NCT00554710

Top Down Versus Step Up Strategies in Crohn's Disease

The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This two year open-label randomized trial compares the early use of combined immunosuppression to conventional management in patients with active Crohn's disease who have not previously received glucocorticoids, antimetabolites, or infliximab. Patients assigned to combined immunosuppression receive azathioprine and 3 infusions of 5 milligrams per kilogram of body weight of infliximab at weeks 0, 2, and 6. Retreatment with infliximab and, if ultimately necessary, corticosteroids are used to control disease activity. Patients assigned to conventional management receive corticosteroids followed, in sequence, by azathioprine and infliximab. The primary outcome measure is remission without corticosteroids and without bowel resection at weeks 26 and 52.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-05-01
• Completion: 2004-01-01
• First posted: 2007-11-07
• Last updated: 2007-11-07

Locations

1 site across 1 country: Belgium