Phase 3
Completed N=471
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT05489224 ↗Enrolled (actual)
471
Serious AEs
3.1%
Results posted
Oct 2024
Primary outcomePrimary: Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24 — -3.77; -3.67 units on a scale
◆ Published Evidence
Emerging
4citations · ~4 / year
Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis.
Summary
This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.
Linked Publications
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Efficacy and Safety of Biosimilar CT-P47 Versus Reference Tocilizumab: 1-Year Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study in Patients with Rheumatoid Arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24 |
-3.77; -3.67 | — |
| SECONDARY Mean Change From Baseline in DAS28 (ESR) at Week 32 |
-3.921; -3.994; -4.218 | — |
| SECONDARY ACR20, ACR50, and ACR70 Response Rate at Week 24 |
199; 189; 142; 146; 100; 99 | — |
| SECONDARY ACR20, ACR50, and ACR70 Response Rate at Week 32 |
199; 96; 98; 148; 79; 77 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is male or female aged 18 to 75 years old, both inclusive.
- Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug.
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.
Data sourced from ClinicalTrials.gov (NCT05489224) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.