drugset / Trial / NCT01900574
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
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2013-08-09
- Primary completion
- 2015-02-18
- Completion
- 2022-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Golimumab | Monoclonal antibody | 22.5 mg/m2 | Subcutaneous |
| Subject | Golimumab | Monoclonal antibody | 45 mg/m2 | Subcutaneous |
| Subject | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Golimumab | Monoclonal antibody | 100 mg | Subcutaneous |