Status:
COMPLETED
A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Celltrion
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2020
Estimated Enrollment :
648 Patients enrolled
Trial Details
Trial ID
NCT03789292
Start Date
November 26 2018
End Date
April 24 2020
Last Update
November 17 2021
Active Locations (1)
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1
National Multiprofile Transport Hospital Tsar Boris III
Sofia, Bulgaria