A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT05489224
- Lead Sponsor
- Celltrion
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 471
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EU-approved RoActemra EU-approved RoActemra EU-approved RoActemra(Tocilizumab) EU-approved RoActemra CT-P47 EU-approved RoActemra(Tocilizumab) CT-P47 CT-P47 CT-P47(Tocilizumab)
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24 Week 24 The DAS28(ESR) score was derived using the following formulae:
DAS28 (ESR)=(0.56 ×√TJC28)+(0.28 × √SJC28)+(0.70 × ln\[ESR\])+(0.014 ×GH)
Where:
* TJC28 = number of tender joints (0-28): tender joint count (TJC)
* SJC28 = number of swollen joints (0-28): swollen joint count (SJC)
* ESR = ESR measurement (mm/hour)
* GH = patient's global disease activity measured on VAS (mm: 0-100)
DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in DAS28 (ESR) at Week 32 Week 32 The DAS28(ESR) score was derived using the following formulae:
DAS28 (ESR)=(0.56 ×√TJC28)+(0.28 × √SJC28)+(0.70 × ln\[ESR\])+(0.014 ×GH)
Where:
* TJC28 = number of tender joints (0-28): tender joint count (TJC)
* SJC28 = number of swollen joints (0-28): swollen joint count (SJC)
* ESR = ESR measurement (mm/hour)
* GH = patient's global disease activity measured on VAS (mm: 0-100)
DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity.ACR20, ACR50, and ACR70 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). 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 at Week 32 Week 32 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)
INTER CLINIC Piotr Adrian Klimiuk
🇵🇱Bialystok, Poland