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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

NCT01900574 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-05-11

No results posted yet for this study

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).

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Golimumab

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-09
Primary Completion
2015-02-18
Completion
2022-09-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01900574 on ClinicalTrials.gov