drugset / Trial / NCT00554710

Top Down Versus Step Up Strategies in Crohn's Disease

NCT00554710

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2001-05
Primary completion
Completion
2004-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule 2 mg/kg
Subject Azathioprine Small molecule 2 mg
Subject Azathioprine Small molecule 2.5 mg/kg
Subject Azathioprine Small molecule 2.5 mg
Comparator Budesonide Small molecule 9 mg
Subject Infliximab Monoclonal antibody 5 mg/kg Intravenous
Comparator Methylprednisolone Other / unclassified 32 mg
Comparator Methylprednisolone Other / unclassified 64 mg

Indications