Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX) (APSTOX)

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).

Study Overview

• Status: Completed
• Conditions: Antiphospholipid Syndrome; Adverse Drug Event; Drug Toxicity; Immune Disease
• Intervention / Treatment: Drug: Drug inducing antiphospholipid syndrome

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 2700

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: Drug inducing antiphospholipid syndrome; Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.	Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019

Secondary Outcome Measures

Outcome Measure	Time Frame
Causality assessment of reported metabolic toxicities events according to the WHO system Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the type of immune toxicity depending on the category of drug Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the other immune related adverse events concomitant to the immune toxicity induced by drugs Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the duration of treatment when the toxicity happens (role of cumulative dose) Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the drug-drug interactions associated with adverse events Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019
Description of the population of patients having hematological toxicity adverse event Case reported in the World Health Organization (WHO) database of individual safety case reports	01/06/2019

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere

Publications and helpful links

General Publications

• Ferreira JP, Duarte-Mendes P, Teixeira AM, Silva FM. Effects of combined training on metabolic profile, lung function, stress and quality of life in sedentary adults: A study protocol for a randomized controlled trial. PLoS One. 2022 Feb 3;17(2):e0263455. doi: 10.1371/journal.pone.0263455. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): April 8, 2023

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Autoimmune Diseases; Disease; Syndrome; Drug-Related Side Effects and Adverse Reactions; Immune System Diseases; Antiphospholipid Syndrome
• Other Study ID Numbers: CIC1421-19-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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.: No