An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis



Status:Terminated
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:August 2007
End Date:May 2009

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

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148)
therapy in participants with active ulcerative colitis (UC) (sores in the colon).

This is a randomized (study medication assigned by chance), double-blind (neither the
Physician nor the participant know about the study medication), placebo-controlled (an
inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical
trial with a drug to test if the drug has a real effect), parallel-group (a medical research
study comparing the response in 2 or more groups of participants receiving different
interventions [treatments]) study to evaluate an appropriate intravenous (through a vein in
the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous
induction dosing with golimumab in participants with moderately to severely active UC. At
Week 6, participants will be asked to participate in an additional 1-year maintenance study.
Participants not entering the 1-year golimumab maintenance study will be evaluated for safety
at Week 16. The duration of study will be 6 weeks for participants who enter the 1-year
golimumab maintenance study and 16 weeks for participant who do not enter the 1-year
golimumab maintenance study.There are 2 parts in this study. Part 1 is Phase 2 "dose-ranging"
portion of study. Participants enrolled in Part 1, will receive a single intravenous infusion
of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or
4 mg per kg of golimumab. Part 2 of the study is called "dose-confirming" and newly enrolled
participants will receive same doses studied in Part 1, until the doses for Part 2 are
selected and Phase 3 begins. At the time that the final doses are selected, all newly
enrolled participants will receive 1 of the selected doses or matching placebo; this is the
start of the Phase 3 portion of the study. Participants will primarily be assessed using Mayo
Score (it is a score developed for measuring disease activity). Participants' safety and
quality of life will also be monitored throughout the study.

Inclusion Criteria:

- Participants diagnosed with moderately to severely active ulcerative colitis (UC)
defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an
endoscopic (examination of an internal part of the body with a lighted tube; looking
at a part of the body with a lighted tube) subscore of greater than or equal to 2

- Participants must have biopsy results (collected at the screening endoscopy (procedure
or obtained within the last year) consistent with the diagnosis of UC

- Participants either currently receiving treatment with, or have a history of failure
to respond to, or tolerate, at least 1 of the following therapies: oral
5-aminosalicylate (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and
azathioprine (AZA)

- Participants with current dependency or with a history of corticosteroid dependency
(i.e. an inability to successfully taper corticosteroids without a return of the
symptoms of UC) - Not have a diagnosis of active TB

Exclusion Criteria:

- Participants with previous exposure to biologic anti-tumor necrosis factor (TNF)
agents

- Participants with severe extensive UC that is likely to require a colectomy (surgery
to remove part or all of the colon) within 12 weeks of study entry

- Participants having UC limited to the rectum only or to less than 20 centimeter (cm)
of the colon

- Presence of a stoma (an artificial permanent opening especially in the abdominal wall
made in surgical procedures) or presence of a fistula

- Participants with a history of extensive colonic resection
We found this trial at
37
sites
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
10147
mi
from 43215
Adelaide,
Click here to add this to my saved trials
1069
mi
from 43215
Austin, TX
Click here to add this to my saved trials
1998
mi
from 43215
Bellevue, WA
Click here to add this to my saved trials
539
mi
from 43215
Bristol, CT
Click here to add this to my saved trials
590
mi
from 43215
Burlington, VT
Click here to add this to my saved trials
Charleston, South Carolina 29412
527
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
350
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
241
mi
from 43215
Christiansburg, VA
Click here to add this to my saved trials
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
426
mi
from 43215
Columbia, SC
Click here to add this to my saved trials
161
mi
from 43215
Dearborn, MI
Click here to add this to my saved trials
604
mi
from 43215
Fort Dodge, IA
Click here to add this to my saved trials
994
mi
from 43215
Galveston, TX
Click here to add this to my saved trials
501
mi
from 43215
Germantown, TN
Click here to add this to my saved trials
492
mi
from 43215
Great Neck, NY
Click here to add this to my saved trials
508
mi
from 43215
Huntington, NY
Click here to add this to my saved trials
440
mi
from 43215
Kinston, NC
Click here to add this to my saved trials
334
mi
from 43215
Laurel, MD
Click here to add this to my saved trials
609
mi
from 43215
Lebanon, NH
Click here to add this to my saved trials
1164
mi
from 43215
Littleton, CO
Click here to add this to my saved trials
188
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
394
mi
from 43215
Madison, WI
Click here to add this to my saved trials
474
mi
from 43215
Mexico, MO
Click here to add this to my saved trials
335
mi
from 43215
Milwaukee, WI
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
1959
mi
from 43215
Orange, CA
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
341
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
2028
mi
from 43215
Roseville, CA
Click here to add this to my saved trials
395
mi
from 43215
St. Louis, MO
Click here to add this to my saved trials
831
mi
from 43215
Tampa, FL
Click here to add this to my saved trials
679
mi
from 43215
Topeka, KS
Click here to add this to my saved trials
181
mi
from 43215
Troy, MI
Click here to add this to my saved trials
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials