The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/9/2017 |
| Start Date: | September 2010 |
| End Date: | April 2012 |
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.
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.
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.
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
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