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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05964946
Collaborator
(none)
15
1
25.1
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    15 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France
    Actual Study Start Date :
    Jun 24, 2020
    Actual Primary Completion Date :
    Jul 29, 2022
    Actual Study Completion Date :
    Jul 29, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients treated with canakinumab in France for the treatment of gouty arthritis [2 years]

    Secondary Outcome Measures

    1. Mean age of patients [3 years]

    2. Number of male patients [3 years]

    3. Geographic location of patients [3 years]

    4. Number of patients with previous treatments for gouty arthritis [3 years]

    5. Medical history of patients [3 years]

    6. Number of patients with comorbidities [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Paris France 92506

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05964946
    Other Study ID Numbers:
    • CACZ885HFR01
    First Posted:
    Jul 28, 2023
    Last Update Posted:
    Jul 28, 2023
    Last Verified:
    Jul 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2023