Top Down Versus Step Up Strategies in Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554710
• Other study ID #: P01872
• Status: Completed
• Phase: Phase 4
• First received: November 6, 2007
• Last updated: November 6, 2007
• Start date: May 2001
• Est. completion date: January 2004

Study information

• Verified date: November 2007
• Source: Belgian IBD Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• infliximab+azathioprine
infliximab 5 mg/kg at week 0,2 and 6 + azathioprine 2-2.5 mg/kg
• methylprednisolone or budesonide
methylprednisolone 32 mg followed by taper or budesonide 9 mg/day followed by taper

Locations

Country	Name	City	State
Belgium	Imelda GI Clinical Research Center	Bonheiden

Sponsors (3)

Lead Sponsor	Collaborator
Belgian IBD Research Group	Centocor BV, Schering-Plough

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	remission without corticosteroids and without surgical resection		month 6 and 12 after inclusion
Secondary	the time to relapse after successful induction therapy		within 24 months
Secondary	the proportion of patients receiving infliximab, methylprednisolone and antimetabolites		within 24 months
Secondary	the median serum C-reactive protein concentration		24 months
Secondary	the proportion of patients experiencing adverse events		24 months
Secondary	the mean endoscopic severity scores and the proportion of patients without ulcers		after 24 months