Combined Immunosuppression for Pediatric Crohn's Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn Disease, Infliximab, Immunosuppression, Children, Only

Intervention / Treatment
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* Drug: Infliximab and immunosuppressives
* Drug: Infliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-18 years old diagnosis of Crohn's Disease Pediatric Crohn's disease Activity Index (PCDAI)>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) >10 before treatment 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 The patient or legal guardian sign the informed consent documents Exclusion Criteria: history of biological agents targeting at tumor necrosis factor (TNF) Crohn's Disease-related surgery infections tumors

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infliximab and immunosuppressives therapy<br>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 | Drug: Infliximab and immunosuppressives<br>* 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<br>* Other names: IFX, IMMs, AZA, MTX;|
| Active Comparator: infliximab therapy<br>the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks | Drug: Infliximab<br>* the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks<br>* Other names: IFX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical remission | The clinical remission rate at week 54 | week 54 | 
| endoscopic remission | The endoscopic remission rate at week 54 | week 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Crohn's disease Activity Index score | The Pediatric Crohn's disease Activity Index (PCDAI) was assessed at each infusion point. PCDAI score ranges from 0 to 100, the higher means the worse outcome. | week0, week2, week6, week14, week22, week30, week38, week46, week54 |