|Clinical Trial Title||A Multicenter, Open-Label Trial of Intravenous Golimumab, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis (GO VIVA)|
|Trial Status||Closed to Enrollment|
|Trial Type||Pediatric Rheumatology|
|Specific Condition||Juvenile Idiopathic Arthritis|
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA).
This is a single arm, open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study) study to determine the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), efficacy (effectiveness) and safety of intravenous golimumab in participants with pJIA despite current treatment with methotrexate (MTX). The study will consist of 3 parts: Screening Phase (6 weeks), an open-label treatment Phase (consists of golimumab and MTX treatment for 244 weeks, wherein after week 28, MTX dose change is allowed) and follow-up Phase (8 weeks). The maximal study duration for a participant will not exceed 252 weeks. All the eligible participants will be administered golimumab IV infusion and commercial MTX. Blood samples will be collected for evaluation of pharmacokinetics of study treatment. Participants' safety will be monitored throughout the study.
Study status is:
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
|Principal Investigator||Daniel Kingsbury, MD|
|Contact Name||Kristin Hickey|