Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:11/18/2017
Start Date:August 12, 2014
End Date:November 3, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

This study will evaluate the long term efficacy, safety, and tolerability of repeated
administration of adalimumab in subjects with Crohn's disease.


Inclusion Criteria:

- Subject successfully enrolled in and completed Study M14-115, including the Week 12
ileocolonoscopy.

Exclusion Criteria:

- If the Week 12 (Study M14-115) colonoscopy shows evidence of dysplasia or malignancy.

- Subject is not in compliance with prior and concomitant medication requirements
throughout M14-115.

- Subject who developed active Tuberculosis (TB) during M14-115, or subject who is non
compliant with prophylaxis for latent TB initiated per M14-115 procedures.
We found this trial at
47
sites
Medical Research Center of Connecticut, LLC /ID# 128009
2200 Whitney Avenue
Hamden, Connecticut 06518
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Hamden, CT
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Albany Medical College /ID# 139462
47 New Scotland Avenue
Albany, New York 12208
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Albany, NY
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University of Michigan /ID# 128017
500 South State Street
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Digestive Disorders Associates /ID# 128005
621 Ridgely Avenue
Annapolis, Maryland 21401
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Annapolis, MD
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Emory University /ID# 136894
Atlanta, Georgia 30322
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Atlanta, GA
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Atlanta Gastro Assoc /ID# 128025
5671 Peachtree Dunwoody Road
Atlanta, Georgia 30342
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Atlanta, GA
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Austin Center for Clinical Research /ID# 128003
Austin, Texas 78756
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Austin, TX
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Birmingham Gastroenterology Associates, P.C. /ID# 137988
1 Independence Plaza
Birmingham, Alabama 35209
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Birmingham, AL
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Commonwealth Clinical Studies /ID# 136904
Brockton, Massachusetts 02302
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Brockton, MA
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Medical University of South Carolina Women's Health Research /ID# 137595
135 Cannon Street
Charleston, South Carolina 29425
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Charleston, SC
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Carolinas Medical Center /ID# 136895
1000 Blythe Boulevard
Charlotte, North Carolina 28203
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Charlotte, NC
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Charlotte Gastroenterology and Hepatology, PLLC /ID# 128011
2015 Randolph Road
Charlotte, North Carolina 28207
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Charlotte, NC
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Erlanger Institute for Clinical Research /ID# 130310
975 East 3rd Street
Chattanooga, Tennessee 37403
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Chattanooga, TN
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Gastroenterology Associates of Tidewater /ID# 136332
112 Gainsborough Square
Chesapeake, Virginia 23320
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Chesapeake, VA
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MGG Group, Inc. /ID# 128016
Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Northwestern University /ID# 129300
303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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University of Chicago Medical Center /ID# 132710
5841 South Maryland Avenue
Chicago, Illinois 60637
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Chicago, IL
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New River Valley Research Institute /ID# 129303
110 Akers Farm Road Northeast
Christiansburg, Virginia 24073
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Christiansburg, VA
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Consultants for Clinical Research /ID# 128024
2925 Vernon Place
Cincinnati, Ohio 45219
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Cincinnati, OH
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Texas Digestive Disease Consultants /ID# 139444
Dallas, Texas 75231
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Dallas, TX
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Digestive Health Specialists of the Southeast /ID# 129301
480 Honeysuckle Road
Dothan, Alabama 36305
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Dothan, AL
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Gastro One /ID# 128026
1324 Wolf Park Drive
Germantown, Tennessee 38138
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Germantown, TN
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NYU Langone Long Island Clinical Research Assoc., LLP /ID# 128007
1000 Northern Boulevard
Great Neck, New York 11021
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Great Neck, NY
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Ordination Hainburg an der Donau, Altes Kloster /ID# 128086
1a Fabriksplatz
Hainburg/Donau, 2410
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Hainburg/Donau,
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Kansas City Research Institute /ID# 128006
425 Volker Boulevard
Kansas City, Missouri 64131
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Kansas City, MO
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Ucsd /Id# 129304
9500 Gilman Dr
La Jolla, California 92093
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La Jolla, CA
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Axis Clinical Trials /ID# 130313
5800 Wilshire Boulevard
Los Angeles, California 90036
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Los Angeles, CA
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Gastroenterology Associates of Central Georgia, LLC /ID# 128030
610 3rd Street
Macon, Georgia 31201
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Macon, GA
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Center for Digestive and Liver Disease, Inc. /ID# 128010
714 Medical Park Drive
Mexico, Missouri 65265
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Mexico, MO
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Wisconsin Center for Advanced Research GI Associates, LLC /ID# 128008
3201 South 16th Street
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Medical College of Wisconsin at Froedtert Memorial Lutheran /ID# 128022
9200 West Wisconsin Avenue
Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Gastroenterology Group of Naples /ID# 129302
1064 Goodlette-Frank Road
Naples, Florida 34102
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Naples, FL
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Vanderbilt University Medical Center /ID# 128004
1211 Medical Center Drive
Nashville, Tennessee 37212
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Nashville, TN
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Mount Sinai Medical Center /ID# 129299
New York, New York 10029
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New York, NY
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Advanced Research Institute /ID# 128020
5896 South Ridgeline Drive
Ogden, Utah 84405
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Ogden, UT
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Internal Medicine Specialists /ID# 137594
3885 Oakwater Circle
Orlando, Florida 32806
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Orlando, FL
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Minnesota Gastroenterology, P.A. /ID# 136899
15700 37th Avenue North
Plymouth, Minnesota 55446
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Plymouth, MN
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The Oregon Clinic - P.C. Gastroenterology West /ID# 138008
9701 Southwest Barnes Road
Portland, Oregon 97225
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Portland, OR
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Wake Research Associates, LLC /ID# 129229
3100 Duraleigh Road
Raleigh, North Carolina 27612
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Raleigh, NC
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Mayo Clinic /ID# 128019
200 1st Street Southwest
Rochester, Minnesota 55905
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Rochester, MN
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University of Utah /ID# 130311
Salt Lake City, Utah 84132
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Salt Lake City, UT
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Louisiana Research Center, LLC /ID# 137979
Shreveport, Louisiana 71061
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Shreveport, LA
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Texas Digestive Disease Consultants /ID# 136900
Southlake, Texas 76092
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Southlake, TX
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Gastroenterology United of Tulsa /ID# 128018
3345 South Harvard Avenue
Tulsa, Oklahoma 74135
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Tulsa, OK
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Carle Cancer Center /ID# 136308
509 West University Avenue
Urbana, Illinois 61801
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Urbana, IL
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West Bay Clinical Research /ID# 138482
Warwick, Rhode Island 02886
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Warwick, RI
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Shafran Gastroenterology Center, Winter Park, FL /ID# 129305
701 West Morse Boulevard
Winter Park, Florida 32789
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Winter Park, FL
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