Combined Immunosuppression for Pediatric Crohn's Disease

Fudan University

Status and phase: Enrolling; Phase 4

Conditions: Children, Only; Immunosuppression; Infliximab; Crohn Disease

Treatments: Drug: Infliximab; Drug: Infliximab and immunosuppressives

Study type: Interventional

Funder types: Other

Identifiers

NCT05043870

Combined therapy in CD

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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
5. The patient or legal guardian sign the informed consent documents

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

infliximab and immunosuppressives therapy

Experimental group

Description:

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

Treatment:

Drug: Infliximab and immunosuppressives

infliximab therapy

Active Comparator group

Description:

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

Treatment:

Drug: Infliximab