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Top Down Versus Step Up Strategies in Crohn's Disease

NCT00554710 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2007-11-07

No results posted yet for this study

Summary

The study prospectively compares two treatment algorithms for newly diagnosed Crohn's disease: one 'aggressive' treatment with early introduction of immunomodulators and biologicals and one 'standard treatment' with corticosteroids and only later introduction of immunosuppressives and biologicals if disease activity requires that.

Conditions

Interventions

DRUG

infliximab+azathioprine

infliximab 5 mg/kg at week 0,2 and 6 + azathioprine 2-2.5 mg/kg

DRUG

methylprednisolone or budesonide

methylprednisolone 32 mg followed by taper or budesonide 9 mg/day followed by taper

Sponsors & Collaborators

  • Centocor BV

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

    lead OTHER

Principal Investigators

  • Geert R DHaens, MD, PhD · Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Completion
2004-01-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

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 NCT00554710 on ClinicalTrials.gov