A multicenter, open-label study to assess the pharmacokinetics, safety and efficacy of Certolizumab pegol in children and adolescents with moderately to severely active polyarticular-course JuvenileIdiopathic Arthritis (JIA) - PASCAL: Pediatric Arthritis Study of CertolizumAb pego

CB BIOSCIENCES GmbH0 个研究点开始时间: 2015年4月14日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Subjects must have had polyarticular juvenile idiopathic arthritis (JIA) for at least 6 months prior to baseline (polyarticular JIA is defined as more than or equal to 5 joints with active arthritis, including: polyarthritis rheumatoid factor positive, polyarthritis rheumatoid factor negative, extended oligoarthritis, psoriatic arthritis, juvenile arthritis and enthesitis-related arthritis (ERA)). The study population will consist of 2-17 year-old subjects in the inclusion with a minimum weight of 10 kg. Subjects must have had an inadequate response or intolerance to at least one disease modifying anti-rheumatic drug (DMARD). Methotrexate (MTX) and oral corticosteroids will be allowed at stable doses prior to Screening. If not using Methotrexate, subjects must have had an inadequate response or intolerance to Methotrexate (MTX).

•Subjects with a history of systemic juvenile idiopathic arthritis (JIA), with or without systemic features. Subjects have active uveitis or a history of active uveitis within preceding 6 months to baseline. Known history of Tuberculosis (TB), or high risk of acquiring TB and latent TB infection; chronic, recurrent infection current sign or symptom which may indicate infection, or at high risk of infection. Viral Hepatitis or Human Immunodeficiency Virus (HIV) infection; live vaccination, including attenuated, within defined period prior to study entry or during the study (non-live vaccinations are permitted at any time prior to and during the study). The use of, or dose changes to, specific medications (eg, non-biologic DMARDs, biologic DMARDs, oral and intramuscular/intravenous/intra-articular Corticosteroids) will not be allowed for defined periods of time prior to study entry. Previous exposure to Certolizumab Pegol (CZP), to more than 2 biologic DMARDs and previous lack of response to more than 1 Tumor Necrosis Factor (TNFalpha)antagonist drug.

发起方

CB BIOSCIENCES GmbH