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Monitoring Drug-induced Uveitis (UVETOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03899922
Recruitment Status : Unknown
Verified September 2019 by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere.
Recruitment status was:  Recruiting
First Posted : April 2, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: to 01/04/2019 ]
    Case reported in the World Health Organization (WHO) database of individual safety case reports


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899922


Contacts
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Contact: Joe-Elie Salem, MD, PhD (0)1 42 17 85 35 ext +33 joe-elie.salem@aphp.fr

Locations
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France
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM Recruiting
Paris, France, 75013
Contact: Joe-Elie Salem, Md, PhD    (0)1 42 17 85 35 ext +33    joe-elie.salem@aphp.fr   
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
More Information
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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: April 2, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Groupe Hospitalier Pitie-Salpetriere:
Uvea toxicity
chemotherapies
drugs
Additional relevant MeSH terms:
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Eye Diseases
Uveitis
Uveal Diseases