Clinical Trial: Imuran Dosing in Crohn's Disease Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multi-site Trial of Azathioprine Dosing in Crohn's Disease

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Current Primary Outcome: Proportion of subjects achieving clinical remission at week #16.

Original Primary Outcome:

  • The primary outcome measure will be the proportion of subjects achieving clinical remission at week #16.
  • For the steroid-dependent subjects, clinical remission is defined as complete withdrawal of corticosteroids, and Crohn's Disease Activity Index (CDAI) score <150 in adults, or modified CDAI (mCDAI) score <150 in children.
  • For the steroid-refractory subjects, clinical remission is defined as CDAI score <150 (or mCDAI <150 in children), and a reduction of at least 70 points from the baseline score (CDAI or mCDAI), and complete withdrawal of corticosteroids.


Current Secondary Outcome: Proportion of subjects maintaining clinical remission at week #28 and #52

Original Secondary Outcome:

  • Proportion of subjects maintaining clinical remission at week #28
  • Proportion of subjects maintaining clinical remission at week #52
  • Frequency of any adverse events (AE): • Frequency of AEs requiring dose reduction. • Frequency of AEs requiring drug cessation.
  • Corticosteroid use in the two treatment arms.
  • Adult and pediatric health-related quality of life (HRQOL) index scores in the two treatment arms (Inflammatory Bowel Disease Questionnaire (IBDQ) in adults and IMPACT in children).
  • Levels of TPMT at 28 weeks compared to baseline to determine if TPMT activity is induced during therapy.


Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Dates:
Date Received: June 8, 2005
Date Started: February 2005
Date Completion: November 2007
Last Updated: January 12, 2010
Last Verified: January 2010