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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 May 2025
• Main ID: NCT04312659
• Date of registration: 03/03/2020
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson (China) Investment Ltd.
• Public title: A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
• Scientific title: A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
• Date of first enrolment: July 15, 2020
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04312659
• Study type: Observational

Countries of recruitment

China

Contacts

• Name: Johnson & Johnson (China) Investment Ltd. Clinical Trial
• Affiliation: Johnson & Johnson (China) Investment Ltd.

Key inclusion & exclusion criteria

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


Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Infliximab

Primary Outcome(s)

Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability [Time Frame: Up to 102 weeks]

Percentage of Participants with Clinical Response at Week 14 [Time Frame: Week 14]

Secondary Outcome(s)

Change from Baseline in Hemoglobin Levels at Week 14 [Time Frame: Baseline and Week 14]

Percentage of Participants with Clinical Response at Week 30 [Time Frame: Week 30]

Change from Baseline in Platelet Count at Week 14 [Time Frame: Baseline and Week 14]

Percentage of Participants with Clinical Remission at Week 14 [Time Frame: Week 14]

Percentage of Participants with Endoscopic Remission at Week 30 [Time Frame: Week 30]

Change from Baseline in Albumin Levels at Week 14 [Time Frame: Baseline and Week 14]

Change from Baseline in White Blood Cells Countat Week 14 [Time Frame: Baseline and Week 14]

Change from Baseline in Body Mass Index (BMI) Z-Scores at Week 30 [Time Frame: Baseline and Week 30]

Change from Baseline in Acute Response Indicators at Week 14 [Time Frame: Baseline and Week 14]

Percentage of Participants with Clinical Remission at Week 30 [Time Frame: Week 30]

Change from Baseline in Height Z-Scores at Week 30 [Time Frame: Baseline and Week 30]

Secondary ID(s)

CR108748

C0168CRD4020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors