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Completed

NCT Number: NCT04312659

A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

The main purpose of this study is to record the use of Infliximab (IFX) in the treatment of Chinese children with Crohn's disease (CD) in routine clinical practice and to summarize the clinical efficacy and safety of IFX in the treatment of pediatric CD.

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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

Observational

Primary location

Guangzhou Women And Children's Medical Center, Guangzhou, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have a confirmed diagnosis of Crohn's disease
  • Must sign, and their legal guardians/legally-acceptable representative where applicable must sign, a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements
  • First-time received IFX treatment

Exclusion criteria

  • History of medical contraindications for Infliximab (IFX), example. serious infections, active tuberculosis (TB), lymphoma and other malignancies, moderate to severe heart failure, hypersensitivity to inactive components of the product or to any murine proteins
  • Previous exposure to Infliximab or any other biologics
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point
  • Currently enrolled in an investigational study
  • Have other Crohn's-like disease that are associated with mono-genetic immune disorders

Treatment and study plan

Infliximab

Drug

Participants will be observed who were treated with Infliximab.

Primary outcomes

  1. Percentage of Participants with Clinical Response at Week 14

    Time frame: Week 14

    Percentage of participants with clinical response at week 14 will be reported. Clinical response is defined as a decrease of PCDAI >=15 and total PCDAI <=30.

  2. Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability

    Time frame: Up to 102 weeks

    An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Secondary outcomes

  1. Percentage of Participants with Clinical Remission at Week 14

    Time frame: Week 14

    Percentage of participants with clinical remission at week 14 will be reported. Clinical remission is defined as the total PCDAI <=10.

  2. Percentage of Participants with Clinical Remission at Week 30

    Time frame: Week 30

    Percentage of participants with clinical remission at week 30 will be reported. Clinical remission is defined as the total PCDAI <=10.

  3. Percentage of Participants with Clinical Response at Week 30

    Time frame: Week 30

    Percentage of participants with clinical response at week 30 will be reported. Clinical response defined as a decrease of PCDAI >=15 and total PCDAI<=30.

  4. Percentage of Participants with Endoscopic Remission at Week 30

    Time frame: Week 30

    Percentage of participants with endoscopic remission at week 30 will be reported. Endoscopic remission is defined as a total simple endoscopic sore for CD (SES-CD) 0-2. SES-CD is an endoscopic scoring system for CD. It is based on the score of 0-3 of the following four endoscopic variables: ulcer size, ulcerated and affected surfaces, and stenosis determined in five ileocolonic segment.

  5. Change from Baseline in Height Z-Scores at Week 30

    Time frame: Baseline and Week 30

    Change from baseline in height Z-score will be recorded directly into an electronic device and will be considered source data. Height will be measured in meters.

  6. Change from Baseline in Body Mass Index (BMI) Z-Scores at Week 30

    Time frame: Baseline and Week 30

    Change from baseline in BMI Z-score (growth and development) will be recorded directly into an electronic device and will be considered source data. BMI will be calculated based on weight (kilograms)/height (meters square).

  7. Change from Baseline in Acute Response Indicators at Week 14

    Time frame: Baseline and Week 14

    Change from baseline in acute response indicators (C response protein and erythrocyte sedimentation rate) at week 14 will be reported.

  8. Change from Baseline in White Blood Cells Countat Week 14

    Time frame: Baseline and Week 14

    Change from baseline in white blood cells count (giga cells per liter) at week 14 and will be reported.

  9. Change from Baseline in Hemoglobin Levels at Week 14

    Time frame: Baseline and Week 14

    Change from baseline in hemoglobin levels (grams per liter) will be reported at week 14.

  10. Change from Baseline in Platelet Count at Week 14

    Time frame: Baseline and Week 14

    Change from baseline in platelet count (giga cells per liter) will be reported at week 14.

  11. Change from Baseline in Albumin Levels at Week 14

    Time frame: Baseline and Week 14

    Change from baseline in albumin levels (grams per liters) will be reported at week 14.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson (China) Investment Ltd.

Industry

Registry information

Official study title

A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2020
Registry last updated
Apr 27, 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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