Monitoring Drug-induced Uveitis

Completed

• Conditions: Uveitis; Uvea--Diseases; Uveitis Drug-Induced; Eye Diseases
• Interventions: Drug: Drugs inducing uveitis

• Registration Number: NCT03899922
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

Several drugs and chemotherapies seem to induce uveitis. This study investigates reports of uveitis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Detailed Description

Several drugs and chemotherapies seem to have an impact on the eyes and are responsible of uveitis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by uveitis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Primary Completion: 2020-04-01
• Status Verified: 2023-04
• Study Completion: 2023-04-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Case reported in the WHO's pharmacovigilance database till 01/04/2019

Exclusion Criteria

• Chronology not compatible between the drug and the toxicity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Uveitis induced by drugs and chemotherapies	Drugs inducing uveitis	Case reported in the World Health Organization (WHO) of uveitis of patient treated by a drug, with a chronology compatible with the drug toxicity

Primary Outcome Measures

Name	Time	Method
Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs	to 01/04/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports

Secondary Outcome Measures

Name	Time	Method
Causality assessment of reported uveitis according to the WHO system	to 01/04/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
Duration of treatment when uveitis happen (role of cumulative dose)	to 01/04/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between type of uveitis and the category of drug	to 01/04/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between other concomittants immune related adverse events and uveitis induced by drugs	to 01/04/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between drug-drug interactions and adverse events	to 01/04/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between pathologies (cancer) for which the incriminated drugs have been prescribed, and occurence of uveitis	to 01/04/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports
All relevants statisticals associations between characteristics of the population and occurence of uveitis adverse event	to 01/04/2019	Case reported in the World Health Organization (WHO) database of individual safety case reports

Trial Locations

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM; 🇫🇷 Paris, France