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

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

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Infliximab

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wu Jie; Phone Number: 18940251108; Email: licli2860@sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Children's Hospital, Capital Medical University
    • Contact: Wu Jie; Phone Number: 18940251108; Email: licli2860@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infliximab; Infliximab for the treatment of Crohn's disease in children	Drug: Infliximab; Infliximab in the treatment of Crohn's disease in children; Other Names: CMAB008

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical response rate at 14 weeks	Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points	up to 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical remission rate at week 14 and 54	Clinical remission: PCDAI≤10	up to 54 weeks
Endoscopic response rate at week 14 and 54	Endoscopic response: SES-CD decreased ≥ 50%	up to 54 weeks
Mucosal healing rate at week 14 and 54	Mucosal healing: SES-CD 0-2	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	The z-score is converted from anthropometric measurements based on the World Health Organization growth reference. The z-score including: height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score.	up to 54 weeks
Changes from baseline in serum C-reactive protein at week 14 and 54	Changes from baseline in serum C-reactive protein at week 14 and 54	up to 54 weeks
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54	Changes from baseline in erythrocyte sedimentation rate at week 14 and 54	up to 54 weeks
Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks	Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I	up to 54 weeks
ADA positive rate	ADA positive rate at week 14 and 54	up to 54 weeks
Percentage of participants with Adverse Events	Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study	up to 102 weeks

Collaborators and Investigators

• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
• Investigators: Principal Investigator: Wu Jie, Beijing Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Tumor Necrosis Factor Inhibitors; Infliximab
• Other Study ID Numbers: C008CDIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No