preventing postoperative relapse in crohn's disease patients at risk: azathioprine versus mesalazine

Conditions: Crohn's Disease

Summary: this study aims to compare azathioprine versus mesalazine tablets for the prevention of clinical relapse in postoperative crohn's disease (cd) patients with moderate or severe endoscopic recurrence.


Eligibility 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.

Keywords: randomized crohn's disease prevention azathioprine mesalazine mesalamine tpmt