Secukinumab 치료를 시작한 화농한선염 환자의 단기 치료 만족도 및 삶의 질 평가.
아랍에미리트에서 일상적인 임상 실습에서 Secukinumab으로 시작한 화농한선염 환자의 단기 치료 만족도 및 삶의 질 평가: ILLUMINATE-HS, 전향적 생존 환자
This study will be conducted to address the lack of concrete data on the impact of pharmaceutical intervention on short-term patient satisfaction and quality of life (QoL) in patients with Hidradenitis Suppurativa (HS) in real-world settings, especially in the Gulf Region.
연구 개요
상세 설명
This is a 24-week longitudinal single-arm prospective study based on data collected from EMRs along with patient-reported outcomes questionnaires (TSQM and DLQI) to evaluate patient-reported satisfaction and early quality of life experiences among HS patients who are newly initiated on Secukinumab. We will be using questionnaires at baseline and at week 24 to report on pre-defined outcomes in a representative HS population across the United Arab Emirates. The data will be collected using an electronic Case Report Form (eCRF) from both data sources (Electronic Medical Report and Questionnaires).
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Abu Dhabi, 아랍 에미리트
- Novartis Investigative Site
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Al Ain Abu Dhabi, 아랍 에미리트
- Novartis Investigative Site
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Ras al-Khaimah, 아랍 에미리트
- Novartis Investigative Site
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Sharjah city, 아랍 에미리트
- Novartis Investigative Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
설명
Inclusion Criteria:
- Patient with a confirmed diagnosis of active moderate to severe HS (Hurley Score 2-3)
- Male or Female adult patients ≥ 18 years of age at the time of data collection
- Patient newly initiated on Secukinumab (first dose to coincide within 1 month of the signature of the informed consent)
- Patients with a diagnosis of HS who are currently using antibiotics/ have undergone surgery or not as part of their routine clinical management are eligible for inclusion.
- Patients with a diagnosis of HS who have a history of previous treatment with Adalimumab or any other anti-TNF agent as part of their routine clinical management or biologic naïve are eligible for inclusion.
- Agreed to sign an informed consent to be able to fill in the questionnaires.
Exclusion Criteria:
- Patients not fulfilling any of the abovementioned inclusion criteria.
- Patient's refusal to be included in the study or refusal to sign the informed consent.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Secukinumab
Patients who are newly initiated on treatment with Secukinumab |
This is an observational study. There is no treatment allocation. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
기간: At Week 24
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TSQM scoring is calculated by domain, and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher patient satisfaction. 4 Domains: Effectiveness Side Effects Convenience Global Satisfaction |
At Week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
기간: Baseline, Week 24
|
DLQI is a questionnaire designed to measure the impact of skin conditions on a patient's health-related quality of life. It contains 10 simple, self-administered questions. Focuses on the past week's experiences related to the skin condition. Each question uses a 4-point Likert scale: "Not at all," "A little," "A lot," "Very much." |
Baseline, Week 24
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Change from baseline in the Numerical Rating Scale (NRS)
기간: Baseline, Week 24
|
The NRS is commonly used for measuring pain intensity and is well validated. It is scored from 0-10 (0 meaning no pain and 10 meaning the worst pain imaginable). |
Baseline, Week 24
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Age (years)
기간: Baseline
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Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
Baseline
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Gender (male/female)
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Ethnicity
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Weight (kilogram)
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Height (meters)
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Socio-economic status
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Smoking status
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Duration of the disease (time since diagnosis)
기간: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
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Previous HS-related treatment
기간: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
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Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Hurley Stage
기간: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
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Number of inflammatory nodules, number of abscesses, and fistulas
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Previous HS-related surgeries
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Previous use of biologic treatment
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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Previous and current use of antibiotics treatment
기간: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CAIN457AAE02
약물 및 장치 정보, 연구 문서
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