A Phase 2 interventional study of Canakinumab in Familial Mediterranean Fever, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Turkey. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-05-01.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 10th largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2010, is one of 3 in phase 2, and was the 3rd 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: 12 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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. 2 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below 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.
This tab as a report to print or save as PDF → With an account.
5 of 20 have an industry lead sponsor. The 10 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis has 4 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 |
Add it to your calendar (.ics) → With an account.
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.
This tab as a report to print or save as PDF → With an account.
Establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever.
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:
Other protocol-defined inclusion/exclusion criteria may apply
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.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Canakinumab
To measure the effect of canakinumab on the frequency of FMF attacks defined as percentage of patients with at least 50% reduction in the attack frequency during 3 month treatment period.
Time frame: 12 weeks
To assess the effect of canakinumab with regard to percentage of patients with no attacks in month 3.
Time frame: 12 weeks
To find the optimal dose of canakinumab for FMF in this population
Time frame: 12 weeks
To assess changes in the severity (acute phase response and VAS evaluation of attack severity by patient) and duration of acute attacks during the treatment period
Time frame: 12 weeks
To assess PK/PD properties of canakinumab by measuring canakinumab and IL-1beta levels before dosing
To evaluate the safety and tolerability of canakinumab by monitoring adverse events and patient discontinuations due to AE
The record gives a start of Apr 2010, a primary completion of Aug 2011 and a completion of Aug 2011. 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 Apr 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Canakinumab
Familial Mediterranean Fever →