The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
- Registration Number
- NCT01213017
- Lead Sponsor
- Oklahoma Medical Research Foundation
- 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 rheumatoid arthritis.
- 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 bone edema MRI scores at week 6.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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
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Exclusion Criteria
- concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Certolizumab pegol certolizumab pegol -
- Primary Outcome Measures
Name Time Method the change from baseline in synovitis and bone edema RAMRIS score. 6 weeks
- Secondary Outcome Measures
Name Time Method the change from baseline in RAMRIS erosion score 16 and 52 weeks
Trial Locations
- Locations (2)
Arthritis and Rheumatic Disease Specialties
🇺🇸Aventura, Florida, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States