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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier:
NCT00946946
First received: July 24, 2009
Last updated: June 25, 2012
Last verified: June 2012

July 24, 2009
June 25, 2012
February 2002
May 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00946946 on ClinicalTrials.gov Archive Site
  • endoscopic improvement at month 12, defined as ≥1 point reduction in Rutgeerts' score. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • change in CDAI score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Preventing Postoperative Relapse in Crohn's Disease Patients at Risk: Azathioprine Versus Mesalazine
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Crohn's Disease
  • Drug: Azathioprine
    2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets
    Other Name: Azafalk 50mg tablets
  • Drug: Mesalazine
    4g Mesalazine tablets/day AND azathioprine placebo tablets
    Other Name: Salofalk 500mg tablets
  • Drug: Azathioprine placebo
    4g Mesalazine tablets/day AND azathioprine placebo tablets
  • Drug: Mesalazine placebo
    2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets
  • Experimental: Azathioprine
    2.0-2.5 mg/kg/BW azathioprine tablets/day AND mesalazine placebo tablets
    Interventions:
    • Drug: Azathioprine
    • Drug: Mesalazine placebo
  • Active Comparator: Mesalazine
    4g mesalazine tablets/day AND azathioprine placebo tablets
    Interventions:
    • Drug: Mesalazine
    • Drug: Azathioprine placebo
Reinisch W, Angelberger S, Petritsch W, Shonova O, Lukas M, Bar-Meir S, Teml A, Schaeffeler E, Schwab M, Dilger K, Greinwald R, Mueller R, Stange EF, Herrlinger KR; International AZT-2 Study Group. Azathioprine versus mesalazine for prevention of postoperative clinical recurrence in patients with Crohn's disease with endoscopic recurrence: efficacy and safety results of a randomised, double-blind, double-dummy, multicentre trial. Gut. 2010 Jun;59(6):752-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
July 2009
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Austria
 
NCT00946946
AZT-2/CDP
No
Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH
Not Provided
Principal Investigator: Walter Reinisch, Prof Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie, Vienna, Austria
Dr. Falk Pharma GmbH
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP