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

C

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

Gastrointestinal Disease
Biotherapy
Pediatric Disorder
Rheumatology
Ophthalmology
Chronic Inflammatory Disease
Allergic Skin Reaction
Dermatologic Complication

Treatments

Other: dermatological consultation

Study type

Observational

Funder types

Other

Identifiers

NCT04327752
PI2018_843_0048

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

Under 18 years old

Volunteers

No 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

Exclusion criteria

  • Age > 18 ans

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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