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
Clearwater, Florida 33756
2116
mi
from 91732
Clearwater, FL
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2147 Northeast Coachman Road
Clearwater, Florida 33765
2119
mi
from 91732
Clearwater, FL
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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...
1352
mi
from 91732
Houston, TX
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Annapolis, Maryland 21401
2309
mi
from 91732
Annapolis, MD
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Annapolis, Maryland 21401
2309
mi
from 91732
Annapolis, MD
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Arlington Heights, Illinois 60005
1713
mi
from 91732
Arlington Heights, IL
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Austin, Texas 78705
1211
mi
from 91732
Austin, TX
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1212
mi
from 91732
Austin, TX
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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...
1730
mi
from 91732
Chicago, IL
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Concord, New South Wales
7518
mi
from 91732
Concord,
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Crystal River, Florida 34429
2106
mi
from 91732
Crystal River, FL
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1924
mi
from 91732
Decatur, GA
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1924
mi
from 91732
Decatur, GA
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Evanston, Illinois 60201
1728
mi
from 91732
Evanston, IL
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Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
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Grand Rapids, Michigan 49546
1847
mi
from 91732
Grand Rapids, MI
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2487
mi
from 91732
Hamden, CT
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Houston, Texas 77003
1357
mi
from 91732
Houston, TX
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Inverness, Florida 34452
2122
mi
from 91732
Inverness, FL
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Inverness, Florida 34453
2123
mi
from 91732
Inverness, FL
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812
mi
from 91732
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...
1881
mi
from 91732
Lexington, KY
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Littleton, Colorado 80120
813
mi
from 91732
Littleton, CO
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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...
1813
mi
from 91732
Louisville, KY
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Louisville, Kentucky 40202
1812
mi
from 91732
Louisville, KY
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1907
mi
from 91732
Marietta, GA
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1762
mi
from 91732
Nashville, TN
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Nashville, Tennessee 37232
1762
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Nashville, TN
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1762
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Nashville, TN
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2434
mi
from 91732
New York, NY
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2351
mi
from 91732
New York, NY
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2434
mi
from 91732
New York, NY
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2435
mi
from 91732
New York, NY
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New York, New York 10028
2435
mi
from 91732
New York, NY
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New York, New York 10029
2435
mi
from 91732
New York, NY
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New York, New York 10128
2351
mi
from 91732
New York, NY
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Oklahoma, Oklahoma 73103
1164
mi
from 91732
Oklahoma, OK
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Oklahoma City, Oklahoma 73104
1165
mi
from 91732
Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
1165
mi
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Oklahoma City, OK
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Pittsburgh, Pennsylvania 15241
2119
mi
from 91732
Pittsburgh, PA
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Pittsburgh, Pennsylvania 15243
2115
mi
from 91732
Pittsburgh, PA
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2267
mi
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Richmond, VA
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2268
mi
from 91732
Richmond, VA
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Salt Lake City, Utah 84132
573
mi
from 91732
Salt Lake City, UT
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2183
mi
from 91732
Sanford, FL
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Scottsdale, Arizona 85260
353
mi
from 91732
Scottsdale, AZ
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Scottsdale, Arizona 85258
353
mi
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Scottsdale, AZ
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Southlake, Texas 76092
1203
mi
from 91732
Southlake, TX
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Tucson, Arizona 85712
430
mi
from 91732
Tucson, AZ
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Tulsa, Oklahoma 74101
1250
mi
from 91732
Tulsa, OK
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Tulsa, Oklahoma 74137
1253
mi
from 91732
Tulsa, OK
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Tuscon, Arizona 85712
430
mi
from 91732
Tuscon, AZ
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1316
mi
from 91732
Tyler, TX
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1316
mi
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Tyler, TX
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Wheat Ridge, Colorado 80033
814
mi
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Wheat Ridge, CO
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1837
mi
from 91732
Wyoming, MI
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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
1837
mi
from 91732
Wyoming, MI
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Wyoming, Michigan 49519
1836
mi
from 91732
Wyoming, MI
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Ypsilanti, Michigan 48197
1937
mi
from 91732
Ypsilanti, MI
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