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Trial registered on ANZCTR


Registration number
ACTRN12605000429651
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
16/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
COMBINATION ANTI-PARATUBERCULOSIS THERAPY WITH RIFABUTIN, CLARITHROMYCIN AND CLOFAZIMINE FOR CROHNâ¿¿S DISEASE: A THREE YEAR PROSPECTIVE, RANDOMISED, PLACEBO-CONTROLLED, MULTICENTRE STUDY
Scientific title
COMBINATION ANTI-PARATUBERCULOSIS THERAPY WITH RIFABUTIN, CLARITHROMYCIN AND CLOFAZIMINE FOR CROHNâ¿¿S DISEASE: A THREE YEAR PROSPECTIVE, RANDOMISED, PLACEBO-CONTROLLED, MULTICENTRE STUDY
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 539 0
Condition category
Condition code
Oral and Gastrointestinal 618 618 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two year's treatment with rifabutin, clarithromycin and clofazamine.
Intervention code [1] 534 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 723 0
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
Timepoint [1] 723 0
At 12, 24 and 36 months
Secondary outcome [1] 1484 0
To compare the safety profile of the antibiotic combination and placebo study arms.
Timepoint [1] 1484 0
Secondary outcome [2] 1485 0
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.
Timepoint [2] 1485 0
Secondary outcome [3] 1486 0
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.
Timepoint [3] 1486 0
Secondary outcome [4] 1487 0
To determine whether the time to first relapse was different between the two treatment groups.
Timepoint [4] 1487 0
Secondary outcome [5] 1488 0
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.
Timepoint [5] 1488 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
computer generated codes kept in sealed envelopes held in a secure location by an independent staff member
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated codes stratified by study centre and by concurrent immunomodulator therapy
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
double blind, placebo control, parallel to assess efficacy of antibiotic therapy against Mycobacterium paratuberculosis in Crohn's disease
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 676 0
Commercial sector/Industry
Name [1] 676 0
Pfizer Australia
Address [1] 676 0
Country [1] 676 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pfizer Australia
Address
Country
Australia
Secondary sponsor category [1] 565 0
None
Name [1] 565 0
nil
Address [1] 565 0
Country [1] 565 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
An investigation of the effect of three antibiotics directed against Mycobacterium paratuberculosis, the cause of Johne's disease in sheep and cattle, in patients with active Crohn's disease
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36004 0
Address 36004 0
Country 36004 0
Phone 36004 0
Fax 36004 0
Email 36004 0
Contact person for public queries
Name 9723 0
Associate Professor Brendan Crotty
Address 9723 0
Austin Health/Northern Health Clinical School
PO Box 5555
Heidelberg VIC 3084
Country 9723 0
Australia
Phone 9723 0
+61 3 94965585
Fax 9723 0
+61 3 94575768
Email 9723 0
b.crotty@unimelb.edu.au
Contact person for scientific queries
Name 651 0
Associate Professor Brendan Crotty
Address 651 0
Austin Health/Northern Health Clinical School
PO Box 5555
Heidelberg VIC 3084
Country 651 0
Australia
Phone 651 0
+61 3 94965585
Fax 651 0
+61 3 94575768
Email 651 0
b.crotty@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary