NCT03994302

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2.1 years

First QC Date

June 19, 2019

Last Update Submit

April 12, 2023

Conditions

Antiphospholipid SyndromeImmune DiseaseAdverse Drug EventDrug Toxicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

Drug inducing antiphospholipid syndromeDRUG

Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome

Immune toxicity induced by drugs and chemotherapies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

You may qualify if:

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

You may not qualify if:

  • Chronology not compatible between the drug and the toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75013, France

Location

Related Publications (1)

  • 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.

    PMID: 35114404DERIVED

MeSH Terms

Conditions

Antiphospholipid SyndromeImmune System DiseasesDrug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Autoimmune DiseasesChemically-Induced Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant director, clinical investigation center Paris Est

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 21, 2019

Study Start

June 1, 2019

Primary Completion

June 30, 2021

Study Completion

April 8, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

FR(1)