Familial Mediterranean FeverNCT07517250
A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients
An observational study of Familial Mediterranean Fever and Still Disease, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
This study aims to assess and characterize the treatment patterns, and long-term clinical outcomes and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease (including systemic juvenile idiopathic arthritis [SJIA] and adult-onset Still's disease [AOSD]) that… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Familial Mediterranean Fever, Still Disease, Systemic Juvenile Idiopathic Arthritis
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Mar 2026to 3 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult patients prescribed canakinumab for at least 6 months for the treatment of FMF or Still's disease.
Who may be able to join
- Pediatric or adult patients who were prescribed canakinumab before October 2021 and received canakinumab for at least 6 months for the treatment of FMF or Still's disease (including SJIA or AOSD).
- Have data on clinical characteristics and treatments available for at least 3 years following the initiation of canakinumab treatment.
Who cannot join
- Patients Aged <2 Years (24 Months) at Index Date.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: Non-interventional Study on the Use of ILARIS® (Canakinumab) Among Familial Mediterranean Fever and Still's Disease Patients Across Europe and Israel
This study aims to assess and characterize the treatment patterns, and long-term clinical outcomes and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease (including systemic juvenile idiopathic arthritis [SJIA] and adult-onset Still's disease [AOSD]) that received canakinumab for at least 6 months.
- Conditions
- Familial Mediterranean Fever, Still Disease, Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still Disease
- Keywords
- Canakinumab, Real-world evidence study, Treatment patterns, Clinical outcomes, Patient quality of life, Pediatric and adult patients
- Medical subject headings
- Familial Mediterranean Fever, Arthritis, Juvenile, Still's Disease, Adult-Onset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FMF Cohort | Patients diagnosed with FMF that received canakinumab for at least 6 months. | |
| SJIA Cohort | Patients diagnosed with SJIA that received canakinumab for at least 6 months. | |
| AOSD Cohort | Patients diagnosed with AOSD that received canakinumab for at least 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Measured: Up to 3 years
Percentage of Patients With Partial Remission Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Partial remission is defined as a significant clinical and laboratory improvement according to the attending physician's opinion or clinical remission with remaining laboratory activity.
Measured: Up to 3 years
Percentage of Patients With Complete Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.
Measured: Up to 3 years
Percentage of Patients With Partial Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Partial response is defined as persistence of clinical manifestations with remarkable decrease in their severity and/or inflammatory laboratory parameters normalized or only slightly increased.
Measured: Up to 3 years
Percentage of Patients With Poor Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Poor response is defined as not meeting the definitions of clinically inactive disease and partial remission.
Measured: Up to 3 years
Percentage of Patients With Clinically Inactive FMF Disease After Completing Treatment With Canakinumab
Clinically inactive disease is defined as no active clinical symptoms, normal acute phase reactants, and normal disease activity scores.
Measured: Up to 3 years
Percentage of Patients With Complete Remission/Response in Still's Disease After Completing Treatment With Canakinumab
Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.
Measured: Up to 3 years
Percentage of Patients who are Taking Canakinumab and Stopped or Significantly Tapered Administration of Steroids
Measured: Up to 3 years
Percentage of Patients who Discontinued Canakinumab 6 Months After Initiation by Reason for Discontinuation
Measured: 6 months
Secondary outcomes (29)
Percentage of Patients Using Anakinra, Tocilizumab and Canakinumab as First, Second or Posterior Line of Treatment
Measured: Up to 3 years
Percentage of Patients Using Colchicine Only or Corticosteroids as First Line of Treatment
Measured: Up to 3 years
Percentage of Patients who Switch From Anakinra or Tocilizumab to Canakinumab
Measured: Up to 3 years
Time to Switch From Anakinra or Tocilizumab to Canakinumab
Measured: Up to 3 years
Percentage of Patients by Reason for Switching From Anakinra or Tocilizumab to Canakinumab Treatment
Measured: Up to 3 years
Percentage of Patients by Dosing Regimen
Measured: Up to 3 years
Time From Disease Onset to Prescription of First Biologic Treatment
Measured: Up to 3 years
Time From Diagnosis to Prescription of First Biologic Treatment
Measured: Up to 3 years
Percentage of Patients by Concomitant Treatments Received Before Canakinumab Treatment
Measured: 12 months
Percentage of Patients by Concomitant Treatments Received During Canakinumab Treatment
Measured: Up to 3 years
Percentage of Patients With Hospitalizations Before Canakinumab Treatment
Hospitalizations include emergency room visits and hospital admissions.
Measured: 12 months
Percentage of Patients With Hospitalizations During Canakinumab Treatment
Hospitalizations include emergency room visits and hospital admissions.
Measured: Up to 3 years
Number of Hospitalizations Per Year Before Canakinumab Treatment
Hospitalizations include emergency room visits and hospital admissions.
Measured: 12 months
Number of Hospitalizations Per Year During Canakinumab Treatment
Hospitalizations include emergency room visits and hospital admissions.
Measured: Up to 3 years
Total Length of Hospital Stay Per Year Before Canakinumab Treatment
Hospital stays include general ward and intensive care unit.
Measured: 12 months
Total Length of Hospital Stay Per Year During Canakinumab Treatment
Hospital stays include general ward and intensive care unit.
Measured: Up to 3 years
Percentage of Patients With Medical Visits Before Canakinumab Treatment
Percentage of patients with medical visits, stratified by physician specialty.
Measured: 12 months
Percentage of Patients With Medical Visits During Canakinumab Treatment
Percentage of patients with medical visits, stratified by physician specialty.
Measured: Up to 3 years
Number of Medical Visits Per Year Before Canakinumab Treatment
Number of medical visits per year, stratified by physician specialty.
Measured: 12 months
Number of Medical Visits Per Year During Canakinumab Treatment
Number of medical visits per year, stratified by physician specialty.
Measured: Up to 3 years
Percentage of Patients With Diagnostic Tests Before Canakinumab Treatment
Percentage of patients with diagnostic tests, stratified by type of test.
Measured: 12 months
Percentage of Patients With Diagnostic Tests During Canakinumab Treatment
Percentage of patients with diagnostic tests, stratified by type of test.
Measured: Up to 3 years
Number of Diagnostic Tests Per Year Before Canakinumab Treatment
Number of diagnostic tests per year, stratified by type of test.
Measured: 12 months
Number of Diagnostic Tests Per Year During Canakinumab Treatment
Number of diagnostic tests per year, stratified by type of test.
Measured: Up to 3 years
Percentage of Patients With Laboratory Tests Before Canakinumab Treatment
Percentage of patients with laboratory tests, stratified by type of test.
Measured: 12 months
Percentage of Patients With Laboratory Tests During Canakinumab Treatment
Percentage of patients with laboratory tests, stratified by type of test.
Measured: Up to 3 years
Number of Laboratory Tests Per Year Before Canakinumab Treatment
Number of laboratory tests per year, stratified by type of test.
Measured: 12 months
Number of Laboratory Tests Per Year During Canakinumab Treatment
Number of laboratory tests per year, stratified by type of test.
Measured: Up to 3 years
Quality of Life Scale Score
This analysis will be done if a minimum of 30 patients with the same patient-reported outcome (PRO) and same version are available in the medical charts.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start15 Mar 2026
- Primary completion3 Dec 2026 (estimated)
- Study completion3 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517250
- Sponsor's protocol ID
- CACZ885G2005
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study on the Use of ILARIS® (Canakinumab) Among Familial Mediterranean Fever and Still's Disease Patients Across Europe and Israel
- ClinicalTrials.gov ID
- NCT07517250
- Acronym / sponsor ID
- CACZ885G2005
- Conditions
- Familial Mediterranean Fever, Still Disease, Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still Disease
- Keywords
- Canakinumab, Real-world evidence study, Treatment patterns, Clinical outcomes, Patient quality of life, Pediatric and adult patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 3 Dec 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess and characterize the treatment patterns, and long-term clinical outcomes and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease (including systemic juvenile idiopathic arthritis [SJIA] and adult-onset Still's disease [AOSD]) that received canakinumab for at least 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FMF Cohort | – | –Patients diagnosed with FMF that received canakinumab for at least 6 months. |
| SJIA Cohort | – | –Patients diagnosed with SJIA that received canakinumab for at least 6 months. |
| AOSD Cohort | – | –Patients diagnosed with AOSD that received canakinumab for at least 6 months. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients prescribed canakinumab for at least 6 months for the treatment of FMF or Still's disease.
Key inclusion criteria (2 listed)
- Pediatric or adult patients who were prescribed canakinumab before October 2021 and received canakinumab for at least 6 months for the treatment of FMF or Still's disease (including SJIA or AOSD).
- Have data on clinical characteristics and treatments available for at least 3 years following the initiation of canakinumab treatment.
Key exclusion criteria (1 listed)
- Patients Aged <2 Years (24 Months) at Index Date.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Time frame: Up to 3 years
Percentage of Patients With Partial Remission Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Time frame: Up to 3 years
Partial remission is defined as a significant clinical and laboratory improvement according to the attending physician's opinion or clinical remission with remaining laboratory activity.
Percentage of Patients With Complete Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Time frame: Up to 3 years
Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.
Percentage of Patients With Partial Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Time frame: Up to 3 years
Partial response is defined as persistence of clinical manifestations with remarkable decrease in their severity and/or inflammatory laboratory parameters normalized or only slightly increased.
Percentage of Patients With Poor Response Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents
Time frame: Up to 3 years
Poor response is defined as not meeting the definitions of clinically inactive disease and partial remission.
Percentage of Patients With Clinically Inactive FMF Disease After Completing Treatment With Canakinumab
Time frame: Up to 3 years
Clinically inactive disease is defined as no active clinical symptoms, normal acute phase reactants, and normal disease activity scores.
Percentage of Patients With Complete Remission/Response in Still's Disease After Completing Treatment With Canakinumab
Time frame: Up to 3 years
Complete response is defined as the complete resolution of all disease-related clinical manifestations with decrease of all laboratory inflammatory parameters within normal values.
Percentage of Patients who are Taking Canakinumab and Stopped or Significantly Tapered Administration of Steroids
Time frame: Up to 3 years
Percentage of Patients who Discontinued Canakinumab 6 Months After Initiation by Reason for Discontinuation
Time frame: 6 months
29 secondary outcomes
Percentage of Patients Using Anakinra, Tocilizumab and Canakinumab as First, Second or Posterior Line of Treatment
Time frame: Up to 3 years
Percentage of Patients Using Colchicine Only or Corticosteroids as First Line of Treatment
Time frame: Up to 3 years
Percentage of Patients who Switch From Anakinra or Tocilizumab to Canakinumab
Time frame: Up to 3 years
Time to Switch From Anakinra or Tocilizumab to Canakinumab
Time frame: Up to 3 years
Percentage of Patients by Reason for Switching From Anakinra or Tocilizumab to Canakinumab Treatment
Time frame: Up to 3 years
Percentage of Patients by Dosing Regimen
Time frame: Up to 3 years
Time From Disease Onset to Prescription of First Biologic Treatment
Time frame: Up to 3 years
Time From Diagnosis to Prescription of First Biologic Treatment
Time frame: Up to 3 years
Percentage of Patients by Concomitant Treatments Received Before Canakinumab Treatment
Time frame: 12 months
Percentage of Patients by Concomitant Treatments Received During Canakinumab Treatment
Time frame: Up to 3 years
Percentage of Patients With Hospitalizations Before Canakinumab Treatment
Time frame: 12 months
Percentage of Patients With Hospitalizations During Canakinumab Treatment
Time frame: Up to 3 years
Number of Hospitalizations Per Year Before Canakinumab Treatment
Time frame: 12 months
Number of Hospitalizations Per Year During Canakinumab Treatment
Time frame: Up to 3 years
Total Length of Hospital Stay Per Year Before Canakinumab Treatment
Time frame: 12 months
Total Length of Hospital Stay Per Year During Canakinumab Treatment
Time frame: Up to 3 years
Percentage of Patients With Medical Visits Before Canakinumab Treatment
Time frame: 12 months
Percentage of Patients With Medical Visits During Canakinumab Treatment
Time frame: Up to 3 years
Number of Medical Visits Per Year Before Canakinumab Treatment
Time frame: 12 months
Number of Medical Visits Per Year During Canakinumab Treatment
Time frame: Up to 3 years
Percentage of Patients With Diagnostic Tests Before Canakinumab Treatment
Time frame: 12 months
Percentage of Patients With Diagnostic Tests During Canakinumab Treatment
Time frame: Up to 3 years
Number of Diagnostic Tests Per Year Before Canakinumab Treatment
Time frame: 12 months
Number of Diagnostic Tests Per Year During Canakinumab Treatment
Time frame: Up to 3 years
Percentage of Patients With Laboratory Tests Before Canakinumab Treatment
Time frame: 12 months
Percentage of Patients With Laboratory Tests During Canakinumab Treatment
Time frame: Up to 3 years
Number of Laboratory Tests Per Year Before Canakinumab Treatment
Time frame: 12 months
Number of Laboratory Tests Per Year During Canakinumab Treatment
Time frame: Up to 3 years
Quality of Life Scale Score
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Mediterranean Fever and Still Disease, run by Novartis Pharmaceuticals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents (time frame: Up to 3 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.