A Phase 4 interventional study of colchicine in Familial Mediterranean Fever, sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi. Completed at 1 site in Turkey. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2015-11-11.
Sponsored by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi · Phase 4, Interventional, and Treatment
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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 interventional ones that give a count, is the only one that started in 2011, is the only one in phase 4, and was the 4th 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: 5 Years to 16 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. 1 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 79 is above the median of 40 across 27 interventional 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:
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi is the lead sponsor of 66 studies on the registry; 8 are open to participants now.
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi has 1 study 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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It was aimed to examine the efficacy and safety of once daily dosage schema of colchicine in pediatric patients with FMF compared to twice daily dosage schema.
In this 24-week, multicentric, randomized, controlled, noninferiority trial, pediatric patients newly diagnosed with FMF, carrying homozygote or compound heterozygote mutation and did not receive any treatment, were included. Patients were randomly assigned using block randomization method to receive treatment with once or twice daily doses. Clinical and laboratory characteristics and medication side effects were recorded and compared between groups. The study complied with Good Clinical Practice and the Consolidated Standards for Reporting of Trials (CONSORT) statement.
Study design This study was conducted by members of the FMF Arthritis Vasculitis and Orphan disease Research in Pediatric Rheumatology (FAVOR, www.favor.org.tr) at 10 centers in Turkey. This is a multicentric randomized controlled, noninferiority trial of two parallel groups being followed up in pediatric rheumatology outpatient clinics. The randomization was done at baseline visit and patients were assessed in two more visits, three months apart. The study complied with Good Clinical Practice (GCP) and the Consolidated Standards for Reporting of Trials (CONSORT) statement.
Participants Inclusion criteria Pediatric patients who were newly diagnosed with Familial Mediterranean Fever according to Yalcinkaya or Tel-Hashomer criteria and who were confirmed with the genetic analysis as having compound heterozygote or homozygote mutation were enrolled. Eligible patients between ages of 5-16 and weighted 15-30 kg who and had not received any treatment were included. All patients included were asked the physicians to be proved and recorded as having at least one FMF attack before enrollment for the study.
Exclusion criteria Patients with a major congenital malformation, with a risk of pregnancy, and with other chronic diseases such as organ transplantation, hepatic disorder chronic kidney disease and AA amyloidosis, thyroid disease or rheumatologic disorders other than FMF, were excluded.
Baseline assessment and Outcome Measures At the baseline visit, medical history and complaints about the disease were questioned and physical examination and laboratory tests were performed. In following visits, any attack or findings due to colchicine since the last visit were investigated in addition to baseline visit.
Interventions The once daily dosage group was prescribed as once daily at 08:00 a.m. and the twice daily dosage group received the treatment twice daily at 08:00 a.m. and 08:00 p.m. Disease severity was assessed via Mor scoring system, modified for pediatric patients in all visits. A physician from each center was chosen to be responsible for data collection. After each visit the data was registered to a web-based registry system in "www.favor.org.tr" web site. To ensure accurate, complete, and reliable data, the following procedures were followed: data collection, encoding, and storage had been provided for the centers; a training session had been held to provide instruction on the protocol; periodic meetings had been held with study coordinators the principal investigator stayed in contact with the study coordinators by mail, telephone, and/or fax; and finally a data manager reviewed and evaluated the data.
Colchicine dosage The required colchicine dosage was calculated as total 1 mg daily according to internationally accepted advisory. All patients were prescribed 0.5 mg Colchicine tablets. Patients in once daily dosage group were given 2 tablets of Colchicine at 08.00 a.m. Twice daily dosage group received 1 tablet of 0,5 mg Colchicine at 08:00 a.m. and 1 tablet of 0,5 mg Colchicine at 08:00 p.m.
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Exclusion criteria:
The once daily dosage group was prescribed as once daily at 08:00 a.m. (Total 1mg)
Drug: colchicine
Twice daily dosage group received the treatment twice daily at 08:00 a.m. and 08:00 p.m. (Total 1mg)
Drug: colchicine
to compare once daily dosage schema of colchicine and twice daily dosage schema of colchicine
Also known as: colchicum
Mor severity scoring system
The primary objectives of this study were to compare the effectiveness of once and twice daily colchicine dosage regimens regarding taking control of disease symptoms which can be reducing disease severity which was assessed by modified Mor scoring system and
Time frame: At baseline and every 12 weeks, up to 24 weeks. Change in disease severity as assessed by the Mor severity scoring system.
Adverse events
Adverse Events That Are Related to Treatment
Time frame: up to 24 weeks
Number of Participants With Abnormal Laboratory Values
Laboratory findings such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), serum amyloid A (SAA) levels were used for the indication of inflammation.
Time frame: At baseline and every 12 weeks, up to 24 weeks.
The record gives a start of Apr 2011, a primary completion of Apr 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Colchicine
Familial Mediterranean Fever →
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi