Status:
COMPLETED
A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
Lead Sponsor:
Johnson & Johnson (China) Investment Ltd.
Conditions:
Crohn Disease
Eligibility:
All Genders
6-17 years
Brief Summary
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 effica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 12 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04312659
Start Date
July 15 2020
End Date
September 12 2023
Last Update
April 27 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Guangzhou Women And Children's Medical Center
Guangzhou, China, 510623
2
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, China, 310052
3
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, China, 200025
4
Children's Hospital of Fudan University
Shanghai, China, 201102