This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
648
National Multiprofile Transport Hospital Tsar Boris III
Sofia, Bulgaria
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)
Time frame: Week 24
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.
Time frame: Week 24
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.
Time frame: Up to Week 52
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.
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Time frame: Week 24
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.
Time frame: Up to Week 52