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Набор скоро начнётся NCT07642544

Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis

— Наблюдательное Psoriasis Psoriasis (PsO)

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: Standard Maintenance, Non-standard Maintenance.
Кому может быть актуально
Состояния в реестре: Psoriasis, Psoriasis (PsO). 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
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

Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis: A Single-Center Real-World Cross-Sectional Retrospective Study

Обзор

To evaluate the long-term efficacy of two maintenance treatment patterns of secukinumab-the standard maintenance group and the non-standard maintenance group-by assessing the median time to onset and incidence of secondary failure, as well as the time to regain response after dose escalation of secukinumab (including re-initiation of intensive dosing or shortening of the injection interval) in patients who experienced secondary failure.

Вмешательства

  • Препарат Standard Maintenance
    5-week standard induction period (Weeks 0, 1, 2, 3, 4) followed by 300 mg maintenance treatment with ≥90% of recorded injection intervals falling within every 4 weeks ± 7 days (21-35 days).
  • Препарат Non-standard Maintenance
    5-week standard induction period (Weeks 0, 1, 2, 3, 4) followed by at least 3 consecutive documented 300 mg maintenance injections with intervals all longer than 5 weeks (\>35 days); or followed by at least 3 consecutive documented 150 mg maintenance injections with intervals falling within every 4 weeks ± 7 days (21-35 days).

Первичные конечные точки

  • Time to onset of secondary failure [Срок оценки: 36 months]
Вторичные конечные точки (3)
  • Failure-free survival rate [Срок оценки: 12, 24, and 36 months]
  • Proportion of patients receiving different dose escalation strategies [Срок оценки: 12, 24, 36 months]
  • Median time to regain treatment response [Срок оценки: 12, 24, 36 months]

Критерии участия

Критерии включения

  • Age ≥ 18 years, with a clinical diagnosis of moderate-to-severe plaque psoriasis.
  • Initiated secukinumab treatment at our center between January 2020 and December 2025, and completed the standard 5-week induction period.
  • Achieved PASI 75 response at the end of the induction period.
  • Had a clearly defined maintenance treatment pattern (standard or non-standard), with complete treatment records and regular efficacy assessments.
  • Complete electronic medical record data available for extraction.

Критерии исключения

  • Failure to complete the induction period, or failure to achieve PASI 75 response by the end of the induction period.
  • Irregular maintenance treatment pattern, or substantial missing data.
  • Use of other targeted biologic agents or small molecule drugs during the maintenance period.
  • Permanent discontinuation of treatment for non-efficacy reasons, such as pregnancy, severe infection, or malignancy.
  • Participation in other interventional clinical trials that may confound efficacy assessment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Китай · 1 центр
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medicine School — Нанкин

Публикации

  • Gambardella A, Licata G, Sohrt A. Dose Adjustment of Biologic Treatments for Moderate-to-Severe Plaque Psoriasis in the Real World: A Systematic Review. Dermatol Ther (Heidelb). 2021 Aug;11(4):1141-1156. doi: 10.1007/s13555-021-00559-z. Epub 2021 Jun 3. PMID 34081304
  • Menter A, Papp KA, Gooderham M, Pariser DM, Augustin M, Kerdel FA, Fakharzadeh S, Goyal K, Calabro S, Langholff W, Chavers S, Naessens D, Sermon J, Krueger GG. Drug survival of biologic therapy in a large, disease-based registry of patients with psoriasis: results from the Psoriasis Longitudinal Assessment and Registry (PSOLAR). J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1148-58. doi: 10.1111/jd PMID 27027388
  • Nast A, Altenburg A, Augustin M, Boehncke WH, Harle P, Klaus J, Koza J, Mrowietz U, Ockenfels HM, Philipp S, Reich K, Rosenbach T, Schlaeger M, Schmid-Ott G, Sebastian M, von Kiedrowski R, Weberschock T, Dressler C. German S3-Guideline on the treatment of Psoriasis vulgaris, adapted from EuroGuiDerm - Part 1: Treatment goals and treatment recommendations. J Dtsch Dermatol Ges. 2021 Jun;19(6):934-1 PMID 34139083
  • Blauvelt A, Reich K, Tsai TF, Tyring S, Vanaclocha F, Kingo K, Ziv M, Pinter A, Vender R, Hugot S, You R, Milutinovic M, Thaci D. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017 Jan;76(1):60-69.e9. doi: 10.1016/j.jaad.2016.08.008. Epub 2016 Sep 20. PMID 27663079
  • Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, Puig L, Nakagawa H, Spelman L, Sigurgeirsson B, Rivas E, Tsai TF, Wasel N, Tyring S, Salko T, Hampele I, Notter M, Karpov A, Helou S, Papavassilis C; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. doi: 10.1056/NEJMoa1314258. Epub 2014 PMID 25007392

Идентификаторы

NCT: NCT07642544 · SEMLOP

Первоисточники (государственные реестры)

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