilizumab) by subcutaneous (SC) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P47 AI (tocilizumab) | Biological | CT-P47 (162 mg/0.9 mL) by subcutaneous (SC) injection via autoinjector (AI) at Week 0 and Week 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The usability of AI as assessed by patients rating using POST-Self-Injection Assessment Questionnaire (SIAQ) at 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. | Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YeonJu Kim | Contact | +82-32-850-5000 | yeonju.kim2@celltrion.com |
| Name | Affiliation | Role |
|---|---|---|
| Klimiuk Piotr, MD, PhD | INTER CLINIC Piotr Adrian Klimiuk | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39803727 | Derived | Burmester G, Klimiuk PA, Trefler J, Jaworski J, Kim S, Bae Y, Jeon D, Lee H, Jang J, Hwang C, Lee H, Smolen JS. Usability, efficacy, and safety of candidate tocilizumab biosimilar CT-P47 self-administration via auto-injector and pre-filled syringe in patients with rheumatoid arthritis: a single-arm, open-label, phase 3 study. Expert Rev Clin Immunol. 2025 Apr;21(4):521-529. doi: 10.1080/1744666X.2025.2451215. Epub 2025 Jan 15. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| CT-P47 PFS (tocilizumab) | Biological | CT-P47 (162 mg/0.9 mL) by SC injection via pre-filled syringe from Week 4 every other week or weekly (based on the clinical response by investigator's discretion) up to Week 10 |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |