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Top Down Versus Step up in Pediatric Ulcerative Colitis

ConditionsUlcerative ColitisInfliximabChildren
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-18
SponsorChildren's Hospital of Fudan University

About this trial

Pediatric Ulcerative Colitis (UC) patients with moderate to severe disease activity at high risk of colectomy. Early use of biologic agents will likely be more effective. But there were no studies identified that compared a strategy of upfront biologic-based therapy versus gradual step-up therapy. In our study, newly diagnosed moderate to severe pediatric UC patients (6-18 years old) will be randomly divided into infliximab (IFX) treatment group (Top down group, TD) and corticosteroids (CS) treatment group (Step-up group, SU). Mucosal healing rate at week 12 will be compared between the two groups. The relapse rates and sustained durations of remission within one year will also be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

newly diagnosed UC;

moderate to severe disease activity

Age: 6 to 18 years old

Disqualifiers

with mild disease activity

Have been treated with Corticosteroid or biological agents for UC

Trial design

Design model

Parallel

Treatments tested in this trial

  • Infliximab

    Drug

    Infliximab will be administered intravenously at a dose of 5 mg/kg for 0, 2, and 6 weeks, then every 8 weeks for 1 year.

  • Corticosteroids

    Drug

    Corticosteroid will be given at a dose of 1-2mg/kg/day (maximum 60 mg/kg/day),oral or intravenously for 12 to 14 weeks.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Infliximab treatment groupExperimental treatment 1 intervention
Group B: Corticosteroid treatment groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mucosal healing rate

The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≦1 points is defined as mucosal healing. This will be evaluated by inflammatory bowel disease endoscopist.

Time frame
12 week after intervention

Secondary outcomes

1

The relapse rates

Relapse is defined as an increased in pediatric Ulcerative Colitis activity index (PUCAI) score by 10 points or more after clinical remission or when new Ulcerative Colitis treatment needed to be started due to worsening of symptoms. This will be evaluated by gastroenterologist.

Time frame
1 year after intervention
2

Sustained durations of remission

Sustained pediatric Ulcerative Colitis activity index (PUCAI) score \<10 points during follow-up（week 10 to week 54 after intervention). This will be evaluated by gastroenterologist.

Time frame
1 year after intervention

Other outcomes

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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