stop_circleTerminated/Withdrawn
Crohn’s disease
Bayer Identifier:
20090072
ClinicalTrials.gov Identifier:
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
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
130Trial Dates
July 2010 - August 2011Phase
Phase 2Could I Receive a placebo
YesProducts
N/AAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Research Site | Pontevedra, Spain |
Recruiting | Research Site | Santiago de Compostela, Spain |
Recruiting | Research Site | Madrid, Spain |
Recruiting | Research Site | Birmingham, United States |
Recruiting | Research Site | Dithan, United States |
Recruiting | Research Site | Lowell, United States |
Recruiting | Research Site | Miami, United States |
Recruiting | Research Site | Miami, United States |
Recruiting | Research Site | Jacksonville, United States |
Recruiting | Research Site | Hammond, United States |
Recruiting | Research Site | Chevy Chase, United States |
Recruiting | Research Site | Rochester, United States |
Recruiting | Research Site | Mexico, United States |
Recruiting | Research Site | Egg Harbor Township, United States |
Recruiting | Research Site | Great Neck, United States |
Recruiting | Research Site | Charlotte, United States |
Recruiting | Research Site | Wilmington, United States |
Recruiting | Research Site | Nashville, United States |
Recruiting | Research Site | Germantown, United States |
Recruiting | Research Site | San Antonio, United States |
Recruiting | Research Site | Logan, United States |
Recruiting | Research Site | Ogden, United States |
Recruiting | Research Site | Calgary, Canada |
Recruiting | Research Site | Vancouver, Canada |
Recruiting | Research Site | Victoria, Canada |
Recruiting | Research Site | Winnipeg, Canada |
Recruiting | Research Site | Toronto, Canada |
Recruiting | Research Site | Hamilton, Canada |
Recruiting | Research Site | London, Canada |
Recruiting | Research Site | Montreal, Canada |
Recruiting | Research Site | Kurralta Park, Australia |
Recruiting | Research Site | Barcelona, Spain |
Recruiting | Research Site | Paris Cedex 10, France |
Recruiting | Research Site | Box Hill, Australia |
Recruiting | Research Site | Vandoeuvre les Nancy, France |
Recruiting | Research Site | Fitzroy, Australia |
Recruiting | Research Site | Paris, France |
Recruiting | Research Site | Toulouse Cedex 09, France |
Recruiting | Research Site | Nice Cedex 3, France |
Recruiting | Research Site | Maastricht, Netherlands |
Recruiting | Research Site | Bonheiden, Belgium |
Recruiting | Research Site | Gent, Belgium |
Recruiting | Research Site | Lille cedex, France |
Recruiting | Research Site | Roeselare, Belgium |
Recruiting | Research Site | Leuven, Belgium |
Recruiting | Research Site | Fremantle, Australia |
Recruiting | Research Site | Sopot, Poland |
Recruiting | Research Site | Rotterdam, Netherlands |
Recruiting | Research Site | Bydgoszcz, Poland |
Recruiting | Research Site | Olsztyn, Poland |
Recruiting | Research Site | Amsterdam, Netherlands |
Recruiting | Research Site | Barcelona, Spain |
Recruiting | Research Site | Opole, 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 Weeksenhanced_encryptionnoSafety Issue:
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 6date_rangeTime Frame:6 Weeksenhanced_encryptionnoSafety Issue:
- To evaluate improvement from baseline in CDAI at week 6date_rangeTime Frame:6 Weeksenhanced_encryptionnoSafety Issue:
- To evaluate the short term safety profile of AMG 827 in subjects with Crohn’s diseasedate_rangeTime Frame:12 Weeksenhanced_encryptionyesSafety Issue:
- To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Crohn’s diseasedate_rangeTime Frame:6 Weeksenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4