Familial Mediterranean FeverNCT06923124
A Study to Describe a Group of Spanish Patients With FMF and to Identify Suboptimally Treated Patients With Minimal Disease Activity and Its Impact on Quality of Life
An observational study of Familial Mediterranean Fever, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
A retrospective, non-interventional, single-center study conducted in Spain, based on the collection of data from the medical histories of patients with Familial Mediterranean fever (FMF) diagnosed during childhood from January 2005 to December 2021. Read more about this study
- Who is it for?
- Ages Up to 28 years
- Conditions the study is for
- Familial Mediterranean Fever
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 28 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This was a retrospective, non-interventional cohort study.
Who may be able to join
- Patients with FMF clinically and/or genetically diagnosed during childhood according to the site's clinical practice.
- Patients with at least 3 months of follow-up from the date of diagnosis, at the time of their enrollment in the study.
Who cannot join
- Patients with autoinflammatory disease excluding FMF.
- Patients with recurrent fever of another etiology (infectious, tumor or other).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Non-interventional, Single-center Study to Describe a Spanish Cohort of Patients With FMF and to Identify Suboptimally Treated Patients With Minimal Disease Activity and Its Impact on HRQoL (Health-Related Quality of Life)
A retrospective, non-interventional, single-center study conducted in Spain, based on the collection of data from the medical histories of patients with Familial Mediterranean fever (FMF) diagnosed during childhood from January 2005 to December 2021.
Data from the patients' medical records was collected retrospectively, from the time of diagnosis to the current moment of the patient's enrollment in the study. Patients had a minimum follow-up of 3 months after diagnosis.
- Conditions
- Familial Mediterranean Fever
- Medical subject headings
- Familial Mediterranean Fever
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 | Spanish patients diagnosed with FMF during childhood from January 2005 to December 2021. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients per Clinical Characteristic Category
Clinical characteristic categories included:
- Diagnostic criteria of FMF (symptom associated with FMF, without a proven infectious cause, with a recurrent pattern and/or accompanied by a genetic test suggestive of Mediterranean FeVer gene [MEFV])
- Family history of FMF
- MEFV genotypes
- Phenotypes of interleukin-1 (IL-1) mediated autoinflammatory disease
- Diagnosis prior to FMF
Measured: Baseline
Clinical Characteristic: Time From FMF Diagnosis to Study Inclusion
Measured: Baseline
Clinical Characteristic: Time From the Start of Symptomatology to Study Inclusion
Measured: Baseline
Clinical Characteristic: Time From the Start of Symptomatology to FMF Diagnosis
Measured: Baseline
Clinical Characteristic: Age at the Start of Symptomatology
Measured: Baseline
Number of Patients by Symptomatology
Symptoms included:
- Abdominal pain
- Arthralgia
- Myalgia
- Articulatory inflammation
- Chest pain
- Rash
- Fatigue
- Symptoms compatible with Periodic Fever, Aphthous stomatitis, Pharyngitis and Adenitis (PFAPA)
- Other
Measured: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Number of Patients by Characteristics of Relapses (Flares)
Relapse characteristics included:
- Fever: high (> 38C), low (≤ 38C), no fever
- Relapse frequency (<1 or ≥1 relapse per month for 3 months)
- Presence of triggers
- Presence of complications
- Flare and non-flare related inflammatory markers: C-reactive protein (CRP), serum amyloid A protein (SAA), and erythrocyte sedimentation rate (ESR)
- Disease remission
Measured: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Flare and Non-flare Related Inflammatory Marker Levels
Inflammatory markers included CRP and SAA.
Measured: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Flare and Non-flare Related Erythrocyte Sedimentation Rate (ESR)
Measured: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Number of Flares per Month Since Last Visit
Measured: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Flare Duration Since Last Visit
Measured: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Number of Patients With Recurrency of Flares at Diagnosis
Measured: Baseline
Number of Patients by Comorbidity
Comorbidities included vasculitis, panniculitis, inflammatory bowel disease, psoriasis, celiac disease, autoimmune disease, other inflammatory diseases, juvenile idiopathic arthritis, multiple sclerosis, attention deficit hyperactivity disorder (ADHD), and other.
Measured: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Number of Patients by Treatment Received Before FMF Diagnosis
Treatments included:
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Corticoids
- Colchicine
- Anti-IL-1
- Other
Measured: Baseline
Number of Patients by Treatment Received At Least Once During the Study
Treatments included:
- Colchicine
- Canakinumab
- Anakinra
- Corticoids
- Methotrexate (MTX)
- Anti-IL-6
- Anti-tumor necrosis factor (TNF)
Measured: Up to 11 years
Number of Patients by Treatment and Treatment Combinations Used at the end of the Study
Treatments and treatment combinations included:
- Colchicine
- Canakinumab
- Anakinra
- Corticoids
- MTX
- Anti-IL-6
- Anti-TNF
- Colchicine / Canakinumab
- Colchicine / Corticoids
- Anakinra
- Canakinumab
- Colchicine / Anti-TNF
- Colchicine / MTX / Anti-IL- 6
Measured: Up to 11 years
Number of Patients Using Colchicine With Another Treatment at the end of the Study
Measured: Up to 11 years
Number of Patients by First Prescribed Colchicine Dose and Age Group
Measured: Up to 11 years
Number of Patients by Colchicine Maximum Global Dose and Age Group
Measured: Up to 11 years
Number of Patients With a Change in Colchicine Dose
Measured: Up to 11 years
Number of Patients by Reason for Stopping Colchicine Treatment and Age Group
Measured: Up to 11 years
Number of Patients by Anti-IL-1 Treatment Used at the end of the Study
Anti-IL-1 treatment included canakinumab and anakinra.
Measured: Up to 11 years
Number of Patients by Anti-IL-1 Dose at the end of the Study
Measured: Up to 11 years
Number of Patients With a Change in Anti-IL-1 Dose
Measured: Up to 11 years
Number of Patients With a Change in Anti-IL-1 Treatment
Changes in treatment included:
- Change of treatment to a treatment of the same family (anti-IL-1)
- Change of treatment to a treatment of another family
Measured: Up to 11 years
Number of Patients by Reason for Stopping Anti-IL-1 Treatment
Measured: Up to 11 years
Secondary outcomes (18)
Number of Patients by Last Reported Response to Colchicine Treatment
Responses included:
- Complete response: absence of clinical manifestations and normal CRP/SAA levels.
- Partial response: <1 flare/month or persistent high CRP/SAA levels with maximum tolerated dose of colchicine or partial response with unknown frequency.
- Resistant: ≥1 flare/month or persistent high CRP/SAA levels with maximum tolerated dose of colchicine.
- Intolerant: intolerance to treatment as reason for stopping colchicine treatment or changing to another treatment.
Measured: Up to 11 years
Time to Achieve Response to Colchicine Treatment
Time to achieve first complete response, complete response, and complete response maintenance were measured.
Measured: Up to 11 years
Number of Patients With Intolerance to Colchicine Treatment
Measured: Up to 11 years
Autoinflammatory Disease Activity Index (AIDAI) Score
The AIDAI is an assessment tool used to evaluate the level of disease activity. The AIDAI for FMF includes 7 variables: fever, abdominal pain, chest pain, arthralgia or myalgia, swelling of the joints, skin rash, and pain relief taken. Disease activity scores are calculated from the daily scores collected in a patient diary completed during flares. Fever is scored as 0 (absent) or present (1), with all other clinical variables scored from 0 (absent) to 3 (severe). Pain relief taken is not included in the disease activity score calculation. A higher total score indicates a higher level of disease activity.
AIDAI was used to assess the association between disease activity and colchicine resistance/intolerance, response to canakinumab treatment, pain, fatigue, and quality of life (absenteeism at school during flares, limitation of physical activity, psychological care, and overall health status).
Measured: Up to 11 years
Autoinflammatory Disease Damage Index (ADDI) Score
The ADDI is an assessment tool used to evaluate the level of damage caused by autoinflammatory disease. It consists of 18 damage items grouped by organ system: reproductive, renal/amyloidosis, developmental, serosal, neurological, ears, ocular and musculoskeletal damage. Each damage item is defined and assigned a score of 1, 2, or 3, with each organ system having a maximum allowed score. A higher total score indicates a higher level of damage.
ADDI was used to assess the association between disease damage and colchicine resistance/intolerance, response to canakinumab treatment, pain, fatigue, and quality of life (absenteeism at school during flares, limitation of physical activity, psychological care, and overall health status).
Measured: Up to 11 years
Familial Mediterranean Fever 50 (FMF50) Score
The FMF50 is an assessment tool used to evaluate response to treatment for FMF. It consists of 6 items:
- Percentage change in the frequency of attacks with the treatment.
- Percentage change in the duration of attacks with the treatment.
- Patients/parents' global assessment of disease severity.
- Physicians' global assessment of disease severity.
- Percentage change in arthritis attacks with the treatment.
- Percentage change in CRP, ESR, or SAA level with the treatment. An improvement of at least 50% in 5 of the 6 items without worsening in any one item indicates that the patient is responding to treatment.
FMF50 was used to assess response to canakinumab treatment and the association between response to treatment and colchicine resistance/intolerance, pain, fatigue, and quality of life (absenteeism at school during flares, limitation of physical activity, psychological care, and overall health status).
Measured: Up to 11 years
Number of Patients by Last Response Reported to Anti-IL-1 Treatment During the Study
Responses included:
- Complete response: absence of clinical manifestations and normal CRP/SAA levels.
- Incomplete response: persistent febrile episodes or high CRP/SAA levels
- Partial response: <1 flare/month or persistent high CRP/SAA levels with maximum tolerated dose of colchicine or partial response with unknown frequency.
- Resistant: ≥1 flare/month or persistent high CRP/SAA levels with maximum tolerated dose of colchicine.
Anti-IL-1 treatments included canakinumab and anakinra.
Measured: Up to 11 years
Time to Achieve Response to Anti-IL-1 Treatment
Time to achieve complete response and complete response maintenance were measured. Anti-IL-1 treatments included canakinumab and anakinra.
Measured: Up to 11 years
Number of Patients With MEFV Mutation by Treatment Response
Response categories included:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Number of Patients Without MEFV Mutation by Treatment Response
Response categories included:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Number of Patients With Mutation in Other Loci by Treatment Response
Response categories included:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Number of Medical Visits of Patients With Scholar Absenteeism During Flares by Response to Anti-IL-1 Treatment
Anti-IL-1 treatments included canakinumab and anakinra. Responses were categorized as follows:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Number of Medical Visits of Patients With Physical Activity Limitations by Response to Anti-IL-1 Treatment
Anti-IL-1 treatments included canakinumab and anakinra. Responses were categorized as follows:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Number of Medical Visits of Patients Requiring Psychological Care by Response to Anti-IL-1 Treatment
Anti-IL-1 treatments included canakinumab and anakinra. Responses were categorized as follows:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Number of Medical Visits of Patients With Presence of Pain by Response to Anti-IL-1 Treatment
Anti-IL-1 treatments included canakinumab and anakinra. Responses were categorized as follows:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Number of Medical Visits of Patients With Presence of Fatigue by Response to Anti-IL-1 Treatment
Anti-IL-1 treatments included canakinumab and anakinra. Responses were categorized as follows:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Visual Analogue Scale (VAS) Score From Clinician Point of View
Patients' overall state of health was assessed using VAS scoring. The VAS is a straight line with a scale ranging from 0 (worst health) to 10 (best health). The clinician marks a point on the line, scoring how they perceive the patient's overall state of health.
VAS was used to assess the association between anti-IL-1 treatment response and overall state of health. Anti-IL-1 treatments included canakinumab and anakinra. Treatment response was categorized as follows:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Visual Analogue Scale (VAS) Score From Patient Point of View
Patients' overall state of health was assessed using VAS scoring. The VAS is a straight line with a scale ranging from 0 (worst health) to 10 (best health). Patients mark a point on the line, scoring how they perceive their overall state of health.
VAS was used to assess the association between anti-IL-1 treatment response and overall state of health. Anti-IL-1 treatments included canakinumab and anakinra. Treatment response was categorized as follows:
- Respondent: without flares and with normal inflammatory markers in the last 3 months.
- Non-respondent: with flare and/or elevated inflammatory markers in the last 3 months.
- Partial respondent: did not fulfill some of the criteria for complete response.
Measured: Up to 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start30 Mar 2023
- Primary completion28 May 2024
- Study completion28 May 2024
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
- 44 participants (actual)
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
- NCT06923124
- Sponsor's protocol ID
- CACZ885NES01R
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Non-interventional, Single-center Study to Describe a Spanish Cohort of Patients With FMF and to Identify Suboptimally Treated Patients With Minimal Disease Activity and Its Impact on HRQoL (Health-Related Quality of Life)
- ClinicalTrials.gov ID
- NCT06923124
- Acronym / sponsor ID
- CACZ885NES01R
- Conditions
- Familial Mediterranean Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 11 Apr 2025 (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.
A retrospective, non-interventional, single-center study conducted in Spain, based on the collection of data from the medical histories of patients with Familial Mediterranean fever (FMF) diagnosed during childhood from January 2005 to December 2021.
Data from the patients' medical records was collected retrospectively, from the time of diagnosis to the current moment of the patient's enrollment in the study. Patients had a minimum follow-up of 3 months after diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMF Cohort | – | –Spanish patients diagnosed with FMF during childhood from January 2005 to December 2021. |
Who may qualify
- Ages
- Up to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This was a retrospective, non-interventional cohort study.
Key inclusion criteria (2 listed)
- Patients with FMF clinically and/or genetically diagnosed during childhood according to the site's clinical practice.
- Patients with at least 3 months of follow-up from the date of diagnosis, at the time of their enrollment in the study.
Key exclusion criteria (2 listed)
- Patients with autoinflammatory disease excluding FMF.
- Patients with recurrent fever of another etiology (infectious, tumor or other).
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
Number of Patients per Clinical Characteristic Category
Time frame: Baseline
Clinical characteristic categories included: * Diagnostic criteria of FMF (symptom associated with FMF, without a proven infectious cause, with a recurrent pattern and/or accompanied by a genetic test suggestive of Mediterranean FeVer gene [MEFV]) * Family history of FMF * MEFV genotypes * Phenotypes of interleukin-1 (IL-1) mediated autoinflammatory disease * Diagnosis prior to FMF
Clinical Characteristic: Time From FMF Diagnosis to Study Inclusion
Time frame: Baseline
Clinical Characteristic: Time From the Start of Symptomatology to Study Inclusion
Time frame: Baseline
Clinical Characteristic: Time From the Start of Symptomatology to FMF Diagnosis
Time frame: Baseline
Clinical Characteristic: Age at the Start of Symptomatology
Time frame: Baseline
Number of Patients by Symptomatology
Time frame: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Symptoms included: * Abdominal pain * Arthralgia * Myalgia * Articulatory inflammation * Chest pain * Rash * Fatigue * Symptoms compatible with Periodic Fever, Aphthous stomatitis, Pharyngitis and Adenitis (PFAPA) * Other
Number of Patients by Characteristics of Relapses (Flares)
Time frame: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Relapse characteristics included: * Fever: high (> 38C), low (≤ 38C), no fever * Relapse frequency (<1 or ≥1 relapse per month for 3 months) * Presence of triggers * Presence of complications * Flare and non-flare related inflammatory markers: C-reactive protein (CRP), serum amyloid A protein (SAA), and erythrocyte sedimentation rate (ESR) * Disease remission
Flare and Non-flare Related Inflammatory Marker Levels
Time frame: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Inflammatory markers included CRP and SAA.
Flare and Non-flare Related Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Number of Flares per Month Since Last Visit
Time frame: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Flare Duration Since Last Visit
Time frame: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Number of Patients With Recurrency of Flares at Diagnosis
Time frame: Baseline
Number of Patients by Comorbidity
Time frame: Baseline, Month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132
Comorbidities included vasculitis, panniculitis, inflammatory bowel disease, psoriasis, celiac disease, autoimmune disease, other inflammatory diseases, juvenile idiopathic arthritis, multiple sclerosis, attention deficit hyperactivity disorder (ADHD), and other.
Number of Patients by Treatment Received Before FMF Diagnosis
Time frame: Baseline
Treatments included: * Non-steroidal anti-inflammatory drugs (NSAIDs) * Corticoids * Colchicine * Anti-IL-1 * Other
Number of Patients by Treatment Received At Least Once During the Study
Time frame: Up to 11 years
Treatments included: * Colchicine * Canakinumab * Anakinra * Corticoids * Methotrexate (MTX) * Anti-IL-6 * Anti-tumor necrosis factor (TNF)
Number of Patients by Treatment and Treatment Combinations Used at the end of the Study
Time frame: Up to 11 years
Treatments and treatment combinations included: * Colchicine * Canakinumab * Anakinra * Corticoids * MTX * Anti-IL-6 * Anti-TNF * Colchicine / Canakinumab * Colchicine / Corticoids * Anakinra * Canakinumab * Colchicine / Anti-TNF * Colchicine / MTX / Anti-IL- 6
Number of Patients Using Colchicine With Another Treatment at the end of the Study
Time frame: Up to 11 years
Number of Patients by First Prescribed Colchicine Dose and Age Group
Time frame: Up to 11 years
Number of Patients by Colchicine Maximum Global Dose and Age Group
Time frame: Up to 11 years
Number of Patients With a Change in Colchicine Dose
Time frame: Up to 11 years
Number of Patients by Reason for Stopping Colchicine Treatment and Age Group
Time frame: Up to 11 years
Number of Patients by Anti-IL-1 Treatment Used at the end of the Study
Time frame: Up to 11 years
Anti-IL-1 treatment included canakinumab and anakinra.
Number of Patients by Anti-IL-1 Dose at the end of the Study
Time frame: Up to 11 years
Number of Patients With a Change in Anti-IL-1 Dose
Time frame: Up to 11 years
Number of Patients With a Change in Anti-IL-1 Treatment
Time frame: Up to 11 years
Changes in treatment included: * Change of treatment to a treatment of the same family (anti-IL-1) * Change of treatment to a treatment of another family
Number of Patients by Reason for Stopping Anti-IL-1 Treatment
Time frame: Up to 11 years
18 secondary outcomes
Number of Patients by Last Reported Response to Colchicine Treatment
Time frame: Up to 11 years
Time to Achieve Response to Colchicine Treatment
Time frame: Up to 11 years
Number of Patients With Intolerance to Colchicine Treatment
Time frame: Up to 11 years
Autoinflammatory Disease Activity Index (AIDAI) Score
Time frame: Up to 11 years
Autoinflammatory Disease Damage Index (ADDI) Score
Time frame: Up to 11 years
Familial Mediterranean Fever 50 (FMF50) Score
Time frame: Up to 11 years
Number of Patients by Last Response Reported to Anti-IL-1 Treatment During the Study
Time frame: Up to 11 years
Time to Achieve Response to Anti-IL-1 Treatment
Time frame: Up to 11 years
Number of Patients With MEFV Mutation by Treatment Response
Time frame: Up to 11 years
Number of Patients Without MEFV Mutation by Treatment Response
Time frame: Up to 11 years
Number of Patients With Mutation in Other Loci by Treatment Response
Time frame: Up to 11 years
Number of Medical Visits of Patients With Scholar Absenteeism During Flares by Response to Anti-IL-1 Treatment
Time frame: Up to 11 years
Number of Medical Visits of Patients With Physical Activity Limitations by Response to Anti-IL-1 Treatment
Time frame: Up to 11 years
Number of Medical Visits of Patients Requiring Psychological Care by Response to Anti-IL-1 Treatment
Time frame: Up to 11 years
Number of Medical Visits of Patients With Presence of Pain by Response to Anti-IL-1 Treatment
Time frame: Up to 11 years
Number of Medical Visits of Patients With Presence of Fatigue by Response to Anti-IL-1 Treatment
Time frame: Up to 11 years
Visual Analogue Scale (VAS) Score From Clinician Point of View
Time frame: Up to 11 years
Visual Analogue Scale (VAS) Score From Patient Point of View
Time frame: Up to 11 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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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. This study is not recruiting at the moment.
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, run by Novartis Pharmaceuticals at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 11 Apr 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients per Clinical Characteristic Category (time frame: Baseline). The study lists 26 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 11 Apr 2025.