Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients

Recruiting now · Phase 4

Conditions studied: Crohn Disease

In brief

Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.

Key facts

Study ID: NCT05906576
Run by: Taizhou Mabtech Pharmaceutical Co.,Ltd
People needed: 30
Starts: 2023-09-21
Expected to finish: 2027-02-01
Last updated by the study team: 2025-05-22

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ranged 6 to 17 years (both inclusive), no gender limitation.
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).
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.
The patient received infliximab for the first time.

You may not qualify if…

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.
Those who accept other anti-TNF-α any biological drugs or any other biologicals.
Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
The investigator judges the subject inappropriate to be included in this study.

Where it is running

Beijing Children's Hospital, Capital Medical University — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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