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NCT Number: NCT05906576

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Children's Hospital, Capital Medical University

Beijing, China

Location status: Recruiting

Location contact

Wu Jie

CONTACT

[email protected]

18940251108

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infliximab

Drug

Infliximab in the treatment of Crohn's disease in children

Other names: CMAB008

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Wu Jie

CONTACT

[email protected]

18940251108

Sponsors and collaborators

Lead sponsor

Taizhou Mabtech Pharmaceutical Co.,Ltd

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2023
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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