DCE-MRI Study (Dynamic Contrast-Enhanced Magnetic Resonance Imaging)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Etanercept |
Phase 1 |
Amgen has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | DCE-MRI of the Wrist to Measure Short-Term Responses in Rheumatoid Arthritis Subjects Treated With Etanercept |
| Enrollment: | 14 |
| Study Start Date: | September 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Treatment |
Drug: Etanercept
50mg SC dose
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 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
- Subjects 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 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 screws
- allergic to contrast agent
- tattoos [in area of examination if contains metallic pigment])
- or will likely require sedation for the procedure
Contacts and Locations| United States, California | |
| Research Site | |
| Los Angeles, California, United States | |
| United States, Washington | |
| Research Site | |
| Seattle, Washington, United States | |
| United Kingdom | |
| Research Site | |
| London, United Kingdom | |
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00361634 History of Changes |
| Other Study ID Numbers: | 20060118 |
| Study First Received: | August 4, 2006 |
| Last Updated: | July 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Etanercept Enbrel DCE-MRI RA |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013