Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine
Phase 3
Completed
- Conditions
- Crohn's Disease
- Interventions
- Registration Number
- NCT00946946
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azathioprine Mesalazine placebo 2.0-2.5 mg/kg/BW azathioprine tablets/day AND mesalazine placebo tablets Mesalazine Mesalazine 4g mesalazine tablets/day AND azathioprine placebo tablets Mesalazine Azathioprine placebo 4g mesalazine tablets/day AND azathioprine placebo tablets Azathioprine Azathioprine 2.0-2.5 mg/kg/BW azathioprine tablets/day AND mesalazine placebo tablets
- Primary Outcome Measures
Name Time Method 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. 12 months
- Secondary Outcome Measures
Name Time Method endoscopic improvement at month 12, defined as ≥1 point reduction in Rutgeerts' score. 12 months change in CDAI score 12 months adverse events 12 months
Trial Locations
- Locations (2)
Robert-Bosch Krankenhaus, Innere Medizin I
🇩🇪Stuttgart, Germany
Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie
🇦🇹Vienna, Austria