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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906576
• Other study ID #: C008CDIV
• Status: Recruiting
• Phase: Phase 4
• Start date: September 21, 2023
• Est. completion date: February 2027

Study information

• Verified date: April 2024
• Source: Taizhou Mabtech Pharmaceutical Co.,Ltd
• Contact: Wu Jie
• Phone: 18940251108
• Email: licli2860[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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-a 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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Infliximab
Infliximab in the treatment of Crohn's disease in children

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Mabtech Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate at 14 weeks	Clinical response: PCDAI decreased =15 points and total PCDAI= 30 points	up to 14 weeks
Secondary	Clinical remission rate at week 14 and 54	Clinical remission: PCDAI=10	up to 54 weeks
Secondary	Endoscopic response rate at week 14 and 54	Endoscopic response: SES-CD decreased = 50%	up to 54 weeks
Secondary	Mucosal healing rate at week 14 and 54	Mucosal healing: SES-CD 0-2	up to 54 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ADA positive rate	ADA positive rate at week 14 and 54	up to 54 weeks
Secondary	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