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Идёт набор NCT06382987

A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect)

— Наблюдательное Plaque Psoriasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Deucravacitinib, Apremilast.
Кому может быть актуально
Состояния в реестре: Plaque Psoriasis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Registry of Psoriasis Health Outcomes: A Longitudinal Real-world Collaboration (RePhlect) - A Real-World, Prospective, Observational Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan

Обзор

This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast.

Вмешательства

  • Препарат Deucravacitinib
    According to the product label
  • Препарат Apremilast
    According to the product label

Первичные конечные точки

  • Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
Вторичные конечные точки (12)
  • Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]
  • Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up [Срок оценки: 1 month, 3 months, 6 months and every 6 months up to 5 years]

Критерии участия

Критерии включения

  • Japanese adult participants aged 18 years old or older
  • Physician-reported diagnosis of plaque psoriasis
  • Newly initiating deucravacitinib or apremilast according to the label
  • Participants who have signed informed consent

Критерии исключения

  • Participants currently participating in or planning to participate in an interventional clinical trial
  • Patients enrolled in deucravacitinib post-marketing surveillance study (ClinicalTrial.gov ID: NCT05633264)
  • Previous treatment experience with the treatment of interest (e.g. patients who have history of apremilast will not be eligible to be enrolled in apremilast arm of the study and similar for deucravacitinib)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Япония · 2 центра
  • Mebix. Inc. — Minato-ku
  • Fukuoka University Hospital — Fukuoka

Идентификаторы

NCT: NCT06382987 · IM011-1124

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗