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Monitoring the IMmUological TOXicity of Drugs (MIMUTOX)

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ClinicalTrials.gov Identifier: NCT03480529
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

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
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 662 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Monitoring the IMmUological TOXicity of Drugs
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : March 10, 2018
Actual Study Completion Date : March 10, 2018


Group/Cohort 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with a drug that could be reported in the French WHO's pharmacovigilance database
Criteria

Inclusion Criteria:

  • Case reported in the French 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480529


Locations
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France
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, France, 75013
Rhumatology department, CHU Strasbourg, Hautepierre hospital
Strasbourg, France, 67098
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
Institut National de la Santé Et de la Recherche Médicale, France

Additional Information:

Publications of Results:
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Responsible Party: Joe Elie Salem, MD,PhD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03480529     History of Changes
Other Study ID Numbers: CIC1421-18-05
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
adverse event
arthritis
Systemic Lupus Erythematosus
Capillary Leak Syndrome
Hepatitis

Additional relevant MeSH terms:
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Hepatitis
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Capillary Leak Syndrome
Liver Diseases
Digestive System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases