Status:
COMPLETED
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participant...
Detailed Description
This is an open-label (both \[participants and investigator\] know what treatment participants will receive) and multicenter study. The study is divided into 2 parts: Part 1: pharmacokinetics portion ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Moderate to severe Ulcerative Colitis (UC) defined by a Mayo score (a score used to assess the treatment for UC) of 6 to 12 inclusive, including an endoscopic subscore of 2 or more.
- 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 and azathioprine OR must either have or have had a history of corticosteroid dependency (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC) OR required more than 3 courses of corticosteroids in the past year
- No history of latent or active tuberculosis prior to screening
- Positive protective antibody titers to varicella and measles prior to the first administration of study agent
- Exclusion criteria:
- Have severe extensive UC that is likely to require a colectomy (surgical removal of the colon) within 12 weeks of study entry
- Have UC limited to the rectum only or to less than 20 cm of the colon
- Presence of a stoma
- Presence or history of a fistula
- Have evidence of Crohn's disease (an inflammatory large intestine disease)
- Previous exposure to anti-tumor necrosis factor therapy
Exclusion
Key Trial Info
Start Date :
August 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01900574
Start Date
August 9 2013
End Date
September 1 2022
Last Update
May 11 2023
Active Locations (27)
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1
Phoenix, Arizona, United States
2
Los Angeles, California, United States
3
San Francisco, California, United States
4
Hartford, Connecticut, United States