Date: 2014-10-27
Type of information: Initiation of patient enrollment
phase: 3
Announcement: initiation of the trial
Company: Janssen Research & Development, a J&J company (USA - NJ)
Product: Simponi Aria® (golimumab)
Action
mechanism: monoclonal antibody. Golimumab is a human monoclonal antibody that targets and neutralises excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. This drug is approved in 85 countries for rheumatologic indications (moderate-to-severe, active rheumatoid arthritis in combination with methotrexate, active and progressive psoriatic arthritis alone or in combination with methotrexate and for the treatment of severe, active ankylosing spondylitis).
Disease: polyarticular juvenile idiopathic arthritis in pediatric patients (o through 16 years of age)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rare diseases - Rheumatic diseases
Country:
Trial
details: GO-VIVA is a phase 3 study to evaluate the pharmacokinetics, efficacy and safety of intravenous golimumab in pediatric participants with active polyarticular course juvenile idiopathic arthritis despite methotrexate therapy. 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) (NCT02277444)
Latest
news: * On October 27, 2014, Janssen Research & Development has registered a phase 3 study of golimumab in pediatric participants with active polyarticular course juvenile idiopathic arthritis despite methotrexate therapy. The GO-VIVA study will 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).
