Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis



Status:Active, not recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:2/17/2019
Start Date:March 27, 2014
End Date:November 15, 2019

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

Trial Summary
Trial Overview
Inclusion Criteria

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in
subjects with moderately to severely active Ulcerative Colitis.


Inclusion Criteria:

- Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy
during Screening period.

- Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite
concurrent or prior treatment with a full and adequate course, in the opinion of the
Investigator, with oral corticosteroids or immunosuppressants or both.

Exclusion Criteria:

- Subject with Crohn's disease (CD) or indeterminate colitis (IC).

- Current diagnosis of fulminant colitis and/or toxic megacolon.

- Subjects with disease limited to the rectum (ulcerative proctitis) during the
screening endoscopy.

- Chronic recurring infections or active Tuberculosis (TB).
We found this trial at
44
sites
Charlotte Gastro Hepatology /ID# 122235
Charlotte, North Carolina 28207
?
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
University of Michigan Hospitals /ID# 122240
Ann Arbor, Michigan 48109
?
mi
from 43215
Ann Arbor, MI
Click here to add this to my saved trials
Atlanta Gastro Assoc /ID# 122336
5671 Peachtree Dunwoody Road
Atlanta, Georgia 30342
424
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
Austin Center for Clinical Res /ID# 125396
Austin, Texas 78756
?
mi
from 43215
Austin, TX
Click here to add this to my saved trials
University of Maryland Med Ctr /ID# 169734
Baltimore, Maryland 21201
?
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
Erlanger Institute for Clinica /ID# 129009
Chattanooga, Tennessee 37403
?
mi
from 43215
Chattanooga, TN
Click here to add this to my saved trials
MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
Chevy Chase, Maryland 20815
?
mi
from 43215
Chevy Chase, MD
Click here to add this to my saved trials
University of Chicago /ID# 122302
Chicago, Illinois 60637
?
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
Northwestern University Feinberg School of Medicine /ID# 122183
Chicago, Illinois 60611
?
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
New River Valley Research Inst /ID# 127801
Christiansburg, Virginia 24073
?
mi
from 43215
Christiansburg, VA
Click here to add this to my saved trials
Consultants for Clinical Res /ID# 122304
Cincinnati, Ohio 45219
?
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Gastro Florida /ID# 170619
Clearwater, Florida 33756
?
mi
from 43215
Clearwater, FL
Click here to add this to my saved trials
Digestive Health Specialists of the Southeast /ID# 127844
480 Honeysuckle Road
Dothan, Alabama 36305
618
mi
from 43215
Dothan, AL
Click here to add this to my saved trials
Dayton Gastroenterology, Inc. /ID# 127804
Englewood, Ohio 45415
?
mi
from 43215
Englewood, OH
Click here to add this to my saved trials
Florida Research Network, LLC /ID# 170618
Gainesville, Florida 32605
?
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
DHAT Research Institute /ID# 170616
Garland, Texas 75044
?
mi
from 43215
Garland, TX
Click here to add this to my saved trials
Gastro One /ID# 122339
1324 Wolf Park Drive
Germantown, Tennessee 38138
500
mi
from 43215
Germantown, TN
Click here to add this to my saved trials
NYU Langone Long Island CRA /ID# 122177
Great Neck, New York 11021
?
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
Medical Research Ctr CT /ID# 122179
Hamden, Connecticut 06518
?
mi
from 43215
Hamden, CT
Click here to add this to my saved trials
Biopharma Informatic Research /ID# 171150
Houston, Texas 77084
?
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Ucsd /Id# 122313
La Jolla, California 92037
?
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
Gastro Assoc of Central GA /ID# 122318
Macon, Georgia 31201
?
mi
from 43215
Macon, GA
Click here to add this to my saved trials
Ctr for Digest and Liver Dis /ID# 122182
Mexico, Missouri 65265
?
mi
from 43215
Mexico, MO
Click here to add this to my saved trials
Research Associates of South Florida,LLC /ID# 170309
Miami, Florida 33156
?
mi
from 43215
Miami, FL
Click here to add this to my saved trials
WI Center for Advanced Res /ID# 122178
Milwaukee, Wisconsin 53215
?
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
Froedtert and Medical College /ID# 122261
Milwaukee, Wisconsin 53226
?
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
Gastroenterology Group of Naples /ID# 127806
1064 Goodlette-Frank Road
Naples, Florida 34102
956
mi
from 43215
Naples, FL
Click here to add this to my saved trials
Vanderbilt University Medical Center /ID# 125496
1211 Medical Center Drive
Nashville, Tennessee 37212
334
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
Icahn School of Med Mt. Sinai /ID# 127047
New York, New York 10029
?
mi
from 43215
New York, NY
Click here to add this to my saved trials
Advanced Research Institute /ID# 126147
5896 South Ridgeline Drive
Ogden, Utah 84405
1513
mi
from 43215
Ogden, UT
Click here to add this to my saved trials
University of Pittsburgh MC /ID# 122331
Pittsburgh, Pennsylvania 15260
?
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
The Oregon Clinic- Gastro West /ID# 135273
Portland, Oregon 97225
?
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Wake Research Associates, LLC /ID# 122157
3100 Duraleigh Road
Raleigh, North Carolina 27612
370
mi
from 43215
Raleigh, NC
Click here to add this to my saved trials
Mayo Clinic - Rochester /ID# 122244
Rochester, Minnesota 55905
?
mi
from 43215
Rochester, MN
Click here to add this to my saved trials
University of Utah /ID# 122333
Salt Lake City, Utah 84132
1510
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
University of Washington /ID# 169721
Seattle, Washington 98109
?
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Louisiana Research Center, LLC /ID# 141655
Shreveport, Louisiana 71061
787
mi
from 43215
Shreveport, LA
Click here to add this to my saved trials
Texas Digestive Disease Consul /ID# 141677
Southlake, Texas 76092
?
mi
from 43215
Southlake, TX
Click here to add this to my saved trials
Texas Digestive Disease Consul /ID# 141678
Southlake, Texas 76092
?
mi
from 43215
Southlake, TX
Click here to add this to my saved trials
Gastro United of Tulsa /ID# 125436
Tulsa, Oklahoma 74135
?
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
Carle Foundation Hospital /ID# 135955
Urbana, Illinois 61801
?
mi
from 43215
Urbana, IL
Click here to add this to my saved trials
Medizinische Universität Wien /ID# 127186
Vienna, Wien
?
mi
from 43215
Vienna,
Click here to add this to my saved trials
Rocky Mountain Clinical Resear /ID# 122180
Wheat Ridge, Colorado 80033
?
mi
from 43215
Wheat Ridge, CO
Click here to add this to my saved trials
Shafran Gastroenterology Ctr /ID# 122320
Winter Park, Florida 32789
?
mi
from 43215
Winter Park, FL
Click here to add this to my saved trials