Combined Immunosuppression for Pediatric Crohn's Disease

Study Purpose

This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.

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.

Interventional
Eligible Ages 6 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 6-18 years old. 2. diagnosis of Crohn's Disease. 3. Pediatric Crohn's disease Activity Index (PCDAI)>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) >10 before treatment. 4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids.

Exclusion Criteria:

1. history of biological agents targeting at tumor necrosis factor (TNF) 2. Crohn's Disease-related surgery. 3. infections. 4. tumors

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.

NCT05043870
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.

Phase 4
Lead Sponsor

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

Children's Hospital of Fudan University
Principal Investigator

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

Ying Huang
Principal Investigator Affiliation Children's Hospital of Fudan University
Agency Class

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

Other
Overall Status Not yet recruiting
Countries
Conditions

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

Crohn Disease, Infliximab, Immunosuppression, Children, Only
Arms & Interventions

Arms

Experimental: infliximab and immunosuppressives therapy

the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week

Active Comparator: infliximab therapy

the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks

Interventions

Drug: - Infliximab and immunosuppressives

the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week

Drug: - Infliximab

the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Lin Wang

wanglin546974055@163.com

+8613817510412

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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