NMF-CsA-Dupi Trial
2021년 8월 17일 업데이트: Suzanne G.M.A. Pasmans, Erasmus Medical Center
Use of the NMF Biomarker as Predictive Diagnostic for Effective Use of Cyclosporine and Dupilumab in the Treatment of Atopic Dermatitis
The goal of this study is to investigate whether stratification of children with atopic dermatitis on the NMF biomarkers results in an improvement of effectiveness and efficiency in the use of systemic treatment (ciclosporin and dupilumab) in moderate-to-severe atopic dermatitis.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (예상)
318
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Suzanne G.M.A. Pasmans, Prof
- 전화번호: +31 6 53524299
- 이메일: s.pasmans@erasmusmc.nl
연구 장소
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Zuid-Holland
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Rotterdam, Zuid-Holland, 네덜란드
- 모병
- Erasmus MC - Sophia Children's Hospital
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연락하다:
- prof. S.G.M.A. Pasmans, MD PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
2년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Children and adolescents, aged 2-18 years, with moderate-to-severe atopic dermatitis (diagnosed according to the UK working party criteria)
- Patient and parents/guardians able to participate in the study and willing to give written informed consent
- EASI (Eczema Area Severity Index) ≥ 6 at screening and baseline (corresponding with moderate-to-severe disease)
- IGA (Investigator Global Assessment) ≥ 3 at screening and baseline (corresponding with moderate-to-severe disease)
Exclusion Criteria:
- Children under the age of 2 years and patients older than 18 years
- Contraindication for ciclosporin
- Contraindication for dupilumab
- Patient (or one of the parents/guardians) not willing to be randomized
- Children with a history of any known primary immunodeficiency disorder
- Children with a history of cancer
- EASI < 6 at screening or baseline
- IGA < 3 at screening or baseline
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Topical corticosteroids (control)
This group will receive topical corticosteroids.
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Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis.
In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed.
Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.
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활성 비교기: Systemic cyclosporine
This group will receive topical corticosteroids and systemic cyclosporin.
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Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis.
In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed.
Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.
Systemic cyclosporine A (CsA) is an immunosuppressive therapy and is a registered treatment for AD in adults. According to national guidelines, CsA is the first choice for systemic treatment in children with moderate-to-severe AD. For CsA a starting dose of 4-5mg/kg/day is administered orally and then tapered down to 2-3mg/kg/day depending on clinical effect. Two doses will be taken at two fixed times per day. Treatment with systemic CsA will be continued for a total of 6 months.
다른 이름들:
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활성 비교기: Systemic dupilumab
his group will receive topical corticosteroids and systemic dupilumab.
|
Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis.
In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed.
Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.
Dupilumab (DUPIXENT) is indicated for the treatment of children of 6 years and older with moderate-to-sever atopic dermatitis whos disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
DUPIXENT can be used with or without topical corticosteroids.
rm: Active Comparator: Systemic dupilumab Dupilumab (DUPIXENT) is administered as a solution by subdermal injection according to national guidelines, based on age and body weight.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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EASI
기간: t = 0, 1 month, 2 months, 3 months and 6 months
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Change from baseline Eczema Area and Severity Index (0-72) over the course of 6 months, with higher scores meaning worse outcomes.
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t = 0, 1 month, 2 months, 3 months and 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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EASI75
기간: t = 1 month, 2 months, 3 months and 6 months
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Relative reduction of 75% from baseline EASI without the use of rescue medication
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t = 1 month, 2 months, 3 months and 6 months
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IGA 0 or IGA 1
기간: t = 0, 1 month, 2 months, 3 months and 6 months
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Proportion of patients that achieved IGA 0 or IGA 1 (Investigator's Global Assessment) without the use of rescue medication.
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t = 0, 1 month, 2 months, 3 months and 6 months
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NRS-11 reduction for itch ≥ 4 points
기간: t = 0, 1 month, 2 months, 3 months and 6 months
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Proportion of patients that achieved a reduction ≥4 points on the Numeric Rating Scale-11 (0-10) for itch intensity.
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t = 0, 1 month, 2 months, 3 months and 6 months
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POEM
기간: t = 0, 1 month, 2 months, 3 months and 6 months
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Change from baseline in Patient-Oriented Eczema Measure questionnaire (0-28) over the course of 6 months, with higher scores meaning worse outcomes.
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t = 0, 1 month, 2 months, 3 months and 6 months
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SCORAD
기간: t = 0, 1 month, 2 months, 3 months and 6 months
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Change from baseline in Scoring Atopic Dermatitis scale (0-103) over the course of 6 months, with higher scores meaning worse outcomes.
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t = 0, 1 month, 2 months, 3 months and 6 months
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RECAP
기간: t = 0, 1 month, 2 months, 3 months and 6 months
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Change from baseline in the Recap of Atopic Eczema questionnaire (0-28) over the course of 6 months, with higher scores meaning worse outcomes.
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t = 0, 1 month, 2 months, 3 months and 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CDLQI ≥4 years
기간: t = 0, 3 months and 6 months
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Children's Dermatology Life Quality Index, in the context of a cost-effectiveness analysis
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t = 0, 3 months and 6 months
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IDQoL <4 years
기간: t = 0, 3 months and 6 months
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Infants' Dermatitis Quality of Life Index, in the context of a cost-effectiveness analysis
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t = 0, 3 months and 6 months
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Emollients and steroid use in frequency and tubes used
기간: t = 0, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
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In context of a cost-effectiveness analysis: To assess the use of topical medication, including emollients, expressed in number of grams and/or used tubes, and changes therein during systemic treatment.
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t = 0, 1 month, 2 months, 3 months, 4 months, 5 months and 6 months
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Healthcare costs related to the treatment of AD
기간: Over the course of 6 months
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In context of a cost-effectiveness analysis: To assess medical specialist care, hospitalization, medication, and other costs directly associated with the treatment and recurrence.
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Over the course of 6 months
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Adverse events
기간: Over the course of 6 months
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Adverse events related to therapy as reported at any time during treatment by patient, custodian or investigator.
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Over the course of 6 months
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NMF measured via Raman spectroscopy
기간: t = - 2 weeks, 0, 3 months and 6 months
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Natural Moisturizing Factor, to acquire more knowledge about external and internal factors that influence the NMF biomarker
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t = - 2 weeks, 0, 3 months and 6 months
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Microbiome profile
기간: t = 0, 3 months and 6 months
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To investigate differences in microbiome profiles between patients with normal vs low NMF, and to investigate changes from baseline in microbiome profile during treatment, periodic swabs of nose, lesional skin, non-lesional skin and faeces will be obtained from patients.
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t = 0, 3 months and 6 months
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Humoral blood panel (systemic arms)
기간: t = 0, 1 month, 3 months and 6 months
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Changes in IgE during systemic treatment over the course of 6 months.
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t = 0, 1 month, 3 months and 6 months
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Humoral blood panel (topical arm)
기간: t = 0 and 6 months
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Changes in IgE during topical treatment over the course of 6 months.
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t = 0 and 6 months
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Cellular blood panel (systemic arm)
기간: t = 0, 1 month, 3 months and 6 months
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Changes in leucocyte differentiation during systemic treatment over the course of 6 months.
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t = 0, 1 month, 3 months and 6 months
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FLG null mutations
기간: t = 0
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Genotyping on skin barrier proteins, to acquire more knowledge about external and internal factors that influence atopic dermatitis and the NMF biomarker
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t = 0
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Activity of atopy
기간: t = 0, 3 months and 6 months
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The activity of rhinoconjunctivitis, asthma and food allergy examined by a pediatric allergist and pediatric pulmonologist.
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t = 0, 3 months and 6 months
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Psychosocial factors (CBCL)
기간: t = 0
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To investigate the influence of psychosocial factors in the patient on pediatric atopic dermatitis as assessed by the CBCL (Child Behaviour Checklist).
Patients are assessed by questions grouped in empirically based syndrome scales: Aggressive Behavior, Anxious/Depressed, Attention Problems, Rule-Breaking Behavior, Somatic Complaints, Social Problems, Thought Problems, Withdrawn/Depressed. Higher percentile scores per scale indicate worse outcomes.
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t = 0
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Psychosocial factors (OBVL)
기간: t = 0
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To investigate the influence of psychosocial factors in the family on pediatric atopic dermatitis as assessed by the OBVL (OpvoedingsBelastingVragenLijst / Parenting Stress Questionnaire), with higher percentile scores indicating worse outcomes
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t = 0
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 8월 16일
기본 완료 (예상)
2024년 1월 1일
연구 완료 (예상)
2025년 1월 1일
연구 등록 날짜
최초 제출
2021년 4월 29일
QC 기준을 충족하는 최초 제출
2021년 5월 6일
처음 게시됨 (실제)
2021년 5월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 8월 17일
마지막으로 확인됨
2021년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MEC-2019-0568
- 2019-003247-30 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Topical corticosteroids에 대한 임상 시험
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