Monitoring the IMmUological TOXicity of Drugs

Rheumatoid Arthritis Clinical Trial

— MIMUTOX  

Official title:

Monitoring the IMmUological TOXicity of Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480529
• Other study ID #: CIC1421-18-05
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 10, 2018

Study information

• Verified date: September 2019
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: March 10, 2018
• Est. primary completion date: March 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom
Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.	Paris
France	Rhumatology department, CHU Strasbourg, Hautepierre hospital	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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 R — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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