Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:2/20/2019
Start Date:April 9, 2014
End Date:February 3, 2020

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

This study will evaluate higher versus standard adalimumab dosing regimens for induction and
maintenance therapy in subjects with moderately to severely active Crohn's Disease and
evidence of mucosal ulceration.


Inclusion Criteria:

- Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during
the Screening Period.

- Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral
corticosteroids and/or immunosuppressants.

- Mucosal ulceration on endoscopy.

Exclusion Criteria:

- Subject with ulcerative colitis or indeterminate colitis.

- Subject who has had surgical bowel resections in the past 6 months or is planning
resection.

- Subjects with an ostomy or ileoanal pouch.

- Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

- Subject who has short bowel syndrome.

- Chronic recurring infections or active Tuberculosis (TB).
We found this trial at
49
sites
Texas Digestive Disease Consul /ID# 137283
Southlake, Texas 76092
?
mi
from
Southlake, TX
Click here to add this to my saved trials
Albany Medical College /ID# 140200
47 New Scotland Avenue
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
University of Michigan Hospitals /ID# 119076
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Digestive Disorders Associates /ID# 119033
621 Ridgely Avenue
Annapolis, Maryland 21401
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
Emory University Hospital /ID# 136851
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta Gastro Assoc /ID# 119065
5671 Peachtree Dunwoody Road
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin Center for Clinical Res /ID# 125500
Austin, Texas 78756
?
mi
from
Austin, TX
Click here to add this to my saved trials
Birmingham Gastroenterology /ID# 137282
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Commonwealth Clinical Studies /ID# 136850
Brockton, Massachusetts 02302
?
mi
from
Brockton, MA
Click here to add this to my saved trials
Medical University of South Carolina /ID# 138122
96 Jonathan Lucas Street
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte Gastro Hepatology /ID# 119041
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Erlanger Institute for Clinica /ID# 129008
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Gastro Assoc of Tidewater /ID# 135897
Chesapeake, Virginia 23320
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
MGG Group, Inc.Chevy Chase Clinical Research /ID# 119042
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
University of Chicago /ID# 119077
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Northwestern University Feinberg School of Medicine /ID# 119043
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
New River Valley Research Inst /ID# 127807
Christiansburg, Virginia 24073
?
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Consultants for Clinical Res /ID# 119052
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
TX Digestive Disease Consultan /ID# 138121
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Digestive Health Specialists of the Southeast /ID# 122483
480 Honeysuckle Road
Dothan, Alabama 36305
?
mi
from
Dothan, AL
Click here to add this to my saved trials
Gastro One /ID# 119068
1324 Wolf Park Drive
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
NYU Langone Long Island CRA /ID# 119035
Great Neck, New York 11021
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Medical Research Ctr CT /ID# 119037
Hamden, Connecticut 06518
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Baylor College of Medicine /ID# 137277
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kansas City Research Institute /ID# 119034
425 Volker Boulevard
Kansas City, Missouri 64131
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Ucsd /Id# 119053
9500 Gilman Dr
La Jolla, California 92093
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Axis Clinical Trials /ID# 130390
5800 Wilshire Boulevard
Los Angeles, California 90036
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Gastro Assoc of Central GA /ID# 119056
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
Ctr for Digest and Liver Dis /ID# 119040
Mexico, Missouri 65265
?
mi
from
Mexico, MO
Click here to add this to my saved trials
WI Center for Advanced Res /ID# 119036
Milwaukee, Wisconsin 53215
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Froedtert and Medical College /ID# 119081
Milwaukee, Wisconsin 53226
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Gastroenterology Group of Naples /ID# 122493
1064 Goodlette-Frank Road
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
Nashville Med Res Inst /ID# 119050
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Vanderbilt University Medical Center /ID# 125501
1211 Medical Center Drive
Nashville, Tennessee 37212
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Icahn School of Med Mt. Sinai /ID# 127116
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Advanced Research Institute /ID# 119048
5896 South Ridgeline Drive
Ogden, Utah 84405
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Internal Med Specialists /ID# 137737
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Minnesota Gastroenterology, P. A. /ID# 137280
Plymouth, Minnesota 55446
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
The Oregon Clinic- Gastro West /ID# 135272
Portland, Oregon 97225
?
mi
from
Portland, OR
Click here to add this to my saved trials
Wake Research Associates, LLC /ID# 119029
3100 Duraleigh Road
Raleigh, North Carolina 27612
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Mayo Clinic - Rochester /ID# 122489
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
University of Utah /ID# 119062
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Louisiana Research Center, LLC /ID# 136749
Shreveport, Louisiana 71061
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Gastro United of Tulsa /ID# 122485
Tulsa, Oklahoma 74135
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Carle Cancer Center /ID# 136008
509 West University Avenue
Urbana, Illinois 61801
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Medizinische Universität Wien /ID# 126279
Vienna, Wien
?
mi
from
Vienna,
Click here to add this to my saved trials
West Bay Clinical Research /ID# 138330
Warwick, Rhode Island 02886
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Rocky Mountain Clinical Resear /ID# 119038
Wheat Ridge, Colorado 80033
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
Shafran Gastroenterology Ctr /ID# 119057
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials