EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (sJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS - .

PFIZER INC0 个研究点目标入组 100 人2020年11月6日

适应症Systemic Juvenile Idiopathic Arthritis (sJIA)Therapeutic area: Diseases [C] - Immune System Diseases [C20]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Systemic Juvenile Idiopathic Arthritis (sJIA)
发起方: PFIZER INC
入组人数: 100
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年11月6日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

PFIZER INC

入排标准

入选标准

•Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study:
•1\.Male or female aged 2 to \<18 years.
•2\.Diagnosed with sJIA according to International League Against Rheumatism (ILAR) criteria, and, in the opinion of the investigator, have active disease for at least 6 weeks prior to screening. Subjects must have active disease at the time of enrollment, defined as:
•a.Documented intermittently spiking temperature \>38°C/100\.4°F for at least 1 day due to sJIA in the screening period and within 1 week before the first dose, and the presence of at least 2 joints with active arthritis at screening and baseline, and an ESR \>30 mm/hr \[1\.5 X ULN] at screening.
•b.Only after cohort review is completed and enrollment is opened without restrictions at a particular dose level: The presence of at least 5 joints with active arthritis at screening and baseline, and an ESR \>30 mm/hr \[1\.5 X ULN] at screening. Refer to Section 3\.4 of the protocol for details.
•3\.Treatment with stable doses of methotrexate (MTX) and/or oral CSs is permitted:
•For subjects taking MTX: Treatment for \=3 months with MTX and with a stable dose of MTX (dose must be \=25 mg/wk or \=20 mg/m2/week, whichever is lower) for at least 6 weeks before the first study drug dose (Day 1\). Subjects taking MTX must be taking folic acid or folinic acid in accordance with local standards.
•For subjects taking CS: Treatment with a stable dose of oral prednisone (\=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 (Day 1\).
•4\.No evidence or history of untreated or inadequately treated active or latent tuberculosis (TB) infection as evidenced by the following:
•A negative QuantiFERON® TB Gold or Glod Plus In Tube test performed within the 3 months prior to screening. A negative purified protein derivative (PPD) test can be substituted for the QuantiFERON® TB Gold or Gold Plus In Tube test only if the central laboratory is unable to perform the test or cannot determine the results to be positive or negative and the Pfizer medical monitor is informed and agrees on a case by case basis.

排除标准

•Subjects with any of the following characteristics/conditions will not be included in the study:
•1\.Previous JIA treatment with tofacitinib.
•2\.Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with sJIA.
•3\.Current symptoms or findings of more than minimal pleuritis with sJIA.
•4\.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, provided that the washout periods indicated in Section 5\.8\.1\.2
•of the protocol are respected. Up to forty (40\) percent of subjects will be allowed to have previously failed two biologic DMARDs in accordance with the washout periods in Section 5\.8\.1\.2 of the protocol.
•5\.Infections:
•a.Chronic infections;
•b.Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug;
•c.Any treated infections within 2 weeks of baseline;