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

NCT07517250 | Recruiting

• 1 other identifier: CACZ885G2005
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (9)

• Percentage of Patients With Clinically Inactive Disease Under Treatment With Canakinumab Received in First or Second or More Lines of Treatment With Biologic Agents

  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.

  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.

  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.

  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.

  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.

  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.

  Up to 3 years

• Percentage of Patients who are Taking Canakinumab and Stopped or Significantly Tapered Administration of Steroids

  Up to 3 years

• Percentage of Patients who Discontinued Canakinumab 6 Months After Initiation by Reason for Discontinuation

  6 months

Secondary Outcomes (29)

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

  Up to 3 years

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

  Up to 3 years

• Percentage of Patients who Switch From Anakinra or Tocilizumab to Canakinumab

  Up to 3 years

• Time to Switch From Anakinra or Tocilizumab to Canakinumab

  Up to 3 years

• Percentage of Patients by Reason for Switching From Anakinra or Tocilizumab to Canakinumab Treatment

  Up to 3 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients Aged \<2 Years (24 Months) at Index Date.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

Basel, Switzerland

RECRUITING

MeSH Terms

Conditions

Familial Mediterranean Fever; Arthritis, Juvenile; Still's Disease, Adult-Onset

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis, Rheumatoid

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)