EUCTR2017-002018-29-IT进行中（未招募）1 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 - .
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- PFIZER INC
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Chest radiograph without changes suggestive of active tuberculosis (TB) infection within 3 months prior to screening is recommended and should be performed according to local standards of care or country specific guidelines.
- •No history of either untreated or inadequately treated latent or active TB infection.
- •5.Fertile males and females who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be willing and able to use a highly effective method of contraception as outlined in this protocol during the study and for at least 28 days after the last dose of study medication (see Section 4.4.1 of the protocol).
- •Country-specific amendment for EU sites (including UK): Subjects who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must agree to use 2 methods of contraception (at least one of which is considered to be highly effective with low user dependency as defined below) throughout the study and for at least 28 days (90 days for male subjects) after the last dose of study drug where there is known or suspected teratogenicity. (see Section 4.4.1 of the protocol).
- •6.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedu
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;
- •d.A subject known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C (see Section 7.2.8 of the protocol);
- •e.History of infected joint prosthesis with prosthesis still in situ.
- •6.History of recurrent (more than one episode) herpes zoster or disseminated (at least one episode) herpes zoster, or disseminated (at least one episode) herpes simplex.
- •7.Diagnosis of active Macrophage Activation Syndrome (MAS) within 3 months prior to the first dose of study drug.
- •8.Blood dyscrasias, including (see Appendix 7 of the protocol):
- •a.Hemoglobin <9 g/dL;
- •b.White Blood Cell count <3.0 x 109/L;
- •c.Absolute Neutrophil count <1.2 x 109/L;
- •d.Platelet count <100 x 109/L;
- •e.Absolute Lymphocyte count <0.75 x 109/L.
- •9.Estimated glomerular filtration rate [GFR] <40 mL/min/1.73 m2 at Screening. GFR will be calculated by the central lab using the bedside Schwartz formula (see Appendix 4 of the protocol).
- •10.Current or recent history of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
- •11.Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =1.5 times the upper limit of normal or any other clinically significant laboratory abnormality (see Appendix 7 of the protocol).
- •12.History of any other rheumatologic disease, other than Sjogren’s syndrome.
- •13.History or current symptoms suggestive of lymphoproliferative disorders (eg, Epstein Barr Virus [EBV] related lymphoproliferative disorder, lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease).
- •14.Vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, or is expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of study drug.
- •15.Subjects without documented evidence of prior exposure to varicella zoster virus (VZV) based on positive serological testing st screening (ie, VZV IgG Ab).
- •16.Current malignancy or history of any malignancy with the exception of adequately treated or excised basal cell or squamous cell or cervical cancer in situ.
- •17.Subjects with a first degree relative with a hereditary immunodeficiency; IgA deficiency not exclusionary.
- •See the protocol for a full exclusion criteria list.
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