A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:2 - 17
Updated:3/27/2019
Start Date:October 29, 2018
End Date:September 1, 2024
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission
as assessed by the Mayo score, in pediatric participants with moderately to severely active
ulcerative colitis (UC). In addition, the safety profile of golimumab, in pediatric
participants with moderately to severely active UC will be assessed.

This is a multicenter study in pediatric participants aged 2 to 17 years with moderately to
severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with an
endoscopy subscore of greater than or equal to (>=)2. This 54-week study will consist of a
6-week short-term phase and a 48-week long-term phase followed by a study extension (Week 54
to end of study). At Week 58, participants who are eligible will continue receiving golimumab
in the study extension. The primary hypothesis is that golimumab is an effective therapy in
pediatric UC relative to historical placebo control as assessed by clinical remission based
on Mayo score. Safety will be monitored throughout the study.

Inclusion Criteria:

- Must either be currently receiving treatment with, or have a history of having failed
to respond to, or have a medical contraindication to at least 1 of the following
therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or
azathioprine OR must either have or have had a history of corticosteroid dependency
(that is an inability to successfully taper corticosteroids without a return of the
symptoms of ulcerative colitis [UC]) OR required more than 3 courses of
corticosteroids in the past year

- Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12
[endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist],
inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal
to (>=2)

- If receiving parenteral or enteral nutrition, must have been on a stable regimen for
at least 2 weeks prior to the first administration of study intervention at Week 0

- No history of latent or active tuberculosis prior to screening

- Acceptable evidence of immunity to measles, mumps, rubella, and varicella

Exclusion Criteria:

- History of liver or renal insufficiency; significant cardiac, vascular, pulmonary,
gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric
(including suicidality), or metabolic disturbances

- History of malignancy or macrophage activation syndrome (MAS) or hemophagocytic
lymphohistiocytosis (HLH)

- Have UC limited to the rectum only or to <20 percent (%) of the colon

- Presence of a stoma

- Presence or history of a fistula

- Contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor
(TNF-alpha) therapy per local prescribing information
We found this trial at
14
sites
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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Hartford, CT
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Atlanta, GA
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Aurora, CO
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15 Jean Joseph Crocqlaan
Brussel, 1020
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Brussel,
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Dallas, TX
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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Garland, Texas 75044
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Garland, TX
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Lone Tree, Colorado 80124
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Lone Tree, CO
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Rochester, Minnesota 55905
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Rochester, MN
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San Francisco, California 94143
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San Francisco, CA
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Wilmington, Delaware 19803
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Wilmington, DE
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