NL-OMON51984撤回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 - A3921165
Syneos Health Netherlands B.V0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 2
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
- 年龄范围
- 2 至 17（—）
入选标准
- •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, prior to screening.
- •Subjects with first-degree relatives with history of psoriasis, ankylosing
- •spondylitis, enthesis-related arthritis, sacroiliitis with inflammatory bowel
- •disease, Reiter's syndrome, or acute anterior uveitis may be allowed for
- •enrollment after consultation with the sponsor. Subjects must have active
- •disease at the time of enrollment defined as:
- •a.Documented intermittently spiking temperature >38*C 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
- •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 46 weeks before the first study drug dose (Day 1). Subjects taking
- •MTX must be taking folic acid or folinic acid in accordance with local
- •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
- •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
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 are still within the washout periods for disallowed
- •nonbiological and biological DMARDs as indicated in Section 5.8.1.2 of the
- •5.Infections:
- •a.Chronic infections;
- •b.Any infection requiring hospitalization, parenteral antimicrobial therapy or
- •judged to be opportunistic by the investigator within the 3 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 there
- •are household members that require oral polio vaccination (see Section 4.5.2
- •Vaccination in Household Members) during treatment or during the 6 weeks
- •following discontinuation of study drug.
- •15.Current malignancy or history of any malignancy with the exception of
- •adequately treated or excised basal cell or squamous cell carcinoma of the skin
- •or cervical carcinoma in situ.
- •16.Subjects with a first degree relative with a hereditary immunodeficiency;
- 另有 7 项未显示
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