Back to resultsPost-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Primary Purpose
Crohn Disease
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Beijing Children's Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Infliximab
Arm Description
Infliximab for the treatment of Crohn's disease in children
Outcomes
Primary Outcome Measures
Clinical response rate at 14 weeks
Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
Secondary Outcome Measures
Clinical remission rate at week 14 and 54
Clinical remission: PCDAI≤10
Endoscopic response rate at week 14 and 54
Endoscopic response: SES-CD decreased ≥ 50%
Mucosal healing rate at week 14 and 54
Mucosal healing: SES-CD 0-2
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.
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
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
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
ADA positive rate
ADA positive rate at week 14 and 54
Percentage of participants with Adverse Events
Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Full Information
NCT ID
NCT05906576
First Posted
June 2, 2023
Last Updated
June 13, 2023
Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05906576
Brief Title
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Official Title
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infliximab
Arm Type
Experimental
Arm Description
Infliximab for the treatment of Crohn's disease in children
Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
CMAB008
Intervention Description
Infliximab in the treatment of Crohn's disease in children
Primary Outcome Measure Information:
Title
Clinical response rate at 14 weeks
Description
Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
Time Frame
up to 14 weeks
Secondary Outcome Measure Information:
Title
Clinical remission rate at week 14 and 54
Description
Clinical remission: PCDAI≤10
Time Frame
up to 54 weeks
Title
Endoscopic response rate at week 14 and 54
Description
Endoscopic response: SES-CD decreased ≥ 50%
Time Frame
up to 54 weeks
Title
Mucosal healing rate at week 14 and 54
Description
Mucosal healing: SES-CD 0-2
Time Frame
up to 54 weeks
Title
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
Description
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.
Time Frame
up to 54 weeks
Title
Changes from baseline in serum C-reactive protein at week 14 and 54
Description
Changes from baseline in serum C-reactive protein at week 14 and 54
Time Frame
up to 54 weeks
Title
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Description
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Time Frame
up to 54 weeks
Title
Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks
Description
Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I
Time Frame
up to 54 weeks
Title
ADA positive rate
Description
ADA positive rate at week 14 and 54
Time Frame
up to 54 weeks
Title
Percentage of participants with Adverse Events
Description
Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Time Frame
up to 102 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Jie
Phone
18940251108
Email
licli2860@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Jie
Organizational Affiliation
Beijing Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
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