Post - Marketing Case Registration Study on the Safety and Efficacy of Adalimumab Solution for Injection in Chinese Pediatric Patients With Moderate - to - Severe Active Crohn's Disease

Обзор

This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.

Вмешательства

• Препарат Adalimumab Solution for Injection
  Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor-α (TNF-α), a core inflammatory factor in psoriasis.

Первичные конечные точки

• The incidence of adverse events (AE), adverse drug reactions (ADR), adverse events of special interest (AESI) and serious ADR at 12, 26 and 52 weeks after treatment [Срок оценки: Weeks 12, 26, 52]

Вторичные конечные точки (7)

• Proportion of patients with clinical remission patients with moderate - to - severe active Crohn's disease in the real - world setting. [Срок оценки: Weeks 12, 26, 52]
• Proportion of patients with clinical response [Срок оценки: Weeks 12, 26, 52]
• Changes in C-reactive protein (CRP) levels [Срок оценки: Weeks 12, 26, 52]
• Changes in fecal calprotectin (FC) levels [Срок оценки: Weeks 12, 26, 52]
• Effective trough concentration of adalimumab [Срок оценки: week 4]
• Growth and development of pediatric patients-Weight [Срок оценки: Weeks 12, 26, 52]
• Growth and development of pediatric patients-Height [Срок оценки: Weeks 12, 26, 52]

Критерии участия

Критерии включения

• Age is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender.
• Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the "Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019".
• (3) Pediatric Crohn's disease patients who have been prescribed Adalimumab Solution for Injection by doctors after a full assessment of risks/benefits.Both the patient and their guardian must sign the informed consent form. The research protocol/informed consent form used for data collection and data verification should comply with local laws and regulatory requirements.

Критерии исключения

• (1) According to the instruction manual of Adalimumab Solution for Injection and the judgment of the treating physician, the patient is not suitable for treatment with Adalimumab Solution for Injection.
• (2) Pediatric Crohn's disease patients who have received any live vaccines within 3 months prior to the first dose of Adalimumab Solution for Injection or who plan to receive any live vaccines during the study period.
• Patients who are participating in other clinical studies. (4) Patients whom the investigator deems unsuitable for participation in this trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07564505 · ADM-IV-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗