Clinical trial NCT04327752: Skin Adverse Reactions Occuring in Children Treated by Biotherapy for Chronic Inflammatory Disease
Official title: Cutaneous Adverse Effects Occurring in Children Under Biological Therapy Given for Chronic Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biotherapy
Chronic Inflammatory Disease
Allergic Skin Reaction
Pediatric Disorder
Dermatologic Complication
Gastrointestinal Disease
Ophthalmology
Rheumatology
Keywords: Biotherapy
Chronic Inflammatory Disease
skin adverse event
paradoxical reaction
cutaneous manifestation
pediatry
dermatology
gastro-enterology
ophthalmology
rheumatology
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * For the children already under biological therapy for an inflammatory chronic disease : they will benefit of one dermatologic consultation at any time of their treatment. Other consultations can be asked by the patient or by his parents if any skin manifestation appears beside the planned date of the consultation.
* For the children who are going to be treated by a biological therapy : they will benefit of one dermatologic consultation BEFORE the onset of the biological therapy, and on other one at 4 months afetr the beginning of the treatment. Other consultations can be asked by the patient or his parents if any skin manifestation appears beside the planned dates of both consultations.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Variation of the incidence of cutaneous adverse events under biological therapy
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: