Trials / Completed
CompletedNCT03492242
Immune CHeckpoint Inhibitors Monitoring of Adverse Drug ReAction
Monitoring of Immune Checkpoint Inhibitors Adverse Drug Reactions Through the WHO Vigilyze and French Pharmaco-vigilance Database (Base Nationale de Pharmacovigilance BNPV)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (actual)
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin. This study investigates reports of drug induced irAEs with treatment including anti-PD1, Anti-PDL-1, and Anti-CTLA4 classes using the World Health Organization (WHO) database VigiBase and the french database Base Nationale de PharmacoVigilance (BNPV).
Detailed description
Immune checkpoint inhibitors (ICIs) have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, immune-related adverse events (irAEs) can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, and in the Base Nationale de PharmacoVigilance (BNPV) which is the french pharmacovigilance database, to identify cases of adverse drug reaction including arthiritis, auto-immune induced diseases, cardiac diseases, endocrinologic diseases, following treatment with ICIs.
Conditions
- Arthritis
- Cancer
- Cardiac Disease
- Endocrine System Diseases
- Autoimmune Diseases
- Ophthalmopathy
- Myositis
- Neuropathy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Immune checkpoint inhibitor | Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification) as a monotherapy or in combination: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32). |
Timeline
- Start date
- 2018-02-01
- Primary completion
- 2018-09-30
- Completion
- 2018-09-30
- First posted
- 2018-04-10
- Last updated
- 2019-09-26
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03492242. Inclusion in this directory is not an endorsement.