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Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)

NCT ID: NCT03994302

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-04-08

Brief Summary

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Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

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Detailed Description

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Several drugs and chemotherapies seem to have an impact on the immune system and are responsible of a wide range of immune side effects such as antiphospholipid syndrome. Those are poorly described, due to the modificationof the pharmacopeia, and the recent recognition of several of these adverseevents.

This study investigates the main characteristics of patients affected by immune side effects imputed to drugs in particular antiphospholipid syndrome.

A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Conditions

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Antiphospholipid Syndrome Immune Disease Adverse Drug Event Drug Toxicity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Immune toxicity induced by drugs and chemotherapies

Immune toxicity induced by drugs and chemotherapies Case reported in the World Health Organization (WHO) of immune toxicities(such as Antiphospholipid syndrome) of patient treated by a drug, with a chronology compatible with the drug toxicity

Drug inducing antiphospholipid syndrome

Intervention Type DRUG

Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome

Interventions

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Drug inducing antiphospholipid syndrome

Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Case reported in the WHO's pharmacovigilance database till 01/06/2019

Exclusion Criteria

* Chronology not compatible between the drug and the toxicity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Joe Elie Salem

Assistant director, clinical investigation center Paris Est

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, , France

Site Status

Countries

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France

References

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Gerardin C, Bihan K, Salem JE, Khachatryan H, Gerotziafas G, Fain O, Mekinian A. Drug-induced antiphospholipid syndrome: Analysis of the WHO international database. Autoimmun Rev. 2022 May;21(5):103060. doi: 10.1016/j.autrev.2022.103060. Epub 2022 Feb 1.

Reference Type DERIVED
PMID: 35114404 (View on PubMed)

Other Identifiers

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CIC1421-19-10

Identifier Type: -

Identifier Source: org_study_id

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