DCE-MRI Study (Dynamic Contrast-Enhanced Magnetic Resonance Imaging)
Information source: Amgen
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Etanercept (Drug)
Phase: Phase 1
Sponsored by: Amgen
Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
Amgen Call Center, Phone: 866-572-6436
The purpose of this study is to assess whether DCE-MRI can detect changes of active disease
in RA subjects after 4, 8 and 12 weeks of etanercept.
Official title: DCE-MRI of the Wrist to Measure Short-Term Responses in Rheumatoid Arthritis Subjects Treated With Etanercept
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacodynamics Study
Primary outcome: To assess the sensitivity of DCE-MRI to detect changes in the wrist of RA subjects with active disease after 4, 8 and 12 weeks of etanercept treatment.
To assess whether DCE-MRI can detect an etanercept effect after 4, 8, and 12 weeks of etanercept treatment when compared to 4 week etanercept-free period.
To assess the test-retest variability of DCE-MRI endpoints by comparing baseline data from Days -30 and -28.
To assess the sensitivity of non-dynamic MRI endpoints.
The current literature shows the promise of MRI for assessing response to therapy in RA but
the heterogeneity of the methodology and the semi-quantitative nature of the image analysis
limits its applicability. To evaluate the ability of DCE-MRI to serve as a biomarker for
treatment-induced changes in RA associated synovial inflammation, the reproducibility of the
measurement and an effect size are required. Additional endpoints such as synovial volume,
bone erosion progression and bone marrow edema-like changes may also prove useful for
short-term assessment of a therapeutic intervention, but have not been explored in the
context of a pharmacodynamic biomarker. It is therefore critical to conduct a carefully
designed longitudinal study, focused on identifying the key parameters related to the
instrumentation and data analysis, to fully evaluate the potential utility of MRI in an
early clinical development setting. Importantly, this study will also demonstrate the
feasibility of using DCE-MRI at multiple centers to acquire useful information that will
drive program decisions.
Expanded Access: Amgen provides expanded access for this clinical trial. Contact the Amgen
Call Center (866-572-6436) for more information.
Minimum age: 18 Years.
Maximum age: N/A.
- Fulfillment of the 1987 American College of Rheumatology (ACR) criteria for RA
(Appendix F) with a disease duration > 6 months
- Presence of active disease (defined as both tender and swollen joints) in at least
- 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
- Subjects must be receiving MTX at a stable dose > 15 mg/week at least 12 weeks prior
- a lower dose is acceptable if otherwise not tolerated (toxicity documentation
required) Exclusion Criteria:
- Subjects who are currently receiving DMARD therapy (other than MTX,
hydroxychloroquine or sulfasalazine) including 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
- allergic to contrast agent
- tattoos [in area of examination if contains metallic pigment])
- or will likely require sedation for the procedure
Locations and Contacts
Amgen Call Center, Phone: 866-572-6436
Research Site, London, United Kingdom; Recruiting
Research Site, Los Angeles, California, United States; Recruiting
Research Site, Seattle, Washington, United States; Recruiting
AmgenTrials clinical trials website
Starting date: September 2006
Ending date: December 2008
Last updated: July 16, 2009