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Sponsors and Collaborators: |
Belgian IBD Research Group Centocor BV Schering-Plough |
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Information provided by: | Belgian IBD Research Group |
ClinicalTrials.gov Identifier: | NCT00554710 |
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.
Condition | Intervention | Phase |
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Crohn's Disease |
Drug: infliximab+azathioprine Drug: methylprednisolone or budesonide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the Benelux |
Enrollment: | 129 |
Study Start Date: | May 2001 |
Study Completion Date: | January 2004 |
Arms | Assigned Interventions |
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1: Experimental
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.
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Drug: infliximab+azathioprine
infliximab 5 mg/kg at week 0,2 and 6 + azathioprine 2-2.5 mg/kg
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2: Active Comparator
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.
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Drug: methylprednisolone or budesonide
methylprednisolone 32 mg followed by taper or budesonide 9 mg/day followed by taper
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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.
Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Imelda GI Clinical Research Center | |
Bonheiden, Belgium, 2820 |
Principal Investigator: | Geert R DHaens, MD, PhD | Belgian IBD Research Group |
Study ID Numbers: | P01872 |
Study First Received: | November 6, 2007 |
Last Updated: | November 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00554710 |
Health Authority: | Belgium: Institutional Review Board |
Crohn's disease immunomodulators biologicals |
Gastrointestinal Diseases Infliximab Methylprednisolone Budesonide Inflammatory Bowel Diseases Methylprednisolone acetate Prednisolone acetate |
Intestinal Diseases Digestive System Diseases Azathioprine Crohn Disease Prednisolone Gastroenteritis Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Antimetabolites Respiratory System Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Neuroprotective Agents Hormones Therapeutic Uses |
Dermatologic Agents Antineoplastic Agents, Hormonal Gastrointestinal Agents Anti-Asthmatic Agents Immunosuppressive Agents Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Bronchodilator Agents |