NCT00946946

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2002

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

5.2 years

First QC Date

July 24, 2009

Last Update Submit

June 25, 2012

Conditions

Crohn's Disease

Keywords

RandomizedCrohn's DiseasePreventionAzathioprinemesalazinemesalamineTPMT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

Azathioprine

EXPERIMENTAL

2.0-2.5 mg/kg/BW azathioprine tablets/day AND mesalazine placebo tablets

Drug: AzathioprineDrug: Mesalazine placebo

Mesalazine

ACTIVE COMPARATOR

4g mesalazine tablets/day AND azathioprine placebo tablets

Drug: MesalazineDrug: Azathioprine placebo

Interventions

AzathioprineDRUG

2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets

Also known as: Azafalk 50mg tablets
Azathioprine
MesalazineDRUG

4g Mesalazine tablets/day AND azathioprine placebo tablets

Also known as: Salofalk 500mg tablets
Mesalazine
Azathioprine placeboDRUG

4g Mesalazine tablets/day AND azathioprine placebo tablets

Mesalazine
Mesalazine placeboDRUG

2.0-2.5mg/kg/BW azathioprine /day and mesalazine placebo tablets

Azathioprine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Lesions confined to the ileocolonic anastomosis (i.e., \< 1 cm in length)
  • Short bowel syndrome,
  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitaetsklinik für Innere Medizin III, Abteilung Gastroenterologie and Hepatologie

Vienna, 1090, Austria

Location

Robert-Bosch Krankenhaus, Innere Medizin I

Stuttgart, Postfach 501120, Germany

Location

Related Publications (1)

  • 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. doi: 10.1136/gut.2009.194159.

    PMID: 20551460RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

AzathioprineMesalamine

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and Nucleosidesmeta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Walter Reinisch, Prof

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

February 1, 2002

Primary Completion

May 1, 2007

Study Completion

July 1, 2009

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

AU(1)DE(1)