Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France

NCT05964946 | Completed

• 1 other identifier: CACZ885HFR01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This was a non-interventional, retrospective, cross-sectional, descriptive study, conducted on the National Health Data System (Système National des Données de Santé, SNDS). The study did not modify the doctor-patient relationship, nor the management or follow-up of patients. Patients with dispensation of canakinumab for gouty arthritis were selected over the period from 08 April 2018 to 07 April 2020; index date was defined as date of the first dispensation of canakinumab in community pharmacy during study period. Patients were described at index date. Medical history and comorbidities, and previous treatments for gouty arthritis were assessed during 3 years prior to index date. Co-treatments of interest for which standard treatments for gouty arthritis were contraindicated or required precautions for use were assessed during 6 months prior to index date.

Conditions

Gouty Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of patients treated with canakinumab in France for the treatment of gouty arthritis

  2 years

Secondary Outcomes (6)

• Mean age of patients

  3 years

• Number of male patients

  3 years

• Geographic location of patients

  3 years

• Number of patients with previous treatments for gouty arthritis

  3 years

• Medical history of patients

  3 years

Eligibility Criteria

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

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• Received at least one reimbursement of Ilaris® from 08 April 2018 to 07 April 2020.
• Benefited from at least one of the following healthcare consumptions during 3 years prior to index date:
• o At least one hospitalization with a main diagnosis or a related diagnosis in a Medical Unit Summary or a significant associated diagnosis in a Standardized Discharge Summary corresponding to the International Classification of Diseases, 10th Revision (ICD-10) code:
• M10.0 "Idiopathic gout"
• M10.1 "Saturnine gout"
• M10.2 "Medicated gout"
• M10.3 "Gout due to impaired renal function"
• M10.4 "Other secondary gout"
• M10.9 "Gout, unspecified"
• And/or an active long-term disease (Affection Longue Durée, ALD) with an ICD-10 code: "M10 Gout"
• And/or at least one dispensation of colchicine and urate-lowering therapy (allopurinol and/or febuxostat and/or benzbromarone and/or probenecid) at any time.

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

Paris, 92506, France

Location

MeSH Terms

Conditions

Arthritis, Gouty

Condition Hierarchy (Ancestors)

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: June 24, 2020
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

FR (1)