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

Gouty Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05964946
• Other study ID #: CACZ885HFR01
• Status: Completed
• Start date: June 24, 2020
• Est. completion date: July 29, 2022

Study information

• Verified date: July 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 29, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty
• Gouty Arthritis

Locations

Country	Name	City	State
France	Novartis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients treated with canakinumab in France for the treatment of gouty arthritis		2 years
Secondary	Mean age of patients		3 years
Secondary	Number of male patients		3 years
Secondary	Geographic location of patients		3 years
Secondary	Number of patients with previous treatments for gouty arthritis		3 years
Secondary	Medical history of patients		3 years
Secondary	Number of patients with comorbidities		3 years