Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02175589
Study type Interventional
Source Rambam Health Care Campus
Contact
Status Enrolling by invitation
Phase Phase 2
Start date June 2014
Completion date January 2015

See also
  Status Clinical Trial Phase
Recruiting NCT00658060 - Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients N/A
Withdrawn NCT05448391 - A Study to Evaluate RIST4721 in Familial Mediterranean Fever (FMF) Phase 2
Recruiting NCT05190991 - Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever Phase 2
Completed NCT00094900 - Interleukin-1 Trap to Treat Autoinflammatory Diseases Phase 2
Not yet recruiting NCT06033339 - Assessment of microRNAs Role in Familial Mediterranean Fever FMF Pathophysiology N/A
Completed NCT01705756 - Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever Phase 3
Recruiting NCT06338891 - Can Gluten/Wheat or Other Foods be Responsible for FMF Attacks
Recruiting NCT05596643 - Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever
Completed NCT05177120 - Central Sensitization in Familial Mediterranean Fever (FMF)
Active, not recruiting NCT06257342 - Physical Abilities of Teenagers With Familial Mediterranean Fever
Recruiting NCT04478409 - Characterization of a Functional Test for Mediterranean Family Fever Screening - 2
Recruiting NCT06034795 - Evaluation of Bone Metabolism in Children and Adolescents With Familial Mediterranean Fever
Completed NCT04729218 - The Movement Imagery Ability in Patients With Familial Mediterranean Fever
Terminated NCT01059279 - Heat Intolerance in the Group of FMF Patients
Enrolling by invitation NCT04724993 - Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever N/A
Completed NCT03747315 - A Diagnostic Test for Familial Mediterranean Fever
Completed NCT01075906 - Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients Phase 1
Withdrawn NCT00323440 - Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission N/A
Completed NCT00582907 - Rilonacept for Treatment of Familial Mediterranean Fever (FMF) Phase 2
Not yet recruiting NCT05488561 - Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings N/A