A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: CT-P17 SCBiological: Humira SC
- Registration Number
- NCT03789292
- Lead Sponsor
- Celltrion
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 648
- 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 .
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Humira SC (adalimumab) CT-P17 SC Humira SC (adalimumab) CT-P17 Subcutaneous(SC) (adalimumab) CT-P17 SC CT-P17 SC (adalimumab) Humira SC (adalimumab) Humira SC Humira SC (adalimumab)
- Primary Outcome Measures
Name Time Method American College of Rheumatology(ACR)20 Response Rate at Week 24. 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
Name Time Method Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP) Up to Week 52 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.ACR50 and ACR70 Response Rate at Week 24 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 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.
Trial Locations
- Locations (1)
National Multiprofile Transport Hospital Tsar Boris III
🇧🇬Sofia, Bulgaria