Top Down Versus Step Up Strategies in Crohn's Disease

Phase 4 Completed 129 enrolled Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW Centocor, Inc. · collab Schering-Plough · collab

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

Outcome

Met primary endpoint

paper absolute difference of 24.1% (95% CI 7.3-40.8, p=0.0062). PMID 18295023 ↗

paper Combined immunosuppression was more effective than conventional management for induction of remission and reduction of corticosteroid use PMID 18295023 ↗

Publications

D'Haens G, Baert F, van Assche G, Caenepeel P, Vergauwe P, Tuynman H, De Vos M, van Deventer S, Stitt L, Donner A, Vermeire S, Van De Mierop FJ, Coche JR, van der Woude J, Ochsenkuhn T, van Bodegraven AA, Van Hootegem PP, Lambrecht GL, Mana F, Rutgeerts P, Feagan BG, Hommes D; Belgian Inflammatory Bowel Disease Research Group; North-Holland Gut Club. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet. 2008 Feb 23;371(9613):660-667. doi: 10.1016/S0140-6736(08)60304-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
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	—