Clinical trial NCT04312659: A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
Official title: A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Lead sponsor: Johnson & Johnson (China) Investment Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants observed in this study will be pediatric participants with Crohn's disease who have signed the ICF and are treated with infliximab.

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 efficacy and safety of IFX in the treatment of pediatric CD.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants with Clinical Response at Week 14
timeFrame: Week 14
measure: Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
timeFrame: Up to 102 weeks
Secondary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 14
timeFrame: Week 14
measure: Percentage of Participants with Clinical Remission at Week 30
timeFrame: Week 30
measure: Percentage of Participants with Clinical Response at Week 30
timeFrame: Week 30
measure: Percentage of Participants with Endoscopic Remission at Week 30
timeFrame: Week 30
measure: Change from Baseline in Height Z-Scores at Week 30
timeFrame: Baseline and Week 30
measure: Change from Baseline in Body Mass Index (BMI) Z-Scores at Week 30
timeFrame: Baseline and Week 30
measure: Change from Baseline in Acute Response Indicators at Week 14
timeFrame: Baseline and Week 14
measure: Change from Baseline in White Blood Cells Countat Week 14
timeFrame: Baseline and Week 14
measure: Change from Baseline in Hemoglobin Levels at Week 14
timeFrame: Baseline and Week 14
measure: Change from Baseline in Platelet Count at Week 14
timeFrame: Baseline and Week 14
measure: Change from Baseline in Albumin Levels at Week 14
timeFrame: Baseline and Week 14
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women And Children's Medical Center
city: Hangzhou
country: China
facility: The Childrens Hospital Zhejiang University School Of Medicine
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
city: ZhengZhou
country: China
facility: Henan Children's Hospital, Zhengzhou Children's Hospital
Study officials:
affiliation: Johnson & Johnson (China) Investment Ltd.
name: Johnson & Johnson (China) Investment Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: