- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04327752
Skin Adverse Reactions Occuring in Children Treated by Biotherapy for Chronic Inflammatory Disease (MDEBMIC)
July 20, 2021 updated by: Centre Hospitalier Universitaire, Amiens
Cutaneous Adverse Effects Occurring in Children Under Biological Therapy Given for Chronic Inflammatory Diseases
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80480
- CHU Amiens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of the incidence of cutaneous adverse events under biological therapy
Time Frame: up to 8 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2020
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
October 1, 2020
Study Registration Dates
First Submitted
March 27, 2020
First Submitted That Met QC Criteria
March 27, 2020
First Posted (Actual)
March 31, 2020
Study Record Updates
Last Update Posted (Actual)
July 21, 2021
Last Update Submitted That Met QC Criteria
July 20, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2018_843_0048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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