Status:
COMPLETED
Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis
Lead Sponsor:
Amgen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess whether DCE-MRI can detect changes of active disease in rheumatoid arthritis (RA) patients after 4, 8 and 12 weeks of etanercept.
Detailed Description
The current literature shows the promise of magnetic resonance imaging (MRI) for assessing response to therapy in RA but the heterogeneity of the methodology and the semi-quantitative nature of the im...
Eligibility Criteria
Inclusion
- Fulfillment of the 1987 American College of Rheumatology (ACR) criteria for RA with a disease duration \> 6 months
- Presence of active disease (defined as both tender and swollen joints) in at least one wrist
- Sub-optimal response to methotrexate (MTX) defined by the presence of the following criteria (based on 68/66 joint count): 8 or more swollen joints AND 8 or more tender joints (with involvement of the wrist, fingers and at least one region outside the hands) at screening
- Must be receiving MTX at a stable dose \> 15 mg/week at least 12 weeks prior to baseline
- a lower dose is acceptable if otherwise not tolerated (toxicity documentation required).
Exclusion
- Patients who are currently receiving disease modifying anti-rheumatic drug (DMARD) therapy (other than MTX, hydroxychloroquine or sulfasalazine) including tumor necrosis factor (TNF) antagonists (etanercept, infliximab, and adalimumab), abatacept, rituximab, leflunomide, cyclosporine, and gold (oral and intramuscular injection) within 8 weeks or 5.5 half-lives, whichever is longer, of screening
- Co-existing condition requiring medications that alter vascular flow (e.g., nitrates, calcium channel blockers, ergot containing drugs) \[Potential effects of antihypertensive and migraine medications will be discussed with the Sponsor\]
- Comorbid autoimmune disorders including systemic lupus erythematosus
- Unable to undergo an MRI examination (e.g., presence of a pacemaker, defibrillator, or other implanted device such as anterior interbody cages, aneurysm clip or pedicle screws
- allergic to contrast agent
- tattoos \[in area of examination if contains metallic pigment\])
- or will likely require sedation for the procedure
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00361634
Start Date
September 1 2006
End Date
March 1 2010
Last Update
September 17 2013
Active Locations (3)
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1
Research Site
Los Angeles, California, United States
2
Research Site
Seattle, Washington, United States
3
Research Site
London, United Kingdom