COMBINATION ANTI-PARATUBERCULOSIS THERAPY WITH RIFABUTIN, CLARITHROMYCIN AND CLOFAZIMINE FOR CROHNâ¿¿S DISEASE: A THREE YEAR PROSPECTIVE, RANDOMISED, PLACEBO-CONTROLLED, MULTICENTRE STUDY

Pfizer Australia0 个研究点目标入组 212 人开始时间: 2005年9月16日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Crohn's disease diagnosed according to standard clinical, endoscopic, radiological and histological criteria were entered into the study. At entry, all had active disease, defined as Crohn's Disease Activity Index (CDAI) 200. Patients with isolated upper gastrointestinal or isolated perianal Crohn's disease or a stoma were not eligible for participation in the study. Patients requiring intravenous corticosteroids at the time of study entry and those thought likely to require surgery during the first four months of the study were also excluded. Other exclusion criteria included a stool examination positive for enteric pathogens, pathogenic ova or parasites, uncontrolled serious infection, and significant cardiovascular, respiratory, renal, hepatic, neurologic, psychiatric, endocrine or metabolic disease. Permitted medications included: corticosteroids at a dose of prednisone of 10 mg or less (or other steroids at an equivalent dosage) over the month prior to enrolment; azathioprine or 6-mercaptopurine at a stable dose for at least 6 months prior to enrolment and 5-aminosalicylates at a stable dose for at least four weeks prior to entry.

•The use of antibiotics for Crohn's disease within one month of entry was an exclusion criterion as were use of methotrexate, cyclosporine or drugs known to interact with rifabutin (e.g. anticoagulants) within three months of entry.

发起方

Pfizer Australia