Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT00658060
Eligibility Criteria:
Inclusion Criteria:
1. Fulfilling the Tel Hashomer criteria for the diagnosis of FMF \[5\].
2. Suffering from episodes of exertional leg pain and or exertional ankle edema
3. 18-45 years old
4. On a stable (≥ 2 weeks) dose of oral colchicine therapy
5. Non-smokers
Exclusion Criteria:
1. with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia)
2. Suffering from muscular or neurological diseases not related to FMF
3. With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels.
4. Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00658060
Study Brief:
Protocol Section:
NCT00658060