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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04312659
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Johnson & Johnson (China) Investment Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Johnson & Johnson (China) Investment Ltd. Clinical Trial
Principal Investigator Affiliation Johnson & Johnson (China) Investment Ltd.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions

Arms

: 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.

Interventions

Drug: - Infliximab

Participants will be observed who were treated with Infliximab.

Contact a Trial Team

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International Sites

Hangzhou, China

Status

Address

The Children's Hospital, Zhejiang University School Of Medicine

Hangzhou, , 310052

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