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
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

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).
    

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 (Week 0 to Week 14); Part 2: study extension (Week 14 to Week 114).
      The focus of this study is to evaluate the pharmacokinetics and safety of golimumab.
      Additionally the efficacy of short-term therapy with golimumab will be evaluated.
      Participants in clinical response at Week 6 will continue to receive open label golimumab
      maintenance therapy and will enter the study extension at Week 14. Participants who are not
      in clinical response at Week 6 will be withdrawn from further treatment with golimumab. At
      Week 114, participants who, in the opinion of the investigator, may benefit from continued
      treatment will be eligible to continue to receive golimumab every 4 weeks until marketing
      authorization is obtained in the treatment of pediatric UC in that country, or until a
      decision has been made not to pursue an indication in pediatric UC. Approximately 30
      participants will be enrolled in this study. The total duration of study participation for a
      participant will be approximately 126 weeks or longer.
    

Intervention name(s): Golimumab
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Simponi
Intervention MeSH terms: Golimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colitis, Ulcerative; Ulcerative Colitis; Moderately to Severely Active Ulcerative Colitis; Golimumab; Simponi; Human anti-TNFα Antibody; Pediatric participants; Safety and Pharmacokinetics