Registry of Infliximab for Children with Crohn's Disease in China

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 prospective, multicenter registry that aims to evaluate the clinical efficacy and safety of Infliximab in treating pediatric patients with moderate to severe active Crohn's disease in China. A total of 30 subjects aged 6 to 17 years will be enrolled and treated with Infliximab, with follow-up observations conducted for 102 weeks. The study focuses on real-world outcomes to provide insights into the treatment of Crohn's disease in children.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ranged 6 to 17 years (both inclusive), no gender limitation.
2. A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
3. Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
4. The patient received infliximab for the first time.

Exclusion Criteria:

1. Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.
2. Those who accept other anti-TNF-α any biological drugs or any other biologicals.
3. Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
4. Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
5. The investigator judges the subject inappropriate to be included in this study.

Where it's running

• Beijing Children's Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Principal investigator: Wu Jie — Beijing Children's Hospital
• Study coordinator: Wu Jie
• Email: licli2860@sina.com
• Phone: 18940251108

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining treatments for children with Crohn's disease

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• Microencapsulated Propionate vs Butyrate for Crohn's Disease in Remission

  This study tests whether microencapsulated sodium propionate can favorably alter the gut microbiota and inflammation in adults with Crohn’s disease, compared with sodium butyrate.

  Recruiting University of Padova · Padova · NCT07883044

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.