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

NCT04327752 — Completed, 20 participants, Centre Hospitalier Universitaire, Amiens

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

Registry	NCT04327752, acronym MDEBMIC
Status	Completed
Study type	Observational
Enrollment	20 (Actual)
Sponsor	Centre Hospitalier Universitaire, Amiens (Other)
Conditions	Biotherapy, Chronic Inflammatory Disease, Allergic Skin Reaction, Pediatric Disorder, Dermatologic Complication, Gastrointestinal Disease, Ophthalmology, Rheumatology
Interventions	dermatological consultation (Other)
Dates	start 2020-03-12, primary completion 2020-07-01, completion 2020-10-01, first posted 2020-03-31, last updated 2021-07-21
Locations	1 site in France

-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.

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+Arms and interventions

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

+Outcome measures

Primary outcomes

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

Sex: All, ages: any to 18 Years

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

+Locations (1)

Facility	City	Country	Status
CHU Amiens	Amiens	France

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