Registry of Infliximab for Children with Crohn's Disease in China
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
This study is testing how well Infliximab works and how safe it is for children aged 6 to 17 with moderate to severe Crohn's disease in China.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Taizhou Mabtech Pharmaceutical Co.,Ltd Industry-sponsored |
| Drugs / interventions | infliximab |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05906576 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 17 years diagnosed with moderate to severe active Crohn's disease.
Not a fit: Patients with contraindications to Infliximab or those receiving other anti-TNF-α therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable data on the effectiveness and safety of Infliximab for managing Crohn's disease in pediatric patients.
How similar studies have performed: Other studies have shown positive outcomes with Infliximab in treating Crohn's disease, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.