CTRI/2022/03/040770招募中3 期
Efficacy, safety, tolerability and pharmacokinetics of tofacitinib for treatment of systemic juvenile idiopathic arthritis (sJIA) with active systemic features in children and adolescent subjects
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Active sJIA disease according to ILAR criteria before screening and at baseline (Day 1);
- •Treatment with stable doses of methotrexate (MTX) ââ?°Â¤25 mg/week or ââ?°Â¤20 mg/m2/week, whichever is lower, is permitted;
- •Treatment with a stable dose of oral prednisone ââ?°Â¤1 mg/kg/day up to a maximum of 30 mg/day, or equivalent, for at least 1 week before the first study drug dose is permitted.
排除标准
- •Previous JIA treatment with tofacitinib, baricitinib, or any other JAK-inhibitor;
- •Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with sJIA. Current symptoms or findings of more than minimal pleuritis with sJIA
- •Subjects who have previously failed treatment with more than two biologic DMARDs. Note: all subjects will be allowed to have previously failed one biologic DMARD, and up to forty (40) percent of subjects will be allowed to have previously failed two biologic DMARDs provided that washout periods are respected.
研究者
相似试验
进行中（未招募）
不适用
Efficacy, safety, tolerability and pharmacokinetics of concomitant administration of tramadol with duloxetine or pregabalin: a randomized controlled flexible-dose study in patients with neuropathic paiG53.0 Vyöruusun jälkeinen hermosärkyG63.2 Diabeteksen monihermosairausMedDRA version: 9.1Level: LLTClassification code 10036377Term: Postherpetic polyneuropathyMedDRA version: 9.1Level: LLTClassification code 10012680Term: Diabetic neuropathyEUCTR2009-013061-26-FIniversity of Turku40
招募中
不适用
Safety, tolerability, efficacy and pharmacokinetic study of increasing doses of B26826 in adult patients with known or suspected intracranial lesions referred for contrast-enhanced MRI of the brain.Intracraniële laesies verwezen voor contrastverbeterde MRI van de hersenencontrast mediumintracranial lesionsNL-OMON54381Bracco Imaging S.pA.12
进行中（未招募）
1 期
Efficacy, Safety, Tolerability and Pharmacokinetics of EXN-32 and EXN-44 in patients with Parkinson¿s Disease experiencing motor fluctuationsParkinson's Desease (PD)MedDRA version: 21.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852EUCTR2017-000262-30-ITDR. REDDY’S LABORATORIES LIMITED18
进行中（未招募）
不适用
Pharmacokinetics, efficacy, tolerability and safety evaluation of the therapy with subcutaneous immunoglobulin in the treatment of hypo or agammaglobulinaemic patients. Open label phase II/III study - NDHypogammaglobulinaemia or agammaglobulinaemiaMedDRA version: 9.1Level: LLTClassification code 10060384MedDRA version: 9.1Level: LLTClassification code 10001471EUCTR2010-020167-20-ITKEDRIO
进行中（未招募）
1 期
Efficacy and Safety Study Of Tofacitinib in Pediatric sJIA PopulatioSystemic Juvenile Idiopathic Arthritis (sJIA)EUCTR2017-002018-29-ITPFIZER INC100