Skin Adverse Reactions Occuring in Children Treated by Biotherapy for Chronic Inflammatory Disease

Completed

• Conditions: Biotherapy; Allergic Skin Reaction; Ophthalmology; Dermatologic Complication; Chronic Inflammatory Disease; Rheumatology; Pediatric Disorder; Gastrointestinal Disease

• Registration Number: NCT04327752
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-12
• Study First Submitted: 2020-03-27
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-31
• Primary Completion: 2020-07-01
• Study Completion: 2020-10-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of the incidence of cutaneous adverse events under biological therapy	up to 8 months	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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France