MIMUTOX: Monitoring the IMmUological TOXicity of Drugs

Sponsor

Groupe Hospitalier Pitie-Salpetriere (Other)

Overall Status

Completed

CT.gov ID

NCT03480529

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

662

Enrollment

Locations

Actual Duration (Days)

331

Patients Per Site

1119.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Arthritis Systemic Lupus Erythematosus Rheumatoid Arthritis Capillary Leak Syndrome Hepatitis	Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

662 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Monitoring the IMmUological TOXicity of Drugs

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Mar 10, 2018

Actual Study Completion Date :

Mar 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Arthritis or lupus or CLS induced by a drug 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	Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom

Arm

Intervention/Treatment

Arthritis or lupus or CLS induced by a drug

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

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

Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.	Paris		France	75013
2	Rhumatology department, CHU Strasbourg, Hautepierre hospital	Strasbourg		France	67098