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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT04327752

Collaborator

(none)

Enrollment

Location

6.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biotherapy Chronic Inflammatory Disease Allergic Skin Reaction Pediatric Disorder Dermatologic Complication Gastrointestinal Disease Ophthalmology Rheumatology	Other: dermatological consultation

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Cutaneous Adverse Effects Occurring in Children Under Biological Therapy Given for Chronic Inflammatory Diseases

Actual Study Start Date :

Mar 12, 2020

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Oct 1, 2020

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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