BiotherapyMDEBMICNCT04327752
Skin Adverse Reactions Occuring in Children Treated by Biotherapy for Chronic Inflammatory Disease
An observational study of Biotherapy and Chronic Inflammatory Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Biotherapy, Chronic Inflammatory Disease, Allergic Skin Reaction
- What is being tested?
- dermatological consultation
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2020to 1 Oct 2020
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Age > 18 ans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Biotherapy, Chronic Inflammatory Disease, Allergic Skin Reaction, Pediatric Disorder, Dermatologic Complication, Gastrointestinal Disease
- Being tested
- dermatological consultation
- Keywords
- Biotherapy, Chronic Inflammatory Disease, skin adverse event, paradoxical reaction, cutaneous manifestation, pediatry, dermatology, gastro-enterology, ophthalmology, rheumatology
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dermatological consultationOther
Dermatological consultation will be done on every children treated by biotherapy for chronic inflammatory disease in the Amiens hospital.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start12 Mar 2020
- Primary completion1 Jul 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327752
- Sponsor's protocol ID
- PI2018_843_0048
- Acronym
- MDEBMIC
- Status last verified
- Jul 2021
- First submitted
- 27 Mar 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No