Rheumatoid Arthritis Clinical Trial
Official title:
Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet
Verified date | May 2022 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patient must meet 1987 ACR (American College of Rheumatology) criteria 2. Age > 18 years of age 3. Baseline DAS28/ESR>3.2 (ESR-erythrocyte sedimentation rate) 4. Stable DMARDs or biologic therapy for at least 12 weeks, or stable off RA therapy 12 weeks. 5. Willingness to participate in a weight loss program 6. BMI > 30 7. Prednisone = 10 mg 8. Patient has provided informed consent Exclusion Criteria: 1. Major surgery (including joint surgery) within 8 weeks prior to baseline or planned major surgery within 3 months after baseline 2. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease 3. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (as this may falsely elevate biomarkers) 4. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of baseline or oral antibiotics within 2 weeks prior to baseline 5. Pregnant women or nursing (breast feeding) mothers 6. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation 7. History of an eating disorder 8. History of bariatric surgery 9. EKG results deeming patient to unsafe for study intervention 10. Allergy to study intervention |
Country | Name | City | State |
---|---|---|---|
United States | UCLA David Geffen School of Medicine, Division of Rheumatology | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Veena Ranganath, MD, MS |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in PDUS | Change in Synovitis measure using Ultrasound | change from baseline to 6 and 12 months | |
Primary | change in DAS28 | Change in DAS28 represents conventional measure of reduced disease activity | change from baseline to 6 and 12 months | |
Secondary | MBDA | Biomarker | Baseline, 6 weeks and 12 weeks |
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