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

ConditionCrohn Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-17
SponsorTaizhou Mabtech Pharmaceutical Co.,Ltd

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Infliximab

Treatment groups

30 Participants
are divided into 1 treatment group