A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Pediatric and adult patients prescribed canakinumab for at least 6 months for the treatment of FMF or Still's disease.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

160 Participants
are grouped into 3 trial groups
Group A: FMF Cohort
Group B: SJIA Cohort
Group C: AOSD Cohort

Trial outcomes

Primary outcomes

1

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
2

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.

Time frame
Up to 3 years
3

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.

Time frame
Up to 3 years
4

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.

Time frame
Up to 3 years

Secondary outcomes

1

Percentage of Patients Using Anakinra, Tocilizumab and Canakinumab as First, Second or Posterior Line of Treatment

Time frame
Up to 3 years
2

Percentage of Patients Using Colchicine Only or Corticosteroids as First Line of Treatment

Time frame
Up to 3 years
3

Percentage of Patients who Switch From Anakinra or Tocilizumab to Canakinumab

Time frame
Up to 3 years
4

Time to Switch From Anakinra or Tocilizumab to Canakinumab

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

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