EUCTR2012-000444-10-IT进行中（未招募）1 期
A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
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 2 years up to and including 17 years at screening into trial • sJIA according to International League of Associations for Rheumatology (ILAR) classification (2001) • JADAS-71 score of 3.8 or less and absence of fever (related to sJIA) at screening and baseline (Consolaro et al. 2012) • Neutropenia, thrombocytopenia, or elevated ALT/AST (as per defined criteria) previously experienced (and resolved) on the labeled dose (Q2W) of TCZ at any time • Must meet one of the following: Not receiving MTX or discontinued MTX at least 4 weeks prior to baseline visit, or taking MTX for at least 12 weeks immediately prior to the baseline visit and on a stable dose of =20 mg/m2 for at least 8 weeks prior to the baseline visit, together with either folic acid or folinic acid according to local standard of care • Not currently receiving oral corticosteroids, or taking oral corticosteroids at a stable dose for a minimum of 2 weeks prior to the baseline visit at no more than 10 mg/day or 0.2 mg/kg/day, whichever is less • Not taking NSAIDs, or taking no more than 1 type of NSAID at a stable dose for a minimum of 2 weeks prior to the baseline visit, with the dose being less than or equal to the maximum recommended daily dose
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •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
- •GENERAL: Wheelchair bound or bedridden. Any other auto-immune, rheumatic disease, or overlap syndrome other than sJIA. Not fully recovered from recent surgery or less than 6 weeks since surgery, at the time of screening visit; or planned surgery during the initial 12 weeks of the study. Lack of peripheral venous access. GENERAL SAFETY:Pregnant, lactating, or intending to become pregnant during study conduct and up to 12 weeks after the last administration of study drug. Any significant concurrent medical or surgical condition which would jeopardize the patient’s safety or ability to complete the trial. History of significant allergic or infusion reactions to prior TCZ infusion, and/or presence of anti-TCZ antibodies by confirmatory and/or neutralizing assay at screening. Inborn conditions characterized by a compromised immune system. Known HIV infection or other acquired forms of immune compromise. History of alcohol, drug, or chemical abuse within 6 months of screening. Evidence of serious uncontrolled concomitant diseases, including but not limited to the nervous, renal, hepatic, or endocrine systems. Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection including but not limited to: acute or chronic renal / bladder infections and acute or chronic pulmonary infections. History of atypical tuberculosis (TB). Active TB requiring treatment within 2 years prior to the screening visit. Positive purified protein derivative (PPD) at screen (or equivalent result based on local methodology, e.g., Quantiferon gold), unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice. Any major episode of infection requiring hospitalization or treatment during screening or treatment with IV 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. Hepatitis B surface Antigen or hepatitis C Ab positive. Chronic hepatitis – viral or autoimmune. Significant cardiac or pulmonary disease. History or concurrent serious gastrointestinal (GI) disorders, such as ulcer or inflammatory bowel disease, Crohn’s disease, ulcerative colitis, or other symptomatic lower GI conditions, including ulcer and perforation. History of or current cancer or lymphoma. Uncontrolled diabetes mellitus with elevated Hgb A1c as defined by age-specific standards. History of macrophage activation syndrome (MAS) within 3 months prior to the screening visit. EXCLUDED PREVIOUS or CONCOMITANT THERAPY: Participation in another interventional clinical trial within the past 30 days or 5 serum half-lives of the investigative medication or the PD effect of the investigative medication, whichever is longer. Prior stem cell transplant at any time. Prohibited therapy as described in Section 4.3.2 of the protocol. LABORATORY EXCLUSIONS AT SCREENING: Serum creatinine > 1.5 x upper limit of normal (ULN) (for age and sex). Hemoglobin < 7.0 g/dL (<4.3 mmol/L)
研究者
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