Monitoring the IMmUological TOXicity of Drugs (MIMUTOX)

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Capillary Leak Syndrome; Hepatitis; Arthritis; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom

Study type: Observational

Funder types: Other

Identifiers

NCT03480529

CIC1421-18-05

Details and patient eligibility

About

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).

Full 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.

Enrollment: 662 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

662 participants in 1 patient group

Arthritis or lupus or CLS induced by a drug

Description:

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

Treatment:

Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom