Avaliação da satisfação e qualidade de vida do tratamento de curto prazo em pacientes com hidradenite supurativa iniciados com secucinumabe.
Avaliação da satisfação e qualidade de vida do tratamento de curto prazo em pacientes com hidradenite supurativa iniciados com secuquinumabe na prática clínica de rotina nos Emirados Árabes Unidos: ILLUMINATE-HS, uma pesquisa prospectiva de pacientes
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.
Visão geral do estudo
Descrição detalhada
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).
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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-
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Abu Dhabi, Emirados Árabes Unidos
- Novartis Investigative Site
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Al Ain Abu Dhabi, Emirados Árabes Unidos
- Novartis Investigative Site
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Ras al-Khaimah, Emirados Árabes Unidos
- Novartis Investigative Site
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Sharjah city, Emirados Árabes Unidos
- Novartis Investigative Site
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: OTHER
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Secukinumab
Patients who are newly initiated on treatment with Secukinumab |
This is an observational study. There is no treatment allocation. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
Prazo: 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)
Prazo: 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)
Prazo: Baseline
|
Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
Baseline
|
|
Gender (male/female)
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Ethnicity
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Weight (kilogram)
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Height (meters)
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Socio-economic status
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Smoking status
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Duration of the disease (time since diagnosis)
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related treatment
Prazo: 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
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Hurley Stage
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Number of inflammatory nodules, number of abscesses, and fistulas
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related surgeries
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous use of biologic treatment
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous and current use of antibiotics treatment
Prazo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CAIN457AAE02
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