EUCTR2012-000444-10-DE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
- 43
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
- •Part 1 and Part 2:
- •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)
- •sJIA symptoms lasting for at least 1 month since diagnosis of sJIA
- •For female patients of reproductive potential: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of TCZ
- •For male patients of reproductive potential: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of TCZ
- •Patients entering Part 1 who are naïve to TCZ therapy must also meet the following inclusion criterion:
- •History of inadequate clinical response (in the opinion of the treating physician) to NSAIDs and corticosteroids
- •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.
- •All patients entering Part 2 (either directly without participating in Part 1, or via Part 1) must meet the following additional criteria for entry into Part 2:
- •JADAS-71 score of 3.8 or less and absence of fever (related to sJIA) at screening and baseline.
- •Neutropenia, thrombocytopenia, or elevated ALT/AST (as per defined criteria) previously experienced (and resolved) on the labeled dose (Q2W) of TCZ at any time.
- •Laboratory Abnormalities Serving as Inclusion Criteria for Part 2 When Experienced (with Resolution) on Q2W TCZ
- •Abnormality Results Range
- •Neutropenia ANC 0.5 to 1.0 X 10 to the 9/L
- •Thrombocytopenia Platelets 50 to 100 X 10 to the 9/L
- •Elevated liver enzymes ALT/AST > 1 to 3 x ULN
- •TCZ=tocilizumab; ULN=upper limit of normal.
- •Not currently receiving oral corticosteroids, or taking oral corticosteroids at a stable dose for a minimum of 2 weeks prior to the part 2 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 part 2 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: 71
- •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
- •Wheelchair bound or bedridden
- •Lack of peripheral venous access.
- •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 Part 1 and the initial 12 weeks of Part 2 of the study (for patients entering Part 1) or the initial 12 weeks of Part 2 of the study (for patients entering Part 2 without participating in Part 1).
- •Any significant concurrent medical or surgical condition which would jeopardize the patient’s safety or ability to complete the trial.
- •Pregnant, lactating, or intending to become pregnant during study conduct and up to 6 months after the last administration of study drug.
- •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:
- •a) Acute or chronic renal / bladder infections
- •b) 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
- •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
- •Significant cardiac [e.g., congenital heart disease, valvular heart disease, constrictive pericarditis (unrelated to sJIA), myocarditis] or pulmonary disease, (e.g., 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, cystic fibrosis)
- •History of or current cancer or lymphoma
- •Uncontrolled diabetes mellitus with elevated hemoglobin (Hgb) A1c as defined by age-specific standards.
- •History of 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.
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