Clinical trial NCT03480529: Monitoring the IMmUological TOXicity of Drugs
Official title: Monitoring the IMmUological TOXicity of Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Capillary Leak Syndrome
Hepatitis
Keywords: adverse event
arthritis
Systemic Lupus Erythematosus
Capillary Leak Syndrome
Hepatitis
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2018-03-29
Enrollment: 662
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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:
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Secondary outcomes:
measure: Causality assessment of reported arthritis, hepatitis, or lupus events according to the WHO system
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
measure: Description of the type of arthritis or lupus or hepatitis or capillary leak syndrom depending on the category of drug
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
measure: Description of the other immune related adverse events concomitant to the arthritis or lupus or hepatitis or capillary leak syndrom induced by drugs
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
measure: Description of the duration of treatment when the toxicity happens (role of cumulative dose)
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
measure: Description of the drug-drug interactions associated with adverse events
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
measure: Description of the population of patients having a arthritis or lupus or hepatitis or CLS adverse event
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
city: Strasbourg
country: France
facility: Rhumatology department, CHU Strasbourg, Hautepierre hospital
Study officials:
References:
citation: Arnaud L, Lebrun-Vignes B, Salem JE. Checkpoint inhibitor-associated immune arthritis. Ann Rheum Dis. 2019 Jul;78(7):e68. doi: 10.1136/annrheumdis-2018-213470. Epub 2018 May 3. No abstract available.
citation: Mertz P, Lebrun-Vignes B, Salem JE, Arnaud L. Characterizing drug-induced capillary leak syndromes using the World Health Organization VigiBase. J Allergy Clin Immunol. 2019 Jan;143(1):433-436. doi: 10.1016/j.jaci.2018.09.001. Epub 2018 Sep 20. No abstract available.
citation: Arnaud L, Mertz P, Gavand PE, Martin T, Chasset F, Tebacher-Alt M, Lambert A, Muller C, Sibilia J, Lebrun-Vignes B, Salem JE. Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database. Ann Rheum Dis. 2019 Apr;78(4):504-508. doi: 10.1136/annrheumdis-2018-214598. Epub 2019 Feb 4.