stop_circleTerminated/Withdrawn

Crohn’s disease

Bayer Identifier:

20090072

ClinicalTrials.gov Identifier:

NCT01150890

EudraCT Number:

Not Available

EU CT Number:

Not Available
AMG 827 in Subjects with Moderate to Severe Crohn’s Disease

Trial purpose

The study will examine the safety and effectiveness of AMG 827 for the treatment of moderate to severe Crohn’s disease. Patients will randomly receive either AMG 827 or placebo (a lookalike liquid that doesn’t have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • -Diagnosed with ileal, ileo-colonic, or colonic Crohn’s disease for a minimum of 6 months prior to initiating Study Product
    -Moderately to severely active Crohn’s disease, as defined by a CDAI score >250 and <450 at baseline
    -Evidence of active inflammation
  • - Short bowel syndrome
    - Stricture with obstructive symptoms within 3 months
    - Bowel surgery within 3 months
    - Ileostomy and/or colostomy
    - Any gastric or intestinal pouch
    - Ulcerative colitis
    - Evidence of an infected abscess
    - Bowel perforation or evidence of noninflammatory obstruction during the 6 months Stool positive for C. Difficile toxin at screening
    - Presence of active infection requiring treatment
    - Serious infection within 8 weeks
    - Significant concurrent medical conditions
    - Pregnant or breast feeding
    - Significant Laboratory abnormalities
    - Any anti-TNF agent within 2 months
    - Steroid enemas within 2 weeks
    - Tysabri (natalizumab) within 1 year
    - Biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months
    - Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months

Trial summary

Enrollment Goal
130
Trial Dates
July 2010 - August 2011
Phase
Phase 2
Could I Receive a placebo
Yes
Products
N/A
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Research SitePontevedra, Spain
Recruiting
Research SiteSantiago de Compostela, Spain
Recruiting
Research SiteMadrid, Spain
Recruiting
Research SiteBirmingham, United States
Recruiting
Research SiteDithan, United States
Recruiting
Research SiteLowell, United States
Recruiting
Research SiteMiami, United States
Recruiting
Research SiteMiami, United States
Recruiting
Research SiteJacksonville, United States
Recruiting
Research SiteHammond, United States
Recruiting
Research SiteChevy Chase, United States
Recruiting
Research SiteRochester, United States
Recruiting
Research SiteMexico, United States
Recruiting
Research SiteEgg Harbor Township, United States
Recruiting
Research SiteGreat Neck, United States
Recruiting
Research SiteCharlotte, United States
Recruiting
Research SiteWilmington, United States
Recruiting
Research SiteNashville, United States
Recruiting
Research SiteGermantown, United States
Recruiting
Research SiteSan Antonio, United States
Recruiting
Research SiteLogan, United States
Recruiting
Research SiteOgden, United States
Recruiting
Research SiteCalgary, Canada
Recruiting
Research SiteVancouver, Canada
Recruiting
Research SiteVictoria, Canada
Recruiting
Research SiteWinnipeg, Canada
Recruiting
Research SiteToronto, Canada
Recruiting
Research SiteHamilton, Canada
Recruiting
Research SiteLondon, Canada
Recruiting
Research SiteMontreal, Canada
Recruiting
Research SiteKurralta Park, Australia
Recruiting
Research SiteBarcelona, Spain
Recruiting
Research SiteParis Cedex 10, France
Recruiting
Research SiteBox Hill, Australia
Recruiting
Research SiteVandoeuvre les Nancy, France
Recruiting
Research SiteFitzroy, Australia
Recruiting
Research SiteParis, France
Recruiting
Research SiteToulouse Cedex 09, France
Recruiting
Research SiteNice Cedex 3, France
Recruiting
Research SiteMaastricht, Netherlands
Recruiting
Research SiteBonheiden, Belgium
Recruiting
Research SiteGent, Belgium
Recruiting
Research SiteLille cedex, France
Recruiting
Research SiteRoeselare, Belgium
Recruiting
Research SiteLeuven, Belgium
Recruiting
Research SiteFremantle, Australia
Recruiting
Research SiteSopot, Poland
Recruiting
Research SiteRotterdam, Netherlands
Recruiting
Research SiteBydgoszcz, Poland
Recruiting
Research SiteOlsztyn, Poland
Recruiting
Research SiteAmsterdam, Netherlands
Recruiting
Research SiteBarcelona, Spain
Recruiting
Research SiteOpole, Poland

Primary Outcome

  • To evaluate the efficacy of AMG 827 compared with placebo as measured by the proportion of subjects achieving Crohn’s Disease Activity Index (CDAI) remission (≤ 150) at week 6.
    date_rangeTime Frame:
    6 Weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • To evaluate the efficacy of AMG 827 as measured by the proportion of subjects with a CDAI response (reduction from baseline of ≥ 100) at week 6
    date_rangeTime Frame:
    6 Weeks
    enhanced_encryption
    Safety Issue:
    no
  • To evaluate improvement from baseline in CDAI at week 6
    date_rangeTime Frame:
    6 Weeks
    enhanced_encryption
    Safety Issue:
    no
  • To evaluate the short term safety profile of AMG 827 in subjects with Crohn’s disease
    date_rangeTime Frame:
    12 Weeks
    enhanced_encryption
    Safety Issue:
    yes
  • To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Crohn’s disease
    date_rangeTime Frame:
    6 Weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

AmgenTrials clinical trials website