EUCTR2015-000435-33-DE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)
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
- •- sJIA symptoms for at least 1 month subsequent to diagnosis of sJIA
- •- 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, which may include the presence or absence of fever (>=38°C) during the time between screening and baseline; or >=2 active joints at screening and baseline, with a fever >=38°C for at least 5 consecutive days during the time between 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 (together with either folic acid or folinic acid according to local standard-of-care), 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
- •- If the patient has received previous treatment with any of the following biologic agents, these must have been discontinued according to the following timelines prior to the baseline visit and are not permitted during the study:
- •Etanercept must have been discontinued within = 2 weeks prior to baseline
- •Anakinra must have been discontinued within = 4 days prior to baseline
- •Abatacept must have been discontinued within = 12 weeks prior to baseline
- •Infliximab or adalimumab must have been discontinued within = 8 weeks prior to baseline
- •Canakinumab must have been discontinued within = 20 weeks prior to baseline
- •Rilonacept must have been discontinued within = 6 weeks prior to baseline
- •Golimumab must have been discontinued within = 10 weeks prior to baseline
- •Certrolizumab pegol must have been discontinued within = 10 weeks prior to baseline
- •- History of inadequate clinical response (in the opinion of the treating physician) to NSAIDs and corticosteroids
- •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 (except for myringotomy surgery, which is permitted)
- •- History of significant allergic or infusion reactions to prior biologic therapy or to any of the excipients listed in TCZ product labelling documents;
- •- Inborn conditions characterized by a compromised immune system
- •- Known HIV infection or other acquired forms of immune compromise
- •- 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 within 6 months of screening visit consistent with local practice
- •- 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
- •- History of hepatitis B or hepatitis C infection
- •- Chronic hepatitis – viral or autoimmune
- •- 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 3 months prior to the screening visit
- •- Participation in another interventional clinical trial within the past thirty days or five serum half-lives of the investigative medication, whichever is longer;
- •- Previous treatment with TCZ
- •- 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
- •- Uncontrolled diabetes mellitus with elevated hemoglobin (Hgb) A1c as defined by age-specific standards
- •- Laboratory Exclusions at Screening:
- •Serum creatinine >1.5 ULN (upper limit of normal for age and sex);
- •AST or ALT > 1.5 ULN (upper limit of normal for age and sex);
- •Total bilirubin > 1.3 mg/dL (> 23 umol/L);
- •Platelet count < 200 x103/µL (< 200,000/mm3);
- •Hemoglobin < 7.0 g/dL (< 4.3 mmol/L);
- •WBC count < 6,200/mm3 (< 6.2 x 109/L);
- •Neutrophil count < 2,500/ mm3 (< 2.5x 109/L)
研究者
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