Back to resultsA Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Bulgaria
Study Type
Interventional
Intervention
CT-P17 SC
Humira SC
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 rheumatoid arthritis according to the 2010 American College of Rheumatology(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; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
- 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
- National Multiprofile Transport Hospital Tsar Boris III
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CT-P17 Subcutaneous(SC) (adalimumab)
Humira SC (adalimumab)
Arm Description
CT-P17 SC (adalimumab)
Humira SC (adalimumab)
Outcomes
Primary Outcome Measures
American College of Rheumatology(ACR)20 Response Rate at Week 24.
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
Secondary Outcome Measures
ACR50 and ACR70 Response Rate at Week 24
ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
ACR20, ACR50, and ACR70 Response Rate up to Week 52
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)
The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96
Where:
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.
Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)
The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96
Where:
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03789292
Brief Title
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Official Title
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
October 8, 2019 (Actual)
Study Completion Date
April 24, 2020 (Actual)
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 III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis
Detailed Description
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira 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
648 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P17 Subcutaneous(SC) (adalimumab)
Arm Type
Experimental
Arm Description
CT-P17 SC (adalimumab)
Arm Title
Humira SC (adalimumab)
Arm Type
Active Comparator
Arm Description
Humira SC (adalimumab)
Intervention Type
Biological
Intervention Name(s)
CT-P17 SC
Intervention Description
Subcutaneous injection of Adalimumab 40mg every two weeks
Intervention Type
Biological
Intervention Name(s)
Humira SC
Intervention Description
Subcutaneous injection of Adalimumab 40mg every two weeks
Primary Outcome Measure Information:
Title
American College of Rheumatology(ACR)20 Response Rate at Week 24.
Description
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
ACR50 and ACR70 Response Rate at Week 24
Description
ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
Time Frame
Week 24
Title
ACR20, ACR50, and ACR70 Response Rate up to Week 52
Description
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.
Time Frame
Up to Week 52
Title
Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)
Description
The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96
Where:
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.
Time Frame
Week 24
Title
Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)
Description
The Disease activity score (DAS28) (c-reactive protein [CRP]) score was derived using the following formulae:
DAS28 (CRP) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.36*ln(CRP+1) + 0.96
Where:
TJC28 = 28 joint count for tenderness (0-28) SJC28 = 28 joint count for swelling (0-28) Ln (CRP) = natural logarithm of CRP (mg/L : 0.2-236.3 as observed in the study) GH = General Health component of the DAS (patient's global assessment of disease activity) (mm: 0-100).
DAS28 (CRP) values range from 1.03 to 8.77 while higher values mean a higher disease activity.
Time Frame
Up to 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 rheumatoid arthritis according to the 2010 American College of Rheumatology(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; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MinJi Ma
Organizational Affiliation
Celltrion, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
National Multiprofile Transport Hospital Tsar Boris III
City
Sofia
Country
Bulgaria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34142111
Citation
Furst DE, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Kim SH, Bae YJ, Yang GE, Yoo JK, Kay J, Keystone E. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis. Rheumatology (Oxford). 2022 Apr 11;61(4):1385-1395. doi: 10.1093/rheumatology/keab460.
Results Reference
derived
PubMed Identifier
33546755
Citation
Kay J, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Bae YJ, Yang GE, Yoo JK, Furst DE, Keystone E. Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021 Feb 5;23(1):51. doi: 10.1186/s13075-020-02394-7.
Results Reference
derived
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A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
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