Rheumatoid Arthritis Clinical Trial
— PICSOfficial title:
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
Verified date | December 2017 |
Source | Oklahoma Medical Research Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2012 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Arthritis and Rheumatic Disease Specialties | Aventura | Florida |
United States | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Oklahoma Medical Research Foundation | UCB Pharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the change from baseline in synovitis and bone edema RAMRIS score. | 6 weeks | ||
Secondary | the change from baseline in RAMRIS erosion score | 16 and 52 weeks |
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