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

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ClinicalTrials.gov Identifier: NCT01150890
Recruitment Status : Terminated (Per recommendation from DRT)
First Posted : June 25, 2010
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 130 participants
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
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. To evaluate improvement from baseline in CDAI at week 6 [ Time Frame: 6 Weeks ]
  3. To evaluate the short term safety profile of AMG 827 in subjects with Crohn's disease [ Time Frame: 12 Weeks ]
  4. To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Crohn's disease [ Time Frame: 6 Weeks ]


Information from the National Library of Medicine

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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

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


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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01150890     History of Changes
Other Study ID Numbers: 20090072
First Posted: June 25, 2010    Key Record Dates
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