B0151005 Open-Label Extension Study



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:June 2011
End Date:March 2016

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A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

This is a multi-center Phase 2, open label, safety extension study in subjects with moderate
to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will
have completed the 12-week induction period of study B0151003 and will be enrolled as either
responders or non responders.


Inclusion Criteria:

- Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12
week) induction period.

- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

- Women of childbearing potential, who have sexual intercourse with a non surgically
sterilized male partner, must agree and commit to the use highly effective methods of
birth control from signing of the ICD through 26 weeks after the Final Study
Evaluation or for 62 weeks from the last dose of investigational product for any
subject who terminates early from this study.

Exclusion Criteria:

- Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced
serious event(s) related to the investigational product, an unstable medical
condition, or any other reason, in the opinion of the investigator, would preclude
entry or inclusion in this study.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate entry into this study.

- Received any prohibited treatment during study B0151003 that, in the opinion of the
investigator, compromised the safety or efficacy of this study.
We found this trial at
59
sites
2147 Northeast Coachman Road
Clearwater, Florida 33765
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Annapolis, Maryland 21401
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Annapolis, Maryland 21401
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Arlington Heights, Illinois 60005
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Austin, Texas 78705
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Clearwater, Florida 33756
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Concord, New South Wales
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Crystal River, Florida 34429
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Decatur, GA
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Evanston, Illinois 60201
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Germantown, Tennessee 38138
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Grand Rapids, Michigan 49546
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Hamden, CT
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Houston, Texas 77003
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Inverness, Florida 34452
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Inverness, Florida 34453
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Lakewood, CO
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Littleton, Colorado 80120
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530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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Louisville, Kentucky 40202
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Marietta, GA
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Nashville, Tennessee 37232
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New York, New York 10028
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New York, New York 10029
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New York, New York 10128
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Oklahoma, Oklahoma 73103
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Oklahoma City, Oklahoma 73104
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Oklahoma City, Oklahoma 73104
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Pittsburgh, Pennsylvania 15241
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Pittsburgh, Pennsylvania 15243
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Richmond, VA
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Salt Lake City, Utah 84132
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Scottsdale, Arizona 85260
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Scottsdale, Arizona 85258
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Southlake, Texas 76092
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Tucson, Arizona 85712
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Tulsa, Oklahoma 74101
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Tulsa, Oklahoma 74137
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Tuscon, Arizona 85712
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Tyler, TX
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Wheat Ridge, Colorado 80033
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5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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Wyoming, Michigan 49519
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Ypsilanti, Michigan 48197
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