A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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 demonstrate similar efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Official Title
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A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: CT-P47
* Biological: EU-approved RoActemra


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P47<br>CT-P47(Tocilizumab) | Biological: CT-P47<br>* CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)<br>|
| Active Comparator: EU-approved RoActemra<br>EU-approved RoActemra(Tocilizumab) | Biological: CT-P47<br>* CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)<br>Biological: EU-approved RoActemra<br>* EU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in Disease Activity Score 28 (DAS28) using Erythrocyte Sedimentation Rate (ESR) | DAS28 (ESR) is assessed using the following variables: tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR), and patients assessment of global disease activity | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Achieving an American College of Rheumatology (ACR)20 response | ACR20 responders are patients with at least 20% improvement from baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's assessment of global disease activity, physician's assessment of global disease activity, health assessment questionnaire (HAQ) estimate of physical activity, and serum CRP centration or ESR | Week 52 | 
| Proportion of Patients Achieving an ACR50 response | ACR50 responders are patients with at least 50% improvement from baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's assessment of global disease activity, physician's assessment of global disease activity, health assessment questionnaire (HAQ) estimate of physical activity, and serum CRP centration or ESR | Week 52 | 
| Proportion of Patients Achieving an ACR70 response | ACR70 responders are patients with at least 70% improvement from baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's assessment of global disease activity, physician's assessment of global disease activity, health assessment questionnaire (HAQ) estimate of physical activity, and serum CRP centration or ESR | Week 52 |