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

NCT ID: NCT04327752

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-12

Study Completion Date

2020-10-01

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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dermatological consultation

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

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

Other Identifiers

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PI2018_843_0048

Identifier Type: -

Identifier Source: org_study_id

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