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OpenTrials
Completed

NCT Number: NCT05964946

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Paris, 92506, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. Mean age of patients

    Time frame: 3 years

  2. Number of male patients

    Time frame: 3 years

  3. Geographic location of patients

    Time frame: 3 years

  4. Number of patients with previous treatments for gouty arthritis

    Time frame: 3 years

  5. Medical history of patients

    Time frame: 3 years

  6. Number of patients with comorbidities

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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