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NCT Number: NCT03480529

Monitoring the IMmUological TOXicity of Drugs

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).

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Key information

Conditions

Arthritis Arthritis, Rheumatoid Autoimmune Diseases Capillary Leak Syndrome Cardiovascular Diseases Connective Tissue Diseases Digestive System Diseases Hepatitis Immune System Diseases Joint Diseases Liver Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Systemic Lupus Erythematosus Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Primary outcomes

  1. 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:

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

Secondary outcomes

  1. Causality assessment of reported arthritis, hepatitis, or lupus events according to the WHO system

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

  2. Description of the type of arthritis or lupus or hepatitis or capillary leak syndrom depending on the category of drug

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

  3. Description of the other immune related adverse events concomitant to the arthritis or lupus or hepatitis or capillary leak syndrom induced by drugs

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

  4. Description of the duration of treatment when the toxicity happens (role of cumulative dose)

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

  5. Description of the drug-drug interactions associated with adverse events

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

  6. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

  7. Description of the population of patients having a arthritis or lupus or hepatitis or CLS adverse event

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: MIMUTOX

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2018
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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