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A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Summary
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.
Official title: Post-marketing Case Registration Study on the Safety and Efficacy of Taibowei® Adalimumab Injection for Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-08-13
Completion Date
2029-03
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
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.
Locations (1)
Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, China