Status:
COMPLETED
Monitoring the IMmUological TOXicity of Drugs
Lead Sponsor:
Groupe Hospitalier Pitie-Salpetriere
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Arthritis
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
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 ...
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 modif...
Eligibility Criteria
Inclusion
- 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
- Chronology not compatible between the drug and the toxicity
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 10 2018
Estimated Enrollment :
662 Patients enrolled
Trial Details
Trial ID
NCT03480529
Start Date
March 1 2018
End Date
March 10 2018
Last Update
September 4 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
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