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Идёт набор NCT04465838

Chinese Psoriasis Real World Evidence Research

— Наблюдательное 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: NIS.
Кому может быть актуально
Состояния в реестре: Psoriasis. Базовые параметры: Без ограничений · 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
Китай
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

A Real World Evidence Study in Chinese Psoriasis Patients

Обзор

This research is a multicenter,observational study under real world settings in patients diagnosed as psoriasis by dermatologist in the clinic. As patient's choice of medication should be fully respected, all the patients can choose the treatments they prefer, like phototherapy, traditional systemic therapy or biologics. And the study was conducted to compare the effectiveness among different choices of medication in Chinese psoriasis patients.

Подробное описание

Psoriasis is a chronic, recurrent inflammatory disease which is caused by heredity, environment and other factors. The typical clinical manifestation are erythematosquamous lesions, and the disease can progress to involve several organs. In view of its complex pathogenesis, there exists various of treatment of psoriasis like traditional systemic drugs and biologics.

This study is an observational, multi-centre study based on real-world evidence. Inclusion criteria is the patients who visit the clinic diagnosed psoriasis by the dermatologist. There existed no exclusion criteria. Information were most collected by a phone application called "Psoriasis New World".

Primary outcome measure is the percentage of patients who achieved a PASI reduction of 100% (PASI 100). And Psoriasis Area and Severity Index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher PASI scores indicating worse condition. Also, static Physician Global Assessment (sPGA), static Investigator Global Assessment (sIGA), Body surface area (BSA) and Dermatology Life Quality Index (DLQI) are measured to assess the severity of psoriasis and the change of the disease condition. It is important to monitor all the Adverse Events (AEs) over the whole study. In addition, the laboratory examinations of patients such as liver function are also collected.

Вмешательства

  • Другое NIS
    This is a non-interventional study (NIS).

Первичные конечные точки

  • The percentage of patients who achieved a PASI reduction of 100% (PASI 100) [Срок оценки: 6 months]
Вторичные конечные точки (9)
  • The percentage of patients who achieved a PASI reduction of 100% (PASI 100) [Срок оценки: 6 months and 12 months]
  • The percentage of patients who achieved a PASI reduction of 75% (PASI 75) [Срок оценки: 6 months and 12 months]
  • The percentage of patients who achieved a PASI reduction of 50% (PASI 50) [Срок оценки: 6 months and 12 months]
  • static Physician Global Assessment (sPGA) = 0 [Срок оценки: 6 months and 12 months]
  • static Investigator Global Assessment (sIGA) = 0 [Срок оценки: 6 months and 12 months]
  • Body surface area (BSA) [Срок оценки: 6 months and 12 months]
  • Dermatology Life Quality Index (DLQI) =0 [Срок оценки: 6 months and 12 months]
  • Adverse Events (AEs) [Срок оценки: Up to 12 months]
  • Visual Analog Scale (VAS) [Срок оценки: 6 months and 12 months]

Критерии участия

Критерии включения

  • all the patients diagnosed as psoriasis by dermatologist in clinic.

Критерии исключения

  • None

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 29 центров
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу
  • Beijing Children's Hospital Affiliated to Capital Medical University — Пекин
  • the First Affiliated Hospital of Chongqing Medical University — Чунцин
  • the First Affiliated Hospital of Fujian Medical University — Fujian
  • General Hospital of Lanzhou Military Region — Gansu
  • Sun Yat-sen Memorial Hospital — Guangdong
  • The Peoples' Hospital of Guangxi Zhuang Autonomous Region — Guangxi
  • the Affiliated Hospital of Guizhou Medical University — Guizhou
  • … и ещё 21 центр

Идентификаторы

NCT: NCT04465838 · 2020-354

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗