Monitoring Drug-induced Uveitis

Uveitis Clinical Trial

— UVETOX  

Official title:

Monitoring Drug-induced Uveitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03899922
• Other study ID #: CIC1421-19-07
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: April 4, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 4, 2023
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Uvea--Diseases
• Uveitis
• Uveitis Drug-Induced

Intervention

Drug:
• Drugs inducing uveitis
Drugs susceptible to induce uveitis

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/04/2019
Secondary	Causality assessment of reported uveitis according to the WHO system	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/04/2019
Secondary	All relevants statisticals associations between type of uveitis and the category of drug	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/04/2019
Secondary	All relevants statisticals associations between other concomittants immune related adverse events and uveitis induced by drugs	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/04/2019
Secondary	Duration of treatment when uveitis happen (role of cumulative dose)	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/04/2019
Secondary	All relevants statisticals associations between drug-drug interactions and adverse events	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/04/2019
Secondary	All relevants statisticals associations between pathologies (cancer) for which the incriminated drugs have been prescribed, and occurence of uveitis	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/04/2019
Secondary	All relevants statisticals associations between characteristics of the population and occurence of uveitis adverse event	Case reported in the World Health Organization (WHO) database of individual safety case reports	to 01/04/2019