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Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence.

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ClinicalTrials.gov Identifier: NCT02247258
Recruitment Status : Terminated (Slow recruitment)
First Posted : September 23, 2014
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
International organization for the study of inflammatory bowel disease (IOIBD)
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
The objective of this study is to evaluate if in the prevention of postoperative recurrence of ileal Crohn's disease immediate initiation of azathioprine postoperatively is superior to delayed (6- 12 mths.) introduction of azathioprine upon disease recurrence assessed by endoscopic criteria. The primary endpoint, disease recurrence, encompasses symptomatic and surgical recurrence as well as severe endoscopic lesions at the final, 2 year, assessment.

Condition or disease Intervention/treatment Phase
Crohn Disease Recurrence Azathioprine Prevention Drug: Azathioprine Drug: Azathioprine in case of endoscopic recurrence Procedure: Ileocolonoscopy Procedure: Small bowel follow trough Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence: Systematic Versus Endoscopic-directed Treatment. A Multi-center, Randomized, Clinical Practice Evaluation Study.
Study Start Date : October 2005
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2015

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Arm Intervention/treatment
Active Comparator: Systematic azathioprine group
Patients randomized to the systematic azathioprine group received 2.0-2.5 mg/kg azathioprine within 14 days from surgery and throughout 102 weeks.
Drug: Azathioprine
See arm/group descriptions

Procedure: Ileocolonoscopy
See arm/group descriptions

Procedure: Small bowel follow trough
See arm/group descriptions

Active Comparator: Endoscopy-driven azathioprine group
Patients randomized to the endoscopy-driven azathioprine group received no Crohn's disease specific treatment for 26 weeks postoperatively. A first ileocolonoscopy was performed at week 26. In case of endoscopic recurrence (Rutgeerts' score i2 or higher), azathioprine was introduced at a dose of 2.0-2.5 mg/kg until week 102. If not, an ileocolonoscopy was repeated at week 52, and azathioprine started in case of endoscopic recurrence. If no endoscopic recurrence was observed, no Crohn's disease-specific treatment was given until week 102.
Drug: Azathioprine in case of endoscopic recurrence
See arm/group descriptions

Procedure: Ileocolonoscopy
See arm/group descriptions

Procedure: Small bowel follow trough
See arm/group descriptions




Primary Outcome Measures :
  1. Endoscopic remission [ Time Frame: Week 102 ]
    The proportion of patients with endoscopic remission (Rutgeerts' postoperative endoscopic score i0 or i1) at 102 weeks


Secondary Outcome Measures :
  1. Complete endoscopic remission [ Time Frame: Week 102 ]
    The percentage of patients with a Rutgeerts' score of i0 at 102 weeks

  2. Absence of endoscopic relapse [ Time Frame: Week 102 ]
    The percentage of patients with a Rutgeerts' score of i0-i2 at 102 weeks

  3. Clinical remission [ Time Frame: Week 102 ]
    The percentage of patients in clinical remission (Crohn's disease activity index, CDAI <150) at 102 weeks

  4. Sustained clinical remission [ Time Frame: Week 102 ]
    Crohn's disease activity index, CDAI < 150 throughout the 102 weeks study period

  5. Radiological remission [ Time Frame: Week 102 ]
    The percentage of patients with radiological remission at 102 weeks.



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Scheduled surgery for Crohn's disease (CD) with ileocolonic resection. Diagnosis of CD confirmed at least 4 months prior to surgery based on radiology and/or endoscopy.
  2. Having an increased risk for postoperative relapse for any of the following reasons: (1) active inflammatory disease with C-reactive protein level (CRP) elevated above 10 mg/L, or the use of antibiotics, steroids or biological therapy including infliximab for active ileal disease within 2 months before surgery which were administered for Crohn's disease and not for another unrelated intercurrent inflammatory or infectious disease; (2) perforating disease defined as the presence of entero-enteric or enterocutaneous fistulas or perivisceral abscess formation within 2 months before surgery. Perianal fistulizing disease will not be considered as an indication of perforating disease in the ileum or right-sided colon. (3) Previous ileo-colonic resection, (4) active smoking, (5) age below 30.
  3. Males and females 16-75 years old.
  4. Curative surgical resection. All macroscopically inflamed colonic segments (except for anorectal involvement) are to be removed at surgery. Stricturoplasties in small bowel segments not involving the anastomotic region are allowed.
  5. Patients able to start oral nutrition and oral therapy within 14 days from surgery.
  6. Patients able and willing to give written informed consent
  7. Women of childbearing potential should have a negative pregnancy test at inclusion.

Exclusion Criteria:

  1. Patients who only had strictureplasties or ileal/colonic resection without a new ileo-colonic anastomosis. Patients with ileorectal anastomosis.
  2. Patients with no increased risk of postoperative relapse as defined before.
  3. Patients with a known intolerance to azathioprine/6-mercaptopurine or with known homozygous thiopurine methyltransferase-low mutation.
  4. Patients in whom more than 100 cm of small bowel has been previously resected.
  5. Patients with active perianal disease or colorectal stenosis precluding ileocolonoscopy
  6. Patients with sepsis or other postoperative complications necessitating use of antibiotics for more than 14 days after surgery.
  7. Patients with liver test abnormalities (serum glutamate oxaloacetate transaminase, serum glutamate pyruvate transaminase, alkaline phosphatase, bilirubin > 2 ULN), leucopenia (<3000 white blood cell count /µL, <1500 neutrophils /µL), thrombopenia with < 50.000 platelets/mm3.
  8. Patients with severe renal, pulmonary or cardiac disease.
  9. Pregnant or lactating women.
  10. Ongoing alcohol or substance abuse.
  11. Ongoing or recent (within 6 months) infectious disease (viral hepatitis, tuberculosis, AIDS, Herpes zoster related disease).
  12. Known malignancy 5 years from surgery except for superficial epithelioma of the skin with curative resection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247258


Locations
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Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
UZ Leuven
Leuven, Belgium, 3000
Czech Republic
Univerzity Karlovy
Prague, Czech Republic
Greece
Evangelismos Hospital
Athens, Greece
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
International organization for the study of inflammatory bowel disease (IOIBD)
Investigators
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Principal Investigator: Gert Van Assche, MD PhD UZ Leuven

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02247258     History of Changes
Other Study ID Numbers: ML3121
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: September 2014
Additional relevant MeSH terms:
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Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Azathioprine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents