Monitoring the IMmUological TOXicity of Drugs

Completed

• Conditions: Rheumatoid Arthritis; Arthritis; Capillary Leak Syndrome; Systemic Lupus Erythematosus; Hepatitis
• Interventions: Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom

• Registration Number: NCT03480529
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief Summary

Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Detailed Description

Several drugs and chemotherapies seem to have an impact on the immunological system and are responsible of a wide range of rare immunological side effects. 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 rare immunological side effects (of which systemic lupus, immune arthritis, rheumatoid arthritis, Hepatitis, capillary leak syndrome) imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-03-10
• Study Completion: 2018-03-10
• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-03-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 662

Inclusion Criteria

• Case reported in the WHO's pharmacovigilance database till 02/01/2018
• Adverse event reported were including the MedDRA terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome.

Exclusion Criteria

• Chronology not compatible between the drug and the toxicity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arthritis or lupus or CLS induced by a drug	drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom	Case reported in the World Health Organization (WHO) of arthritis or lupus, or Hepatitis, or capillary leak syndrome of patient treated by a drug, with a chronology compatible with the drug toxicity

Primary Outcome Measures

Name	Time	Method
Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms:	Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

Secondary Outcome Measures

Name	Time	Method
Causality assessment of reported arthritis, hepatitis, or lupus events according to the WHO system	Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the type of arthritis or lupus or hepatitis or capillary leak syndrom depending on the category of drug	Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the other immune related adverse events concomitant to the arthritis or lupus or hepatitis or capillary leak syndrom induced by drugs	Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
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 to 02/01/2018
Description of the drug-drug interactions associated with adverse events	Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
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 to 02/01/2018
Description of the population of patients having a arthritis or lupus or hepatitis or CLS adverse event	Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

Trial Locations

Locations (2)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.; 🇫🇷 Paris, France

Rhumatology department, CHU Strasbourg, Hautepierre hospital; 🇫🇷 Strasbourg, France