The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients
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.
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.
400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks
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 Exclusion Criteria: concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment