Crohn's Disease
Conditions
Keywords
Crohn's disease, immunomodulators, biologicals
Brief 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.
Interventions
DRUGinfliximab+azathioprine
infliximab 5 mg/kg at week 0,2 and 6 + azathioprine 2-2.5 mg/kg
DRUGmethylprednisolone or budesonide
methylprednisolone 32 mg followed by taper or budesonide 9 mg/day followed by taper
Sponsors
Centocor BV
Schering-Plough
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission without corticosteroids and without surgical resection | month 6 and 12 after inclusion |
Secondary
| Measure | Time frame |
|---|---|
| the time to relapse after successful induction therapy | within 24 months |
| the proportion of patients receiving infliximab, methylprednisolone and antimetabolites | within 24 months |
| the median serum C-reactive protein concentration | 24 months |
| the proportion of patients experiencing adverse events | 24 months |
| the mean endoscopic severity scores and the proportion of patients without ulcers | after 24 months |
Countries
Belgium
Outcome results
None listed