NCT03480529

Monitoring the IMmUological TOXicity of Drugs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 662 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis
• Systemic Lupus Erythematosus
• Rheumatoid Arthritis
• Capillary Leak Syndrome
• Hepatitis

Interventions

Type	Name	Description
DRUG	drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom	Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-03-10
• Completion: 2018-03-10
• First posted: 2018-03-29
• Last updated: 2019-09-04

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated drug study