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Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

NCT05906576•Taizhou Mabtech Pharmaceutical Co.,Ltd

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a prospective, multicenter registry study in Chinese pediatric Crohn's disease patients. A total of 30 subjects were planned to be enrolled and treated with Infliximab. Subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with Crohn's disease in a real diagnostic setting.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Beijing Children's Hospital, Capital Medical University

Beijing, China

Key Dates

Start Date

September 21, 2023

Primary Completion Date

November 1, 2026

Completion Date

February 1, 2027

Last Updated

May 22, 2025

Enrollment

ESTIMATED participants

Conditions

Crohn Disease

Interventions

Infliximab

DRUG

Contacts

Wu Jie

CONTACT

18940251108 licli2860@sina.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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