RecruitingPhase 4NCT05043870

Combined Immunosuppression for Pediatric Crohn's Disease

Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease


Sponsor

Children's Hospital of Fudan University

Enrollment

128 participants

Start Date

Oct 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a biologic drug (either anti-TNF therapy or ustekinumab) alongside an immune-modulating drug at the start of treatment produces better results than standard step-up therapy for children with moderate-to-severe Crohn's disease. **You may be eligible if...** - Your child is between 6 and 18 years old with a diagnosis of Crohn's disease - Their Crohn's disease is moderately to severely active (PCDAI score above 30 or endoscopy score above 10) - Their disease did not adequately improve after initial treatment with nutritional therapy or steroids - They have not previously received biologic drugs targeting TNF **You may NOT be eligible if...** - Your child has previously received a biologic anti-TNF drug - Your child has had Crohn's disease-related surgery - Your child has active infections or a tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInfliximab 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

DRUGInfliximab

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


Locations(1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT05043870


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