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.
Study Type
OBSERVATIONAL
Enrollment
38
Participants will be observed who were treated with Infliximab.
Guangzhou Women And Children's Medical Center
Guangzhou, China
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, China
Children's Hospital of Fudan University
Shanghai, China
Percentage of Participants with Clinical Response at 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.
Time frame: Week 14
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
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.
Time frame: Up to 102 weeks
Percentage of Participants with Clinical Remission at Week 14
Percentage of participants with clinical remission at week 14 will be reported. Clinical remission is defined as the total PCDAI \<=10.
Time frame: Week 14
Percentage of Participants with Clinical Remission at Week 30
Percentage of participants with clinical remission at week 30 will be reported. Clinical remission is defined as the total PCDAI \<=10.
Time frame: Week 30
Percentage of Participants with Clinical Response at 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.
Time frame: Week 30
Percentage of Participants with Endoscopic Remission at 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.
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Henan Children's Hospital, Zhengzhou Children's Hospital
Zhengzhou, China
Time frame: Week 30
Change from Baseline in Height Z-Scores at 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.
Time frame: Baseline and Week 30
Change from Baseline in Body Mass Index (BMI) Z-Scores at 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).
Time frame: Baseline and Week 30
Change from Baseline in Acute Response Indicators at Week 14
Change from baseline in acute response indicators (C response protein and erythrocyte sedimentation rate) at week 14 will be reported.
Time frame: Baseline and Week 14
Change from Baseline in White Blood Cells Countat Week 14
Change from baseline in white blood cells count (giga cells per liter) at week 14 and will be reported.
Time frame: Baseline and Week 14
Change from Baseline in Hemoglobin Levels at Week 14
Change from baseline in hemoglobin levels (grams per liter) will be reported at week 14.
Time frame: Baseline and Week 14
Change from Baseline in Platelet Count at Week 14
Change from baseline in platelet count (giga cells per liter) will be reported at week 14.
Time frame: Baseline and Week 14
Change from Baseline in Albumin Levels at Week 14
Change from baseline in albumin levels (grams per liters) will be reported at week 14.
Time frame: Baseline and Week 14