Health TrialsbyHealthPanel

Combined Immunosuppression for Pediatric Crohn's Disease

ConditionsCrohn DiseaseInfliximabImmunosuppressionChildren, Only
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-18
SponsorChildren's Hospital of Fudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

history of biological agents targeting at tumor necrosis factor (TNF)

Crohn's Disease-related surgery

infections

tumors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Infliximab and immunosuppressives

    Drug

    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

  • Infliximab

    Drug

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

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: infliximab and immunosuppressives therapyExperimental treatment 1 intervention
Group B: infliximab therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

clinical remission

The clinical remission rate at week 54

Time frame
week 54
2

endoscopic remission

The endoscopic remission rate at week 54

Time frame
week 54

Secondary outcomes

1

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.

Time frame
week0, week2, week6, week14, week22, week30, week38, week46, week54

Other outcomes

1

infliximab concentration

The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38.

Time frame
week 14, 38
2

adverse events

The rate of the potential adverse events were monitored during the intervention.

Time frame
within one year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov
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