Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation
Launched by RAMBAM HEALTH CARE CAMPUS · Jun 25, 2014
Trial Information
Current as of May 06, 2025
Unknown status
Keywords
ClinConnect Summary
The diagnosis of FMF is mainly clinical and genetic tests are only used to confirm the diagnosis . Even though the disease is autosomal recessive, not all FMF patients have two recognizable MEFV mutations. The phenotype of FMF patients varies according to the genotype, as shown by a number of studies showing that patients with one MEFV mutation have milder disease or even no symptoms. Some of the previously mentioned studies have shown that ceasing colchicine prophylaxis in these patients caused no recurrence. So far, no prospective controlled study has tested the effect of colchicine cessa...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients diagnosed with FMF based on clinical criteria
- • FMF patients diagnosed of having at least one common MEFV mutation will be assigned to the study group. FMF patients who staid on colchicine treatment will be assigned to the control group, regardless of their genotype.
- • Patients who were on a continuous colchicine prophylactic treatment for six months prior to entering the study.
- • FMF patients who were free of acute FMF symptoms for six months prior to entering th study
- • Patients were included in the study only if they had normal serum level of SAA (up to 10 mg / l).
- Exclusion Criteria:
- • Patients that in the six months prior to entering the study continued to have classic FMF episodes despite being on a continuous prophylactic colchicine
- • Patients that had high level of SAA (above 10 mg/l) despite being on prophylactic colchicine treatment
About Rambam Health Care Campus
Rambam Health Care Campus is a leading medical institution located in Haifa, Israel, renowned for its comprehensive patient care, advanced research initiatives, and commitment to medical education. As a prominent clinical trial sponsor, Rambam is dedicated to advancing healthcare through innovative research and development, facilitating a wide range of clinical studies across various therapeutic areas. The campus boasts state-of-the-art facilities, a multidisciplinary team of expert researchers and clinicians, and a robust infrastructure that supports rigorous scientific inquiry and ethical standards in clinical trials. By fostering collaboration and leveraging cutting-edge technology, Rambam Health Care Campus aims to enhance treatment options and improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Petach Tikva, , Israel
Haifa, , Israel
Patients applied
Trial Officials
Yonatan Butbul, MD
Study Chair
Rambam Health Care Campus
Riva Brik, MD
Principal Investigator
Rambam Health Care Campus
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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