"The Cause for a Cure for Crohn's Disease"
Treatment & diagnosis of Crohn's Disease
Phase III Clinical Trial of Anti-paratuberculosis Antibiotic Therapy Underway in Australia.
A phase III clinical trial of anti-paratuberculosis antibiotic therapy for Crohn's disease is ongoing in Australia. The antibiotic regimen under trial is a combination of Rifabutin (Mycobutin, Pharmacia), Clarithromycin (Biaxin/Klacid/Klaricid, Abbott Laboratories) and Clofazimine (Lamprene, Novartis). The Australian phase III trial involves over 200 patients with Crohn's disease, in all major cities across Australia. The purpose of the trial is to determine if anti-paratuberculosis antibiotic therapy is a more effective treatment for Crohn's disease than standard immunosuppressant therapy. This trial is a continuation of previous phase II trials which showed promising results using this and similar treatment regimes.
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About the trial
COMBINATION ANTI-PARATUBERCULOSIS THERAPY WITH RIFABUTIN, CLARITHROMYCIN AND CLOFAZIMINE IN THE TREATMENT OF ACTIVE CROHN'S DISEASE.
This clinical trial, ongoing at twenty hospitals throughout Australia, will test the theory that long-term combination antibiotic treatment may benefit people with Crohn's disease.
Gastroenterologists have been inviting volunteers with active Crohn's disease to participate in this important Australian-owned clinical trial since it began in September 1999. The 214th and last subject was entered on 21st September 2001.
Currently, 94 individuals are actively ongoing in the trial, half of whom are taking active antibiotic treatment, and half are taking placebo. 63 participants have been on the study beyond 1 year and 15
120 participants have withdrawn from the study thus far, the majority (35%) of whom did not meet the remission criteria at the 16 week interval. Some other reasons for withdrawal include side-effects (10%) and relapse/disease progression (29%).
An independent data monitoring committee (IDMC) has reviewed the interim study data on two separate occasions and recommended unanimously the continuation of the study in the current form.
An interim update on the study was presented at Asia Pacific Digestive Week in Sydney, September 2001, and the abstract by Selby, W. et al is published in The Journal of Gastroenterology and Hepatology (2001, 16 (Suppl), A8.
Objectives of the trial
The Primary objective of the trial is
The Secondary objectives of the trial are
Clinical Trial Design
The design of the Australian phase III clinical trial is as follows
Health Economics and Health-related Quality of Life
Crohn's disease is well known to have a significant impact on the quality of life of patients. This can often be exacerbated by the wide range of side-effects of standard treatments for Crohn's disease.
In order to the determine the effect on health and on quality of life of anti-paratuberculosis antibiotic treatment, patients taking part in the trial will fill out two forms every three months. The first form is designed to measure the patients general state of health, and will record information such as the patient's perception of their general state of health, ability to partake in physical activity, social and work activity, etc.
The second form is specific to Inflammatory Bowel Disease, and will record information relating to the effect of bowel problems on emotional state, social activity, sexual activity, lifestyle, etc.
Additionally, a goal of this clinical trial is to determine if anti-paratuberculosis antibiotic therapy is more cost-effective than existing treatments.
Previous Phase II Clinical Trials
The Australian phase III clinical trial is a continuation from previous phase II trials:
For a comprehensive listing of MAP Research Abstracts and Full-Text Articles, please visit the Scientific Articles area of our website.
Source: http://www.crohns.org/treatment/austrial.htm Contact PARA: http://www.crohns.org/contact.htm
Paratuberculosis Awareness & Research Association, 1999-2003.
Chiodini: Antimicrobial Agents and Crohn's disease: Do they have a therapeutic role?
List of MAP research papers