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

NCT04327752 | Completed

• 1 other identifier: PI2018_843_0048
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Variation of the incidence of cutaneous adverse events under biological therapy

  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.

  up to 8 months

Interventions

dermatological consultation OTHER

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Age \> 18 ans

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: March 12, 2020
• Primary Completion: July 1, 2020
• Study Completion: October 1, 2020
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)