EUCTR2015-000435-33-HU进行中（未招募）1 期
A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- •- Age less than 24 months at baseline
- •- Fulfills International League of Associations for Rheumatology classification criteria for sJIA
- •- Duration of sJIA lasting at least 1 month since onset of sJIA symptoms
- •- Presence of active disease as determined by the presence of >=2 active joints at screening and baseline, with at least 14 consecutive days of temperature recordings to identify presence or absence of fever (>=38°C) during screening and baseline; or >=2 active joints at screening and baseline, with a fever >=38°C for at least 5 consecutive days during screening and baseline; under these circumstances a patient does not need to complete a full 14 days of temperature diary entries to meet this inclusion criteria
- •- Not currently receiving corticosteroids (CS) OR if taking oral CS, receiving prednisone or equivalent at a stable dose of <=1 milligrams per kilograms per day (mg/kg/day); and the dose remained stable for at least 2 weeks prior to baseline
- •- Not currently receiving methotrexate (MTX) OR if taking MTX, the dose has remained stable or has been discontinued for at least 4 weeks prior to baseline
- •- Not currently receiving non-steroidal anti-inflammatory drug (NSAID) OR if taking NSAID, the dose has remained stable or has been discontinued for at least 2 weeks prior to baseline
- •- Never treated with biologics except anakinra which has been discontinued >=1 week prior to the baseline visit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any other auto-immune, rheumatic disease or overlap syndrome other than sJIA
- •- Any significant concurrent medical or surgical condition which would jeopardize the patient’s safety or ability to complete the trial or planned surgery during the study (myringotomy surgery does not exclude patient)
- •- Evidence of serious uncontrolled concomitant diseases including but not limited to the nervous system, renal, hepatic, or endocrine systems
- •- Asthma for which the patient has required the use of oral or parenteral corticosteroids for >=2 weeks within 6 months prior to the baseline visit
- •- Any active acute, subacute, chronic or recurrent bacterial, viral, or systemic fungal infection including but not limited to: acute or chronic renal / bladder infections; acute or chronic pulmonary infections
- •- History of atypical tuberculosis (TB) and active TB requiring treatment at any point prior to screening visit and positive TB test result at screen, unless treated with anti-tuberculosis therapy for at least 4 weeks prior to receiving study medication and chest radiograph is negative for active tuberculosis
- •- Any major episode of infection requiring hospitalization or treatment during screening or treatment with intravenous antibiotics completing within 4 weeks of the screening visit or oral antibiotics completing within 2 weeks of the screening visit
- •- History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein Barr virus within 2 months of the screening visit
- •- Significant cardiac or pulmonary disease
- •- History or concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, ulcerative colitis or other symptomatic lower gastrointestinal conditions, including ulcer and perforation;
- •- History of or current cancer or lymphoma
- •- History of macrophage activation syndrome within 1 month prior to the screening visit
- •- Administration of intravenous immunoglobulin within 4 weeks prior to the baseline visit
- •- Previous treatment with any cell depleting therapies, including investigational agents (e.g. anti-CD19 and anti-CD20)
- •- Prior stem cell transplant at any time
- •- Live or attenuated vaccines within 4 weeks prior to the baseline visit, or intending to receive while on study medication or 8 weeks following the last dose of study medication
研究者
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