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AMG 827 in Subjects With Moderate to Severe Crohn's Disease

This study has been terminated.
(Per recommendation from DRT)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01150890
First Posted: June 25, 2010
Last Update Posted: January 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  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.

Condition Intervention Phase
Crohn's Disease Drug: AMG 827 350 MG Drug: AMG 827 210 MG Drug: AMG 827 700 MG Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 Weeks ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 Weeks ]
  • To evaluate improvement from baseline in CDAI at week 6 [ Time Frame: 6 Weeks ]
  • To evaluate the short term safety profile of AMG 827 in subjects with Crohn's disease [ Time Frame: 12 Weeks ]
  • To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Crohn's disease [ Time Frame: 6 Weeks ]

Enrollment: 130
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 827 IV 350 MG
350 mg AMG 827
Drug: AMG 827 350 MG
350 mg AMG 827 IV (in the vein)
Experimental: AMG 827 IV 700 MG
700 mg AMG 827
Drug: AMG 827 700 MG
700 mg AMG 827 IV (in the vein)
Placebo Comparator: PLACEBO
Placebo
Drug: Placebo
Placebo IV (in the vein)
Experimental: AMG 827 IV 210 MG
210 mg AMG 827
Drug: AMG 827 210 MG
210 mg AMG 827 IV (in the vein)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150890


  Show 51 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01150890     History of Changes
Other Study ID Numbers: 20090072
First Submitted: June 24, 2010
First Posted: June 25, 2010
Last Update Posted: January 14, 2016
Last Verified: December 2015

Keywords provided by Amgen:
Ileal Crohn's Disease
Ileo-colonic Crohn's Disease
Colonic Chron's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases