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

Gastrointestinal Disease Clinical Trial

— MDEBMIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327752
• Other study ID #: PI2018_843_0048
• Status: Completed
• Start date: March 12, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Skin Reaction
• Biotherapy
• Chronic Inflammatory Disease
• Dermatologic Complication
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Ophthalmology
• Pediatric Disorder
• Rheumatology

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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