RecruitingPhase 4NCT05906576
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
Enrollment
30 participants
Start Date
Sep 21, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
Eligibility
Min Age: 6 YearsMax Age: 17 Years
Plain Language Summary
Simplified for easier understanding
This is a real-world registry study following Chinese children with Crohn's disease (a chronic inflammatory bowel condition) who are receiving infliximab (a biologic medication) for the first time. The goal is to collect data on how well the drug works and whether it is safe in everyday clinical practice.
**You may be eligible if...**
- You are a child aged 6–17 years with moderate to severe active Crohn's disease
- You have not previously received infliximab
- You or your guardian can provide written consent
**You may NOT be eligible if...**
- You have a serious infection, active tuberculosis, or cancer (lymphoma or other)
- You have moderate-to-severe heart failure
- You are allergic to infliximab or similar medications
- You are already taking another biologic drug targeting the same pathway (anti-TNF)
- You have received a live vaccine within the past 3 months or plan to during treatment
- You are enrolled in another clinical trial
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGInfliximab
Infliximab in the treatment of Crohn's disease in children
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05906576
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