DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Dr. Falk Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Azathioprine (Drug); Mesalazine (Drug); Azathioprine placebo (Drug); Mesalazine placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dr. Falk Pharma GmbH

Official(s) and/or principal investigator(s):
Walter Reinisch, Prof, Principal Investigator, Affiliation: Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie, Vienna, Austria

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome:

endoscopic improvement at month 12, defined as ≥1 point reduction in Rutgeerts' score.

change in CDAI score

adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie, Vienna 1090, Austria

Robert-Bosch Krankenhaus, Innere Medizin I, Stuttgart Postfach 501120, Germany

Additional Information

Starting date: February 2002
Last updated: June 25, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017