None listed
Conditions
Interventions
Tocilizumab 162mg/0.9mL solution for injection, subcutaneously, children under 18 years, 52 weeks, the administration is every 2 or 3 weeks according to the weight of the child participant
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
1 Years to 17 Years
Inclusion criteria
Inclusion criteria: Ages 1 up to and including 17 years at screening • Diagnosis of pcJIA according to International League of Associations for Rheumatology classification o Rheumatoid factor (RF)-positive polyarticular JIA (pJIA) o RF-negative pJIA o Extended oligoarticular JIA with a polyarticular course • History of inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate (MTX). Patients currently receiving TCZ by the IV route of administration and with well-controlled disease do not require a period of discontinuation of IV TCZ and should have their first dose of SC TCZ administered on the date that their next IV TCZ infusion would be due. Concurrent treatment with DMARDs (including MTX), NSAIDs, and oral corticosteroids are permitted at the discretion of the investigator.
Exclusion criteria
Exclusion criteria: Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity) • Patients with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ • pcJIA that is well controlled by any treatment agent other than TCZ (JADAS-71 ≤ 3.8) • Patients who are wheelchair-bound or bedridden • Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets • Lack of recovery from recent surgery or an interval of < 6 weeks since surgery at the time of the screening visit • Females who are pregnant, lactating, or intending to become pregnant during study conduct • Any significant concurrent medical or surgical condition that would jeopardize the patient’s safety or ability to complete the study, including, but not limited to, disease of the nervous, renal, hepatic, cardiac, pulmonary, or endocrine system • Known human immunodeficiency virus infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system • History of alcohol, drug, or chemical abuse within 6 months of screening • Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit • History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit • Positive TB test at screening unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug • History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein−Barr virus within 2 months of the screening visit • Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis • History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn’s disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
Countries
Argentina, Australia, Brazil, Canada, France, Germany, Italy, Poland, Russian Federation, Spain, United Kindgdom, United States
Contacts
Public ContactPatricia Elizabeth Matos
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed