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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 February 2021
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: 30
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04312659
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
China
Contacts
Name:     Study Contact
Address: 
Telephone: 844-434-4210
Email: JNJ.CT@sylogent.com
Affiliation: 
Name:     Johnson & Johnson (China) Investment Ltd. Clinical Trial
Address: 
Telephone:
Email:
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 Acute Response Indicators at Week 14 [Time Frame: Baseline and Week 14]
Change from Baseline in Albumin Levels at 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 Height Z-Scores at Week 30 [Time Frame: Baseline and Week 30]
Change from Baseline in Hemoglobin Levels at Week 14 [Time Frame: Baseline and Week 14]
Change from Baseline in Platelet Count 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]
Percentage of Participants with Clinical Remission at Week 14 [Time Frame: Week 14]
Percentage of Participants with Clinical Remission at Week 30 [Time Frame: Week 30]
Percentage of Participants with Clinical Response at Week 30 [Time Frame: Week 30]
Percentage of Participants with Endoscopic Remission at Week 30 [Time Frame: Week 30]
Secondary ID(s)
C0168CRD4020
CR108748
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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