Adalimumab injection for children with moderate to severe Crohn's disease in China
Checks the safety of adalimumab in children with active Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT07564505, who can take part
Where in China
- Women and Children's Medical Center, Guangzhou Medical UniversityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07564505
- Record updated
- 10 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: (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.