NCT04312659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

3.2 years

First QC Date

March 3, 2020

Last Update Submit

April 25, 2025

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (11)

  • Percentage of Participants with Clinical Remission at Week 14

    Week 14

  • Percentage of Participants with Clinical Remission at Week 30

    Week 30

  • Percentage of Participants with Clinical Response at Week 30

    Week 30

  • Percentage of Participants with Endoscopic Remission at Week 30

    Week 30

  • Change from Baseline in Height Z-Scores at Week 30

    Baseline and Week 30

  • +6 more secondary outcomes

Study Arms (1)

Infliximab

Participants with pediatric Crohn's disease (CD) who were treated with Infliximab (IFX) and signed the Informed Consent Form (ICF) for the study will be enrolled case by case. Each participants will be followed up for at least 30 weeks. After 30 weeks, participants continuing IFX treatment will be followed up, with a maximum follow-up period of 102 weeks. The primary data source will be participants medical records for all data entered into the CRF.

Drug: Infliximab

Interventions

InfliximabDRUG

Participants will be observed who were treated with Infliximab.

Infliximab

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Guangzhou Women And Children's Medical Center

Guangzhou, 510623, China

Location

The Childrens Hospital Zhejiang University School Of Medicine

Hangzhou, 310052, China

Location

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025, China

Location

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

Henan Children's Hospital, Zhengzhou Children's Hospital

Zhengzhou, 450018, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Johnson & Johnson (China) Investment Ltd. Clinical Trial

    Johnson & Johnson (China) Investment Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 18, 2020

Study Start

July 15, 2020

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations

CN(5)