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Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

NCT00984568 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2017-04-13

Study results available
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Summary

This study will be performed to compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate-to-severe active ulcerative colitis using oral prednisolone + oral 5-aminosalicylic acid (5-ASA) or oral prednisolone + oral azathioprine (AZA) with a more intensive and early "Top-Hold" approach with intravenous infliximab (5 mg/kg) administered at Weeks 0, 2, and 6 and 8 weeks thereafter.

Conditions

  • Colitis, Ulcerative

Interventions

BIOLOGICAL

Infliximab

Infliximab intravenous infusion at a dose of 5 mg/kg.

DRUG

Prednisolone

Oral prednisolone 40 mg/day or 1 mg/kg/day depending upon participant response.

DRUG

5-aminosalicylic acid

5-ASA administered orally at a dose of 2 g/day.

DRUG

Azathioprine

AZA administered orally at a dose of 2.0-2.5 mg/kg/day.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00984568 on ClinicalTrials.gov