An observational study in Familial Mediterranean Fever and Central Sensitisation, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by Marmara University · Observational
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Among 20 studies in Familial Mediterranean Fever with a site in Turkey — 7 open to participants now, 8 under way, none of them phase 3. Familial Mediterranean Fever · Turkey.
Among the 20 studies in Familial Mediterranean Fever with a site in Turkey, this one is the 3rd largest by enrollment of the 10 observational ones that give a count, is one of 3 that started in 2021, is one of 10 observational ones, and was the 9th registered.
61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.
Browse Familial Mediterranean Fever studies →7 of the 20 studies in Familial Mediterranean Fever with a site in Turkey are open now. Recruiting first, the newest first:
R-Pharm International, LLC · Sites in Turkey, Armenia, Russian Federation
Ages 18–80
Istanbul University · Sites in Turkey
Ages 8–18
Istanbul University - Cerrahpasa · Sites in Turkey
Ages 12–18
Istanbul University - Cerrahpasa · Sites in Turkey
Ages 12–18 · Healthy volunteers
Aysima Barlak · Sites in Turkey
Ages 18+
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 12 Familial Mediterranean Fever studies recruiting now, 4 (33%) set no upper age limit and 5 (42%) stop at 75 or younger; 10 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 4 · Phase 3 1 · Phase 4 1
First in 2001; this study’s year is marked. 3 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 is above the median of 89 across 30 observational studies indexed under Familial Mediterranean Fever.
Median enrollment 60 across the 10 interventional studies, 80 across the 10 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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5 of 20 have an industry lead sponsor. The 10 most frequent:
Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Marmara University has 2 studies filed under Familial Mediterranean Fever — fewer than ten, so there is no comparison to draw.
1 of the studies in Familial Mediterranean Fever with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06830213Aysima BarlakInvestigation of the Validity, Reliability and Responsiveness of the BETY-BQ in FMF | 2027-03-30 |
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Among the 20 studies in Familial Mediterranean Fever with a site in Turkey, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Familial Mediterranean Fever (FMF) is an autosomal recessive inherited disease with a course of autoinflammation, which is characterized by the episodes of fever and serositis. Central sensitization (CS) is defined as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with many rheumatological diseases has been demonstrated in several studies. However, there are no data on the frequency of CS in FMF patients.
Familial Mediterranean fever (FMF) is a self-limiting autoinflammatory disease with well-defined genetic and clinical features. Recurrent episodes of fever and serositis accompanied by increased acute phase reactants and good response to colchicine are the core components of the disease. The frequency of this disease, which is common in Eastern Mediterranean countries, is variable according to regions, but it is reported as 1/1000. In the pathogenesis of the disease, the mutation of the MEFV (Mediterranean Fever) gene, which is located on the 16th chromosome and encodes the pyrin protein, is known as the basic mechanism.In rheumatic diseases, inflammatory mediators cause CS by first creating changes in the regulation of pain in peripheral neurons and then in spinal and supraspinal pathways. Stimulation of peripheral nerves by mediators released during inflammation results in neurogenic inflammation, which is among the peripheral sensitization (PS) mechanisms. PS is defined as the increased sensitivity of nociceptive neurons to normal or below-threshold stimuli and constitutes the first step in the development of CS.Similar to other autoimmune diseases, it is possible that the neuroinflammatory process triggers peripheral and central sensitization mechanisms in FMF patients and affects pain pathways.
Patients with FMF
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with diagnosed FMF
Diagnostic Test: Central Sensitization Inventory · Other: Short form-36 · Other: Pittsburgh Sleep Quality Index · Other: Health assessment questionnaire · Other: Hospital anxiety and depression scale · Diagnostic Test: Fibromyalgia rapid screening tool · Other: Familial Mediterranean Fever Quality of life scale
Standardized questionnaire to determine the level of central sensitization
Also known as: CSI
Standardized questionnaire to investigate the quality of life in patients
Also known as: SF-36
Standardized questionnaire to investigate the sleep quality and disturbance
Also known as: PSQI
Standardized questionnaire used to detect the presence of disability
Also known as: HAQ
Standardized questionnaire to investigate the depression and anxiety
Also known as: HADS
Standardized questionnaire to determine the presence of fibromyalgia
Also known as: FIRST
Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients
Also known as: FMFQoL
Central Sensitization Inventory (CSI)
25 somatic and psychosocial symptoms, which are frequently found in patients with central sensitization in part A, are questioned. In part B, the presence of diseases whose relationship with central sensitization is well defined is questioned in the patient without participating in scoring. Central sensitization is assumed in patients who score 40 or more over 100 points.
Time frame: 6 months
Short form-36 (SF-36)
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.The scale consists of 36 questions questioning 8 sub-parameters regarding the health status of the person.These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception. High scores are associated with improved quality of life.
Time frame: 6 months
Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)
FMF-QoL was developed to evaluate the quality of life in FMF patients. This scale consists of 20 questions in the form of a Likert scale and the total scoring is between 0-80. High scores indicate a decrease in quality of life.
Time frame: 6 months
Health Assessment Questionnaire (HAQ)
n the scale, difficulty in performing 20 specific tasks from 8 categories is questioned and the scoring is between 0-60. High scores are associated with increased disability.
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS)
This scale consists of 14 questions in total, and anxiety symptoms are questioned in half of the questions and depression-related complaints in the other half. A subscore of 8 or higher for depression or anxiety is considered a clinical case.
Time frame: 6 months
Pittsburgh Sleep Quality Index (PSQI)
The questionnaire includes 21 questions covering 7 components that investigate the symptoms of sleep disturbances. Scores range from 0 to 21 and a score of \>5 is considered as a sleep disorder.
Time frame: 6 months
Fibromyalgia Rapid Screening Tool (FIRST).
This scale consists of 6 questions investigating the most relevant clinical features of fibromyalgia. The questions are answered as yes/no and 5 or more out of 6 points in total are in favor of fibromyalgia.
Time frame: 6 months
Ran from Jun 2021 to primary completion in Apr 2022, 10 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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