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Crohn's DiseasePhase 2NCT00113503

Imuran Dosing in Crohn's Disease Study

A Phase 2 study testing Azathioprine weight-based dose and Azathioprine individualised dose in people with Crohn's Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 15 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 70 years
Conditions the study is for
Crohn's Disease
What is being tested?
Azathioprine weight-based dose and Azathioprine individualised dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
15 sitesin 2 countries
Study dates
Jul 2005to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 10-70 years-old., Weigh 20-100 kg (44-220 lbs).
  • CD of the ileum, colon or ileocolon, verified by colonoscopy, barium enema, or small bowel series performed within 36 months
  • Perianal fistulae will be eligible provided that the perianal disease does not account for the preponderance of symptoms.
  • Have steroid-dependent, steroid-refractory or steroid naive CD.
  • Steroid-dependent CD: CDAI or mCDAI of < 150 while receiving prednisone 10-40 mg/day or budesonide 3-9 mg/day for at least 12 weeks prior to screening, but unable to taper prednisone below 10 mg/day or budesonide below 3 mg/day without experiencing a flare within the previous 6 months. Steroids must be at a stable dose for 2 weeks prior to screening (week #-2), prednisone at a dose of 10-40 mg/day and budesonide at a dose of 3-9 mg/day.
  • Steroid-refractory CD: currently moderately active CD (CDAI or mCDAI 200 - 450) despite treatment with 40 kg) or 0.5 mg/kg/day (if weighing 20 mg/day (if weighing prednisone <40 9 mg/day for the previous 4 weeks prior to the screening kg), or budesonide evaluation. Prednisone or budesonide must be at a stable dose for 2 weeks prior to screening (week #-2).
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  • Steroid-naïve CD: currently moderately active CD, (CDAI or mCDAI 200 - 450) and one of the following:
  • Despite treatment with aminosalicylates and/or antibiotics for the previous 4 weeks prior to the screening evaluation, who are candidates for prednisone or budesonide.
  • Not currently on therapy, who are candidates for prednisone or budesonide
  • Patients with prior exposure to steroids, who have not been treated with steroids for 4 weeks prior to screening, and are candidates for prednisone or budesonide Prednisone or budesonide will be started at the screening visit, at a dose of 40 mg/day or 9 mg/day and tapered per the steroid taper.
  • 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.
  • Discontinue oral or rectal 5-Aminosalicylic acid (5-ASA) therapies, rectal steroids, ciprofloxacin or metronidazole at the screening visit.

Who cannot join

  • CDAI > 450
  • CD requiring hospitalization and intravenous (iv) corticosteroids, iv antibiotics or total parenteral nutrition (TPN).
  • TPN or enteral nutrition of >1000 Calories/day (both TPN and elemental diets impact the CDAI).
  • History of resection of more than 100 cm of small bowel, total proctocolectomy, or subtotal colectomy with ileorectal anastomosis
  • Ileostomy or colostomy
  • Severe fixed symptomatic stenosis of the small or large intestine
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  • Blood transfusion within 3 months before screening
  • Treatment with 6-MP or AZA within the 6 months prior to screening
  • Immunosuppressants or biologics 3 months before screening
  • Treatment 2 weeks before screening:
  • Allopurinol;
  • Trimethoprim-sulfamethoxazole;
  • NSAIDs or aspirin >81mg/day;
  • Cholestyramine or other drugs interfering with enterohepatic circulation;
  • Furosemide and thiazide diuretics;
  • Fish-oil preparations.
  • Discontinue use at screening: Oral or rectal 5-ASA, rectal steroids, metronidazole or quinolones
  • Any prior treatment with natalizumab
  • Presence of abnormal laboratory parameters:
  • Carriage of hepatitis B surface antigen or positive hepatitis C antibody
  • Lack of one acceptable form of contraception while receiving AZA
  • Low TPMT activity

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States12 sites

  • Atlanta Gastroenterology Associates, LLC

    Atlanta, Georgia, 30342

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27514

  • University of Chicago Pediatric Gastroenterology

    Chicago, Illinois, 60637

  • University of Chicago

    Chicago, Illinois, 60637

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

  • Duluth Clinic

    Duluth, Minnesota, 55805

  • Long Island Clinical Research Assoc.

    Great Neck, New York, 11021

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Canada3 sites

  • University of Alberta

    Edmonton, Alberta, T6G2X8

  • London Health Sciences Centre

    London, Ontario, N6A5A5

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

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

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.

Read the detailed description

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.

Conditions
Crohn's Disease
Being tested
Azathioprine weight-based dose, Azathioprine individualised dose
Keywords
Inflammatory Bowel Disease, Crohn's disease, Crohn's Colitis
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Azathioprine weight-based doseDrug

    Also called Imuran

  • Azathioprine individualised doseDrug

    Also called Imuran

Study groups in NCT00113503
Study groupRoleWhat they receive
Azathioprine weight-based doseActive comparatorNot described
Receives: Drug: Azathioprine weight-based dose
Azathioprine individualised doseExperimentalNot described
Receives: Drug: Azathioprine individualised dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects achieving clinical remission at week #16.

    For the steroid-dependent subjects, clinical remission was 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 and the steroid-naıve subjects, clinical remission was 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.

    Measured: 16 weeks

Secondary outcomes (2)

  1. Proportion of subjects maintaining clinical remission at week #28

    Measured: 28 weeks

  2. Proportion of subjects maintaining clinical remission at week #52

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Why it stopped: Insufficient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00113503
Sponsor's protocol ID
DK60083 (terminated)
Other IDs
U01DK060083
Status last verified
Oct 2017
First submitted
8 Jun 2005
Last updated
6 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Dassopoulos T, Dubinsky MC, Bentsen JL, Martin CF, Galanko JA, Seidman EG, Sandler RS, Hanauer SB. Randomised clinical trial: individualised vs. weight-based dosing of azathioprine in Crohn's disease. Aliment Pharmacol Ther. 2014 Jan;39(2):163-75. doi: 10.1111/apt.12555. Epub 2013 Nov 17.

    PubMed 24237037

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azathioprine weight-based dose and Azathioprine individualised dose in people with Crohn's Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects achieving clinical remission at week #16. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00113503, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.

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