Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00946946
• Date of registration: 24/07/2009
• Prospective Registration: No
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine
• Scientific title: Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence
• Date of first enrolment: February 2002
• Target sample size: 78
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00946946
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Austria, Germany

Contacts

• Name: Walter Reinisch, Prof
• Affiliation: Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie, Vienna, Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent,

- Man or woman between 18 and 70 years of age,

- Diagnosis of Crohn's disease confirmed by endoscopic and histological, or endoscopic
and radiological criteria within one year or by histopathological criteria during
resection,

- Clinical remission defined as Crohn´s Disease Activity Index (CDAI) < 200, within the
last two weeks. No clinical relapse due to Crohn's disease since resection,

- Moderate (i2a) or severe endoscopic recurrence (i3-i4) within 6 to 24 months after
curative resection of the terminal ileum and partial colectomy with ileocolonic
resection for complications of ileal Crohn´s disease and with a construction of an
ileocolonic anastomosis,

- Within the neoterminal ileum at least more than 5 aphthous lesions with normal mucosa
between the lesions, or skip areas of larger lesions,

- Negative pregnancy test at screening visit in females of childbearing potential,

- Use of appropriate contraceptive methods for females of childbearing potential and
males with procreative capacity during treatment and at least up to 3 months after
the end of treatment.

Exclusion Criteria:

- Lesions confined to the ileocolonic anastomosis (i.e., < 1 cm in length)

- Short bowel syndrome,

- Serious secondary illnesses of an acute or chronic nature, which in the opinion of
the Investigator renders the patient unsuitable for inclusion into the study,

- Serum creatinine levels exceeding 1.5 mg/dL or 130 umol/L,

- Presence of an ileo-/colonic stoma,

- Genotype: thiopurine methyltransferase (TPMT) -/-,

- Known previous or concurrent malignancy (other than that considered surgically cured,
with no evidence for recurrence for 5 years),

- Treatment with cytostatics or immunosuppressants, methotrexate, cyclosporine, 6-MP,
Azathioprine, 6-TG or anti-TFN-alpha therapy since resection; postoperative treatment
with corticosteroids for more than 4 weeks or postoperative treatment with oral
antibiotics (e.g., metronidazole, ciprofloxacin) for more than 4 weeks,

- Application of non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before
Screening visit except low dose acetylsalicylic acid and except paracetamol,

- Known intolerance/hypersensitivity to study drugs or drugs of similar chemical
structure or pharmacological profile,

- Scheduled or intended active immunisation with living vaccines within the next 12
months,

- Well-founded doubt about the patient's cooperation,

- Existing pregnancy, lactation, or intended pregnancy or impregnation within the next
15 months,

- Non-use of appropriate contraceptives in males with procreative capacity and females
of childbearing potential (e.g. condoms for males, intrauterine device [IUD],
hormonal contraception for females, or a means of contraception for a particular
patient considered adequate by the responsible investigator) during treatment and
within 3 months after the end of treatment,

- Participation in another clinical trial within the last 30 days, simultaneous
participation in another clinical trial, or previous participation in this trial,

- Present stricture plasty (no exclusion if the present stricture plasty was
macroscopically without any relevant finding of inflammation seen during index
surgery.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Azathioprine

Drug: Mesalazine placebo

Drug: Azathioprine placebo

Drug: Mesalazine

Primary Outcome(s)

The primary endpoint was therapeutic failure at one year, defined as CDAI score =200 and an increase of =60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction. [Time Frame: 12 months]

Secondary Outcome(s)

change in CDAI score [Time Frame: 12 months]

endoscopic improvement at month 12, defined as =1 point reduction in Rutgeerts' score. [Time Frame: 12 months]

adverse events [Time Frame: 12 months]

Secondary ID(s)

AZT-2/CDP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors