Back to resultsA Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CT-P47
EU-approved RoActemra
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CT-P47
EU-approved RoActemra
Arm Description
CT-P47(Tocilizumab)
EU-approved RoActemra(Tocilizumab)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05489224
Brief Title
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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 demonstrate similar efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
448 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT-P47
Arm Type
Experimental
Arm Description
CT-P47(Tocilizumab)
Arm Title
EU-approved RoActemra
Arm Type
Active Comparator
Arm Description
EU-approved RoActemra(Tocilizumab)
Intervention Type
Biological
Intervention Name(s)
CT-P47
Intervention Description
CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)
Intervention Type
Biological
Intervention Name(s)
EU-approved RoActemra
Intervention Description
EU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W
Primary Outcome Measure Information:
Title
Mean Change from Baseline in Disease Activity Score 28 (DAS28) using Erythrocyte Sedimentation Rate (ESR)
Description
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
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of Patients Achieving an American College of Rheumatology (ACR)20 response
Description
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
Time Frame
Week 52
Title
Proportion of Patients Achieving an ACR50 response
Description
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
Time Frame
Week 52
Title
Proportion of Patients Achieving an ACR70 response
Description
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
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujin Hyoung
Phone
032-850-5000
Email
yujin.hyoung@celltrion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klimiuk Piotr
Organizational Affiliation
INTER CLINIC Piotr Adrian Klimiuk
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
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