Adalimumab in Children with Crohn’s Disease (Pediatric 6–17)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a real-world, open-label study enrolling 30 pediatric patients to evaluate safety outcomes after Adalimumab treatment. The trial will track serious adverse events, adverse events, adverse drug reactions, and adverse events of special interest at 12, 26, and 52 weeks. Participants must have documented moderate-to-severe Crohn’s disease and be prescribed Adalimumab by their doctors. The study is conducted at a single site in Guangzhou, China, under local regulatory guidelines. Enrollment is limited to patients receiving Adalimumab as part of standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* (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.

Where it's running

• Women and Children's Medical Center, Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Lanlan Geng, Doctor
• Email: 13622237569@163.com
• Phone: 18902268612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.