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

Crohn Disease Clinical Trial

Official title:

A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312659
• Other study ID #: CR108748
• Secondary ID: C0168CRD4020
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: September 12, 2023

Study information

• Verified date: October 2023
• Source: Johnson & Johnson (China) Investment Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Infliximab
Participants will be observed who were treated with Infliximab.

Locations

Country	Name	City	State
China	Guangzhou Women And Children's Medical Center	Guangzhou
China	The Children's Hospital, Zhejiang University School Of Medicine	Hangzhou
China	Children's Hospital of Fudan University	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University	Shanghai
China	Henan Children's Hospital, Zhengzhou Children's Hospital	ZhengZhou

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson (China) Investment Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 14
Primary	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.	Up to 102 weeks
Secondary	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.	Week 14
Secondary	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.	Week 30
Secondary	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.	Week 30
Secondary	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.	Week 30
Secondary	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.	Baseline and Week 30
Secondary	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).	Baseline and Week 30
Secondary	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.	Baseline and Week 14
Secondary	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.	Baseline and Week 14
Secondary	Change from Baseline in Hemoglobin Levels at Week 14	Change from baseline in hemoglobin levels (grams per liter) will be reported at week 14.	Baseline and Week 14
Secondary	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.	Baseline and Week 14
Secondary	Change from Baseline in Albumin Levels at Week 14	Change from baseline in albumin levels (grams per liters) will be reported at week 14.	Baseline and Week 14