Clinical trial NCT05964946: Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France
Official title: Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gouty Arthritis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-07-28
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients treated with canakinumab in France for the treatment of gouty arthritis
timeFrame: 2 years
Secondary outcomes:
measure: Mean age of patients
timeFrame: 3 years
measure: Number of male patients
timeFrame: 3 years
measure: Geographic location of patients
timeFrame: 3 years
measure: Number of patients with previous treatments for gouty arthritis
timeFrame: 3 years
measure: Medical history of patients
timeFrame: 3 years
measure: Number of patients with comorbidities
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: