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
A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis
3 other identifiers
interventional
35
10 countries
27
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 participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2013
Longer than P75 for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedStudy Start
First participant enrolled
August 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMay 11, 2023
May 1, 2023
1.5 years
July 12, 2013
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum golimumab concentrations at Week 6
Sample will be collected prior to the administration of study medication.
Week 6
Secondary Outcomes (5)
Number of participants who will achieve clinical response at Week 6
Week 6
Number of participants who will achieve clinical remission at Week 6 measured by the Mayo score
Week 6
Number of participants who will achieve clinical remission at Week 6 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score
Week 6
Number of participants with mucosal healing at Week 6
Week 6
Number of participants who will achieve clinical remission at Week 54 and Week 110 measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) score
Week 54 and Week 110
Study Arms (1)
Golimumab
EXPERIMENTALInterventions
Golimumab will be administered subcutaneously. For participants weighing less than 45 kg, the dose of golimumab at Week 0 will be 90 mg/m2 (up to 200 mg) and 45 mg/m2 (up to 100 mg) at Weeks 2, 6, and 10. For participants weighing 45 kg or more, the dose of golimumab at Week 0 will be 200 mg and 100 mg at Weeks 2, 6, and 10. From Week 14, the dose of golimumab will be 45 mg/m2 and 100 mg, every 4 weeks for participants weighing less than 45 kg and 45 kg or more, respectively. From Week 18, participants weighing 45 kg or more have the option to administer golimumab at home after being properly trained. At Week 14 or at any time after, the participants have the option to decrease their dose of golimumab to 50 mg (weighing 45 kg or more) or 22.5 mg/square meter (less than 45 kg) at the discretion of the investigator. A single dose increase back to 100 mg or 45 mg/m2 is permitted based on the investigator's assessment of an increase in a participant's ulcerative colitis disease activity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Hartford, Connecticut, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
Morristown, New Jersey, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Graz, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Brussels, Belgium
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Halifax, Nova Scotia, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Aarhus, Denmark
Unknown Facility
Hvidovre, Denmark
Unknown Facility
Paris, France
Unknown Facility
Aachen, Germany
Unknown Facility
München, Germany
Unknown Facility
Beersheba, Israel
Unknown Facility
Haifa, Israel
Unknown Facility
Jerusalem, Israel
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Rotterdam, Netherlands
Unknown Facility
Rzeszow Poland, Poland
Unknown Facility
Warsaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 16, 2013
Study Start
August 9, 2013
Primary Completion
February 18, 2015
Study Completion
September 1, 2022
Last Updated
May 11, 2023
Record last verified: 2023-05