セクキヌマブを開始した化膿性汗腺炎患者の短期治療満足度および生活の質の評価。
アラブ首長国連邦の日常臨床でセクキヌマブを開始した化膿性汗腺炎患者の短期治療満足度および生活の質の評価：前向き患者調査ILLUMINATE-HS
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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Abu Dhabi、アラブ首長国連邦
- Novartis Investigative Site
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Al Ain Abu Dhabi、アラブ首長国連邦
- Novartis Investigative Site
-
Ras al-Khaimah、アラブ首長国連邦
- Novartis Investigative Site
-
Sharjah city、アラブ首長国連邦
- Novartis Investigative Site
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Secukinumab
Patients who are newly initiated on treatment with Secukinumab |
This is an observational study. There is no treatment allocation. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
時間枠：At Week 24
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
時間枠：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
|
|
Change from baseline in the Numerical Rating Scale (NRS)
時間枠：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
|
|
Age (years)
時間枠：Baseline
|
Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
Baseline
|
|
Gender (male/female)
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Ethnicity
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Weight (kilogram)
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Height (meters)
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Socio-economic status
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Smoking status
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Duration of the disease (time since diagnosis)
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related treatment
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Hurley Stage
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Number of inflammatory nodules, number of abscesses, and fistulas
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related surgeries
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous use of biologic treatment
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous and current use of antibiotics treatment
時間枠：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CAIN457AAE02
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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