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
Birmingham Gastroenterology Associates, P.C. /ID# 137988
1 Independence Plaza
Birmingham, Alabama 35209
1786
mi
from 91732
Birmingham, AL
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Albany Medical College /ID# 139462
47 New Scotland Avenue
Albany, New York 12208
2439
mi
from 91732
Albany, NY
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University of Michigan /ID# 128017
500 South State Street
Ann Arbor, Michigan 48109
1931
mi
from 91732
Ann Arbor, MI
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Digestive Disorders Associates /ID# 128005
621 Ridgely Avenue
Annapolis, Maryland 21401
2308
mi
from 91732
Annapolis, MD
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Emory University /ID# 136894
Atlanta, Georgia 30322
1922
mi
from 91732
Atlanta, GA
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Atlanta Gastro Assoc /ID# 128025
5671 Peachtree Dunwoody Road
Atlanta, Georgia 30342
1919
mi
from 91732
Atlanta, GA
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Austin Center for Clinical Research /ID# 128003
Austin, Texas 78756
1211
mi
from 91732
Austin, TX
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Commonwealth Clinical Studies /ID# 136904
Brockton, Massachusetts 02302
2581
mi
from 91732
Brockton, MA
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Medical University of South Carolina Women's Health Research /ID# 137595
135 Cannon Street
Charleston, South Carolina 29425
2183
mi
from 91732
Charleston, SC
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Carolinas Medical Center /ID# 136895
1000 Blythe Boulevard
Charlotte, North Carolina 28203
2102
mi
from 91732
Charlotte, NC
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Charlotte Gastroenterology and Hepatology, PLLC /ID# 128011
2015 Randolph Road
Charlotte, North Carolina 28207
2103
mi
from 91732
Charlotte, NC
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Erlanger Institute for Clinical Research /ID# 130310
975 East 3rd Street
Chattanooga, Tennessee 37403
1854
mi
from 91732
Chattanooga, TN
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Gastroenterology Associates of Tidewater /ID# 136332
112 Gainsborough Square
Chesapeake, Virginia 23320
2340
mi
from 91732
Chesapeake, VA
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MGG Group, Inc. /ID# 128016
Chevy Chase, Maryland 20815
2278
mi
from 91732
Chevy Chase, MD
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Northwestern University /ID# 129300
303 East Superior Street
Chicago, Illinois 60611
1730
mi
from 91732
Chicago, IL
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University of Chicago Medical Center /ID# 132710
5841 South Maryland Avenue
Chicago, Illinois 60637
1730
mi
from 91732
Chicago, IL
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New River Valley Research Institute /ID# 129303
110 Akers Farm Road Northeast
Christiansburg, Virginia 24073
2108
mi
from 91732
Christiansburg, VA
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Consultants for Clinical Research /ID# 128024
2925 Vernon Place
Cincinnati, Ohio 45219
1880
mi
from 91732
Cincinnati, OH
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Texas Digestive Disease Consultants /ID# 139444
Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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Digestive Health Specialists of the Southeast /ID# 129301
480 Honeysuckle Road
Dothan, Alabama 36305
1897
mi
from 91732
Dothan, AL
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Gastro One /ID# 128026
1324 Wolf Park Drive
Germantown, Tennessee 38138
1600
mi
from 91732
Germantown, TN
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NYU Langone Long Island Clinical Research Assoc., LLP /ID# 128007
1000 Northern Boulevard
Great Neck, New York 11021
2448
mi
from 91732
Great Neck, NY
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Ordination Hainburg an der Donau, Altes Kloster /ID# 128086
1a Fabriksplatz
Hainburg/Donau, 2410
6111
mi
from 91732
Hainburg/Donau,
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Medical Research Center of Connecticut, LLC /ID# 128009
2200 Whitney Avenue
Hamden, Connecticut 06518
2487
mi
from 91732
Hamden, CT
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Kansas City Research Institute /ID# 128006
425 Volker Boulevard
Kansas City, Missouri 64131
1340
mi
from 91732
Kansas City, MO
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Ucsd /Id# 129304
9500 Gilman Dr
La Jolla, California 92093
93
mi
from 91732
La Jolla, CA
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Axis Clinical Trials /ID# 130313
5800 Wilshire Boulevard
Los Angeles, California 90036
19
mi
from 91732
Los Angeles, CA
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Gastroenterology Associates of Central Georgia, LLC /ID# 128030
610 3rd Street
Macon, Georgia 31201
1974
mi
from 91732
Macon, GA
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Center for Digestive and Liver Disease, Inc. /ID# 128010
714 Medical Park Drive
Mexico, Missouri 65265
1485
mi
from 91732
Mexico, MO
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Wisconsin Center for Advanced Research GI Associates, LLC /ID# 128008
3201 South 16th Street
Milwaukee, Wisconsin 53215
1727
mi
from 91732
Milwaukee, WI
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Medical College of Wisconsin at Froedtert Memorial Lutheran /ID# 128022
9200 West Wisconsin Avenue
Milwaukee, Wisconsin 53226
1723
mi
from 91732
Milwaukee, WI
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Gastroenterology Group of Naples /ID# 129302
1064 Goodlette-Frank Road
Naples, Florida 34102
2220
mi
from 91732
Naples, FL
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Vanderbilt University Medical Center /ID# 128004
1211 Medical Center Drive
Nashville, Tennessee 37212
1762
mi
from 91732
Nashville, TN
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Mount Sinai Medical Center /ID# 129299
New York, New York 10029
2435
mi
from 91732
New York, NY
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Advanced Research Institute /ID# 128020
5896 South Ridgeline Drive
Ogden, Utah 84405
591
mi
from 91732
Ogden, UT
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Internal Medicine Specialists /ID# 137594
3885 Oakwater Circle
Orlando, Florida 32806
2185
mi
from 91732
Orlando, FL
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Minnesota Gastroenterology, P.A. /ID# 136899
15700 37th Avenue North
Plymouth, Minnesota 55446
1501
mi
from 91732
Plymouth, MN
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The Oregon Clinic - P.C. Gastroenterology West /ID# 138008
9701 Southwest Barnes Road
Portland, Oregon 97225
829
mi
from 91732
Portland, OR
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Wake Research Associates, LLC /ID# 129229
3100 Duraleigh Road
Raleigh, North Carolina 27612
2214
mi
from 91732
Raleigh, NC
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Mayo Clinic /ID# 128019
200 1st Street Southwest
Rochester, Minnesota 55905
1524
mi
from 91732
Rochester, MN
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University of Utah /ID# 130311
Salt Lake City, Utah 84132
573
mi
from 91732
Salt Lake City, UT
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Louisiana Research Center, LLC /ID# 137979
Shreveport, Louisiana 71061
1401
mi
from 91732
Shreveport, LA
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Texas Digestive Disease Consultants /ID# 136900
Southlake, Texas 76092
1203
mi
from 91732
Southlake, TX
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Gastroenterology United of Tulsa /ID# 128018
3345 South Harvard Avenue
Tulsa, Oklahoma 74135
1253
mi
from 91732
Tulsa, OK
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Carle Cancer Center /ID# 136308
509 West University Avenue
Urbana, Illinois 61801
1685
mi
from 91732
Urbana, IL
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West Bay Clinical Research /ID# 138482
Warwick, Rhode Island 02886
2560
mi
from 91732
Warwick, RI
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Shafran Gastroenterology Center, Winter Park, FL /ID# 129305
701 West Morse Boulevard
Winter Park, Florida 32789
2184
mi
from 91732
Winter Park, FL
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