Top Down Versus Step Up Strategies in Crohn's Disease

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belgian IBD Research Group; Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
• Collaborators: Centocor BV; Schering-Plough
• Treatments: Azathioprine; Budesonide; Infliximab; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• age 16 - 75 years

• diagnosis of Crohn's disease within the past 4 years

• no previous treatment with corticosteroids, antimetabolites, or biologic agents.

• Active Crohn's disease, defined by a Crohn's Disease Activity Index (CDAI)20 score of greater than 200 points for a minimum of 2 weeks prior to randomization.

Exclusion Criteria:

• immediate need for surgery

• symptomatic stenosis or ileal/colonic strictures with prestenotic dilatation;

• signs, symptoms or laboratory tests indicating severe, medical disease;

• documented chronic infection

• a positive stool culture for pathogens

• a positive tuberculin test or a chest radiograph consistent with tuberculosis.

• malignancy

• allergy to murine proteins

• pregnancy

• substance abuse