NCT01603355终止1 期
An Open-label Trial to Assess the Efficacy and Safety of Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression
Eric B. Suhler1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants With Control of Ocular Inflammation
研究概览
简要总结
The investigators are doing this research study to see if tocilizumab (Actemra) is safe and effective when used for severe or refractory non-infectious uveitis. Uveitis is an inflammation of the eye that is caused by the body's immune system reacting against the eye tissues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Juvenile Idiopathic Arthritis
- •Subjects with vision-threatening autoimmune uveitis.
- •Failure to respond to methotrexate or at least one other systemic immunosuppressive or intolerance to such medications due to side effects. Failure to respond includes presence of one plus or greater anterior chamber cell in both eyes; need for topical corticosteroid four times or more in either eye; ocular hypertension or glaucoma attributable to the topical corticosteroid.
- •Subjects with bilateral disease.
- •If subjects are on oral corticosteroids, the dosage must be stable for 2 weeks prior to baseline and not exceed 10 mg per day or 2mg/kg/day (whichever is less) of prednisone or its equivalent. Subjects must be willing to agree to not alter the dosage of oral steroids during the first 16 weeks of the trial.
- •Must have a chest radiograph within 3 months prior to enrollment with no evidence of malignancy, infection or fibrosis.
- •Parent or guardian must understand and voluntarily sign an informed consent form.
- •Pediatric subjects of either gender 2-17 years at time of consent.
排除标准
- •Inability of parent or guardian to provide voluntary consent
- •Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 12 months following randomization.
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •Pregnant or breastfeeding
- •Current liver disease, as determined by the Principal Investigator on the basis of history or serum studies
- •History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies including tocilizumab.
- •Evidence of significant uncontrolled concomitant diseases such as nervous system, renal, hepatic (patients with prior history of ALT elevation will not be excluded), endocrine, or gastrointestinal (GI) disorders, which in the Investigator's opinion, would preclude patient participation.
- •Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.
- •Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- •History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 2 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 2 years prior to screening visit are allowed if successful treatment was completed at least 2 years prior to randomization and is documented and available for verification.
- •Immunization with a live/attenuated vaccine within 4 weeks prior to baseline
- •Latent Mycobacterium tuberculosis infection as indicated by a positive Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
- •If QuantiFERON® test is performed instead of the PPD test, only those with a negative QuantiFERON® test are allowed in the study.
- •History of incompletely treated Mycobacterium tuberculosis infection as indicated by
- •Subject's medical records documenting incomplete treatment for Mycobacterium tuberculosis
- •Subject's self-reported history of incomplete treatment for Mycobacterium tuberculosis
- •History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years) or recurrent viral, fungal, mycobacterial, or other infections (including but not limited to atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
- •Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
- •Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
- •History of congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency [CVID])
- •Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening
- •History of Human Immunodeficiency Virus (HIV) infection
- •Antibodies to Hepatitis C at screening
- •Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening)
- •Have multiple sclerosis or other central demyelinating disorder.
- •Presence of a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to enrollment).
- •History of substance abuse (drug or alcohol) within the previous 3 years, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the subject's adherence to protocol requirements.
- •Previous or current use of an alkylating agent (e.g. chlorambucil or cyclophosphamide).
- •Treatment with etoposide (VP16) within 3 months prior to the baseline visit.
- •Administration of intravenous immunoglobulin for the treatment of active polyarticular disease 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.
- •TNF -blocker use within the 8-weeks prior to enrollment (Infliximab use within 10 weeks prior to enrollment).
- •Laboratory Exclusion criteria (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 < 150 x 103/μL (< 150,000/mm3);
- •Hemoglobin < 9.0 g/dL (< 3.7 mmol/L);
- •WBC count < 5,000/mm3 (< 5.0 x 109/L);
- •Neutrophil count < 2,500/ mm3 (< 2.5 x 109/L)
研究组 & 干预措施
Tocilizumab
Experimental
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Number of Participants With Control of Ocular Inflammation
时间窗: 16 Weeks
control of anterior chamber cell in both eyes at week 16 to a level of trace or less (SUN criteria) without an increase in any immunosuppressive treatment and while using prednisolone acetate topically no more than 2 times per day
次要结局
未报告次要终点
研究者
Eric B. Suhler
Principal Investigator
Oregon Health and Science University
研究点 (1)
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