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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Prometheus Laboratories |
Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00113503 |
This study will compare two different dosing methods of azathioprine (IMURAN) in participants with Crohn's disease who are currently taking steroids (e.g. prednisone or budesonide)or who have just started steroids. The study can be up to 54 weeks long. All participants enrolled will receive active drug. Participants will take doses either based upon weight or based on the patient's ability to breakdown the drug (monitored by 6-thioguanine nucleotides (6-TGN) metabolite levels in the blood). All patients enrolled in the study will receive active study drug.
Condition | Intervention | Phase |
Crohn's Disease |
Drug: IMURAN (azathioprine) |
Phase II |
Genetics Home Reference related topics: | Crohn disease |
MedlinePlus related topics: | Crohn's Disease |
ChemIDplus related topics: | Azathioprine Azathioprine sodium salt |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Site Trial of Azathioprine Dosing in Crohn's Disease |
Estimated Enrollment: | 226 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | November 2007 |
This multi-center, double blind (patients and doctors do not know treatment group assignment), randomized (patients are put in 1 of 2 groups) clinical trial which will compare two 52-week-long azathioprine(AZA) dosing methods.
The patients enrolled will all be taking steroids (prednisone or budesonide)or have just been prescribed a steroid. The patients will be either in remission on steroids, but cannot taper off without a flare, patients who are on steroids and are still having Crohn's symptoms, or patients who need to start taking steroids.
After a two week screening period, patients fitting enrollment criteria will be begin taking study drug. Patients will begin to taper steroids per a set schedule, and taper off steroids completely by week 13. Patients who need to go back on steroids because of returned symptoms are allowed to, per a set schedule in the protocol. Patients will have monthly visits that include physical exams, blood tests and a quality of life questionnaire. Patients will be required to keep a diary of abdominal pain, liquid or soft stools and general well being.
After 6 months, only patients in remission (patients not on steroids, and not having active symptoms) will be allowed to continue for last 6 months of the study. Study visits during the last 6 months will be every 2 months, and include physical exams and blood tests, and a quality of life questionnaire.
Patients in the study may receive dose changes, and this will require additional blood tests for safety.
Ages Eligible for Study: | 10 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have steroid-dependent, steroid-refractory or steroid naive CD.
Steroid-naïve CD: currently moderately active CD, (CDAI or mCDAI 200 - 450) and one of the following:
Patients who have started steroids up to 14 days prior to screening will also qualify as steroid naïve, however patient needs to be on 40 mg prednisone or 9 mg budesonide.
Exclusion Criteria:
Treatment 2 weeks before screening:
United States, California | |||||
Cedars-Sinai Medical Center | |||||
Los Angeles, California, United States, 90048 | |||||
United States, Georgia | |||||
Atlanta Gastroenterology Associates, LLC | |||||
Atlanta, Georgia, United States, 30342 | |||||
United States, Illinois | |||||
University of Chicago | |||||
Chicago, Illinois, United States, 60637 | |||||
University of Chicago Pediatric Gastroenterology | |||||
Chicago, Illinois, United States, 60637 | |||||
United States, Maryland | |||||
Johns Hopkins University | |||||
Baltimore, Maryland, United States, 21287 | |||||
United States, Minnesota | |||||
Mayo Clinic | |||||
Rochester, Minnesota, United States, 55905 | |||||
Duluth Clinic | |||||
Duluth, Minnesota, United States, 55805 | |||||
United States, New York | |||||
Mt. Sinai Medical Center | |||||
New York, New York, United States, 10029 | |||||
Long Island Clinical Research Assoc. | |||||
Great Neck, New York, United States, 11021 | |||||
United States, North Carolina | |||||
University of North Carolina Chapel Hill | |||||
Chapel Hill, North Carolina, United States, 27514 | |||||
United States, Ohio | |||||
Cincinnati Children's Hospital | |||||
Cincinnati, Ohio, United States, 45229 | |||||
United States, Pennsylvania | |||||
University of Pittsburgh | |||||
Pittsburgh, Pennsylvania, United States, 15213 | |||||
Canada, Alberta | |||||
University of Alberta | |||||
Edmonton, Alberta, Canada, T6G2X8 | |||||
Canada, Ontario | |||||
London Health Sciences Centre | |||||
London, Ontario, Canada, N6A5A5 | |||||
Hospital for Sick Children | |||||
Toronto, Ontario, Canada, M5G 1X8 |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Prometheus Laboratories |
Principal Investigator: | Stephen B Hanauer, MD | University of Chicago |
Study ID Numbers: | DK60083, U01Dk60083 |
First Received: | June 8, 2005 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00113503 |
Health Authority: | United States: Food and Drug Administration |
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