The ideal management of Crohn's disease: top-down versus step-up strategies - a prospective controlled trial in the Benelux

Academic Medical Centre (AMC) (The Netherlands)0 个研究点目标入组 130 人开始时间: 2005年12月19日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Men and women aged 16 - 75 years
•2. New diagnosis of Crohn's disease (CD), endoscopically and histologically or radiologically (in the case of small bowel disease) proven or diagnosis of Crohn's disease in the previous 4 years but never treated with corticosteroids/budesonide or immunomodulators (azathioprine/6-mercaptopurine/methotrexate/cyclosporin/tacrolimus [FK 506]/mycophenolate mofetil) or biologics (Remicade® or any other investigational drugs)
•3. Clinical Disease Activity Index (CDAI) greater than 200 for more than four weeks (to exclude self-limited problems) in new patients or greater than 200 for more than two weeks for patients with known CD
•4. Symptoms do not improve with 5-aminosalicylic acid (5-ASA) therapy in appropriate doses (Pentasa® 4 g per day for 6 weeks) or are considered too serious to be treated with 5-ASA alone. Antibiotics can be given at the discretion of the investigator.
•5. Willing to sign the informed consent form
•6. Ability to comply with study visits and other protocol requirements
•7. Women of childbearing potential must be willing to use adequate birth control measures in the 6 month period following each infliximab infusion. If pregnant, they will be excluded from further infliximab infusions.

•1. Need for surgery at diagnosis or in the immediate future: complications such as abdominal abscess or stricture with obstruction
•2. Current signs or symptoms of severe, uncontrolled or progressive renal, hepatic, haematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
•3. Serious infections such as viral hepatitis, pneumonia, pyelonephritis in the last 3 months
•4. Recent or ongoing tuberculosis (less than 2 years) or treatment for tuberculosis
•5. Less serious infections should be treated appropriately, after which the patient can be included upon the discretion of the investigator
•6. Use of biologics, corticosteroids or immunemodulators for other diseases
•7. Documented human immunodeficiency virus (HIV) infection
•8. Any currently known malignancy or premalignant lesion or any history of malignancy in the last 5 years
•Active pregnancy or immediate pregnancy wish; pregnancy should be deferred until at least 6 months after the last infliximab infusion
•9. Patient on azathioprine have to continue this medication should they become pregnant during the study
•10. Allergy to murine proteins
•11. Known recent substance abuse (drugs or alcohol)
•12. Symptomatic stenosis or ileal/colonic strictures with prestenotic dilatation
•13. Positive stool culture for enteric pathogens

发起方

Academic Medical Centre (AMC) (The Netherlands)