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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05906576
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Taizhou Mabtech Pharmaceutical Co.,Ltd

Study Description
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Brief Summary:
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Infliximab Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Actual Study Start Date : September 21, 2023
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Arms and Interventions
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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 Name: CMAB008


Outcome Measures
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Primary Outcome Measures :
  1. Clinical response rate at 14 weeks [ Time Frame: up to 14 weeks ]
    Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points


Secondary Outcome Measures :
  1. Clinical remission rate at week 14 and 54 [ Time Frame: up to 54 weeks ]
    Clinical remission: PCDAI≤10

  2. Endoscopic response rate at week 14 and 54 [ Time Frame: up to 54 weeks ]
    Endoscopic response: SES-CD decreased ≥ 50%

  3. Mucosal healing rate at week 14 and 54 [ Time Frame: up to 54 weeks ]
    Mucosal healing: SES-CD 0-2

  4. 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 [ Time Frame: up to 54 weeks ]
    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.

  5. Changes from baseline in serum C-reactive protein at week 14 and 54 [ Time Frame: up to 54 weeks ]
    Changes from baseline in serum C-reactive protein at week 14 and 54

  6. Changes from baseline in erythrocyte sedimentation rate at week 14 and 54 [ Time Frame: up to 54 weeks ]
    Changes from baseline in erythrocyte sedimentation rate at week 14 and 54

  7. Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks [ Time Frame: up to 54 weeks ]
    Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I

  8. ADA positive rate [ Time Frame: up to 54 weeks ]
    ADA positive rate at week 14 and 54

  9. Percentage of participants with Adverse Events [ Time Frame: up to 102 weeks ]
    Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05906576


Contacts
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Contact: Wu Jie 18940251108 licli2860@sina.com

Locations
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China
Beijing Children's Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Wu Jie    18940251108    licli2860@sina.com   
Sponsors and Collaborators
Taizhou Mabtech Pharmaceutical Co.,Ltd
Investigators
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Principal Investigator: Wu Jie Beijing Children's Hospital
More Information
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Responsible Party: Taizhou Mabtech Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT05906576    
Other Study ID Numbers: C008CDIV
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Infliximab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents