Top Down Versus Step Up Strategies in Crohn's Disease
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, immunomodulators, biologicals
Eligibility 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
Sites / Locations
- Imelda GI Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
Patients received three infusions of infliximab 5 milligrams per kilogram (weeks 0, 2 and 6) in combination with azathioprine 2-2.5 milligrams per kilogram per day from day 0 onwards. If the patients responded and tolerated both drugs, azathioprine was continued for the duration of the trial. Patients who were intolerant to azathioprine received methotrexate at an initial dose of 25 milligrams administered subcutaneously each week for 12 weeks with dose reduction to 15 milligrams per week thereafter. Following initial therapy, patients who developed worsening symptoms were retreated with additional infusions of infliximab. If symptoms persisted methylprednisolone was initiated and azathioprine or methotrexate was continued.
Induction with methylprednisolone (MP) or budesonide (BUD): MP 32 mg/day for 3 weeks was followed by tapering by 4 mg per week to 0; BUD 9 mg per day for 8 weeks with tapering to 0 by 3 mg per week thereafter.Patients who worsened during the tapering had the dose increased to the initial dose and tapered again. If patients worsened, azathioprine (2-2.5 mg per day) was introduced. Patients who relapsed following withdrawal of steroids received a second course in combination with azathioprine. For patients who failed 4 weeks of steroids, MP dose was given at 64 mg/day for 2 weeks, tapered by 8 mg per week; azathioprine was added. Patients who remained symptomatic despite 16 weeks of azathioprine received infliximab (5 mg/kg IV at weeks 0, 2 and 6). Patients who relapsed despite methotrexate or those intolerant to both azathioprine and methotrexate also received infliximab, without antimetabolite therapy. Infliximab was repeated upon relapse of symptoms in these patients.