A Phase 2 interventional study of Colchicine Cessation in Familial Mediterranean Fever, sponsored by Rambam Health Care Campus. Status unknown at 2 sites in Israel. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by Rambam Health Care Campus · Phase 2, Interventional, and Treatment
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The purpose of this study is to evaluate the effect of discontinuation of colchicine treatment in a specific group of asymptomatic FMF patients with a single mutation in MEFV gene, both from a clinical and laboratory aspects.
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 cessation in this group of FMF patients. The investigators presume that asymptomatic FMF patients with a single mutation can stop regular colchicine treatment while remaining under close follow-up.
The purpose of the work:
To examine the effect of colchicine cessation in a defined group of asymptomatic FMF patients with a single mutation in MEFV gene.
Methods and study population:
The work will be a controlled prospective comparative study including FMF patients aged 2-18 years. Patients included will be those who were asymptomatic for six months prior to entering the study and were regularly treated with colchicine, and with a normal serum level of Serum Amyloid A (SAA). The study group will include patients with a single MEFV mutation that will stop colchicine therapy, and the control group will include FMF who will continue regular colchicine treatment. Follow-up in both groups will include clinical and laboratory (serum SAA levels) evaluation.
The study end points and renewal of the colchicine:
Any patient that develops acute symptoms of FMF will be immediately invited to the rheumatology clinic for medical examination. In addition, patients will be invited to the clinic after 3 and 6 months from the beginning of the study. At any clinic visit (scheduled or not) the patients will be assessed clinically and laboratory (serum SAA levels). The study will be stopped and colchicine will be renewed if at any of the above mentioned clinic visit the patient will be diagnosed as having a classic FMF attack or the SAA level will be above 10 mg / l.
The importance of the study:
If the investigators conclude that colchicine prophylaxis can be safely discontinued in this group of FMF patients this will save them a treatment currently defined as a treatment for life.
61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 27 interventional studies indexed under Familial Mediterranean Fever.
Browse Familial Mediterranean Fever studies →Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Colchicine Cessation in FMF patients with one MEFV mutation
Other: Colchicine Cessation
The control group includes FMF patients that will be kept on a daily colchicine treatment
Colchicine Cessation
Acute clinical episode of FMF
Acute clinical episode of FMF diagnosed by one of the investigators at any clinic visit assigned at 3 or 6 months after the cessation of colchicine treatment or at an unassigned visit if the patient attained the clinic due to an acute symptoms of FMF
Time frame: 6 months
High level of Serum Amyloid A (SAA) in serum
High level of SAA (above 10 mg/l) at any clinic visit assigned at 3 or 6 months after the cessation of colchicine treatment or at an unassigned visit if the patient attained the clinic due to an acute symptoms of FMF
Time frame: 6 months
The record gives a start of Jun 2014, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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