UVETOX: Monitoring Drug-induced Uveitis

• Sponsor: Groupe Hospitalier Pitie-Salpetriere (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03899922
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 83.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Uveitis; Uveitis Drug-Induced; Eye Diseases; Uvea--Diseases	Drug: Drugs inducing uveitis

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Monitoring Drug-induced Uveitis
• Actual Study Start Date: Apr 1, 2019
• Anticipated Primary Completion Date: Apr 1, 2020
• Anticipated Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Uveitis induced by drugs and chemotherapies Case reported in the World Health Organization (WHO) of uveitis of patient treated by a drug, with a chronology compatible with the drug toxicity	Drug: Drugs inducing uveitis; Drugs susceptible to induce uveitis

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris		France	75013

Sponsors and Collaborators

• Groupe Hospitalier Pitie-Salpetriere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere
• ClinicalTrials.gov Identifier: NCT03899922
• Other Study ID Numbers: CIC1421-19-07
• First Posted: Apr 2, 2019
• Last Update Posted: Sep 4, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere: Uvea toxicity; chemotherapies; drugs
• Additional relevant MeSH terms: Eye Diseases; Uveitis

Study Results

No Results Posted as of Sep 4, 2019