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

NCT05906576 | Recruiting Phase 4

• 1 other identifier: C008CDIV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Clinical response rate at 14 weeks

  Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points

  up to 14 weeks

Secondary Outcomes (9)

• Clinical remission rate at week 14 and 54

  up to 54 weeks

• Endoscopic response rate at week 14 and 54

  up to 54 weeks

• Mucosal healing rate at week 14 and 54

  up to 54 weeks

• Changes from baseline in height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score at week 14 and 54

  up to 54 weeks

• Changes from baseline in serum C-reactive protein at week 14 and 54

  up to 54 weeks

Study Arms (1)

Infliximab

EXPERIMENTAL

Infliximab for the treatment of Crohn's disease in children

Drug: Infliximab

Interventions

Infliximab DRUG

Infliximab in the treatment of Crohn's disease in children

Also known as: CMAB008

Infliximab

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Beijing Children's Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Wu Jie

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wu Jie

CONTACT

18940251108; licli2860@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 18, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)