Status:
COMPLETED
The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
Lead Sponsor:
Oklahoma Medical Research Foundation
Collaborating Sponsors:
UCB Pharma
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active moderate to severe r...
Detailed Description
The primary objective of this study is to evaluate the efficacy of CSP used in combination with MTX in patients with active moderate to severe RA by evaluating change from baseline in synovitis and bo...
Eligibility Criteria
Inclusion
- moderate to severe RA (DAS \> 4.4)
- at least two swollen and tender joints in one of the hand/ wrist
- patients must have failed at least one non-biologic or biologic DMARDs
- currently receiving MTX therapy
Exclusion
- concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01213017
Start Date
September 1 2010
End Date
April 1 2012
Last Update
December 7 2017
Active Locations (2)
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1
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
2
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104