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

Completed

• Conditions: Crohn's disease; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12605000429651
• Lead Sponsor: Pfizer Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether the proportion (%) of patients who experienced at least one relapse of Crohn's disease at 12, 24 and 36 months was significantly different between those treated with rifabutin, clarithromycin and clofazamine for 24 months and those treated with placebo for 24 months[At 12, 24 and 36 months]

Secondary Outcome Measures

Name	Time	Method
To compare the safety profile of the antibiotic combination and placebo study arms.[];To determine whether the percentage of patients in remission was different after 16 weeks of antibiotic therapy added to standard corticosteroid therapy when compared to steroid therapy alone.[];To determine whether the number of relapses of Crohn's disease per subject within each study period (i.e. Weeks 16-52, Weeks 53-104 and Weeks 105-156) (for patients in remission at the beginning of the relevant period) differed between the two treatment groups.[];To determine whether the time to first relapse was different between the two treatment groups.[];To compare the clinical outcomes (including colonoscopic scores, need for Crohnâ¿¿s disease-related surgery, and changes in laboratory parameters [albumin, C-reactive protein and ESR]) between the two treatment groups for patients who were in remission at the beginning of the relevant study period.[]