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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04327752
Other study ID # PI2018_843_0048
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2020
Est. completion date October 1, 2020

Study information

Verified date July 2021
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Biological treatments (BT) are commonly prescribed to treat chronic inflammatory diseases in children. Paradoxical reactions during treatment with a biological agent can be defined as the appearance or exacerbation of a pathological condition that usually responds to this class of drug while treating a patient for another condition. Limited data are available in children treated by BT on cutaneous paradoxical reactions, or any other cutaneous adverse events occurring during treatment. On the contrary, dermatologists tend to see and manage increasing numbers of cutaneous adverse events, including paradoxical reactions. The aim of this project is to describe the incidence of cutaneous adverse events, including cutaneous paradoxical reactions, occurring in the pediatric population, during a treatment by BT given for a chronic inflammatory disease.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Children under 18 years old - Children treated by biotherapy among : Adalimumab, Golimumab, Infliximab, Ustekinumab, Etanercept, Tocilizumab, Canakinumab, Anakinra, Abatacept. - Children treated for a chronic inflammatory disease (rheumatologic, gastro-enterologic, dermatologic and ophthalmologic) - Children treated in the CHU of Amiens - Parental consent signed Exclusion Criteria: - Age > 18 ans

Study Design


Intervention

Other:
dermatological consultation
Dermatological consultation will be done on every children treated by biotherapy for chronic inflammatory disease in the Amiens hospital.

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation of the incidence of cutaneous adverse events under biological therapy Determine the variation of the incidence of any skin manifestation under biological therapy, including Paradoxical Reaction (psoriasis, eczema, hidradenitis suppurativa …), non-paradoxical inflammatory reaction, infection, neoplasia, hair and nail manifestation, xerosis. up to 8 months
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