EUCTR2019-000412-29-GB进行中（未招募）1 期
Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST) - ADJUST
F.I. Proctor Foundation, University of California San Francisco0 个研究点目标入组 118 人开始时间: 2019年3月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 118
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
- •Stated willingness to comply with all study procedures and availability for the duration of the study period
- •History of JIA diagnosed prior to 16 years of age
- •2 year of age or older
- •Formal diagnosis of JIA-associated uveitis with no other suspected etiology
- •=12 consecutive months of controlled ocular inflammation (=0.5+ AC cell, =0.5+ vitreous haze, and no active retinal/choroidal lesions in either eye or macular edema)
- •= 12 consecutive months of controlled arthritis verified by a pediatric rheumatologist (see definition of controlled arthritis in Table 2)
- •=12 consecutive months with adalimumab or a biosimilar
- •=180 days on a stable dose of adalimumab or a biosimilar; must be a biweekly dose of no greater than 20 mg (if< 30kg) or 40 mg (if =30kg)
- •If on a biosimilar of adalimumab, =90 days on biosimilar
- •If on concomitant injectable or oral methotrexate or mycophenolate mofetil, dose must be =25 mg weekly for methotrexate or =3 g daily for mycophenolate mofetil and stable for =90 days
- •If on topical corticosteroids, dose must be =2 drops prednisolone acetate 1% or equivalent per day and stable for =90 days
- •Willingness to limit consumption of alcohol during the study period
- •Agreement to avoid live attenuated vaccinations
- •Agreement to use effective contraception or abstinence for =28 days prior to screening and throughout study period (for patients of reproductive age)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Intraocular surgery in the past 90 days or planned surgery in the next 180 days
- •Severe cataract or opacity preventing view to the posterior pole in both eyes
- •Acute or recurrent anterior uveitis characterized by redness and symptoms, including but not limited to: floaters, light sensitivity, pain
- •Chronic hypotony (< 5 mmHg for =90 days) in either eye
- •Treatment with oral corticosteroids or intraocular corticosteroid injections within the last 12 months
- •Acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity
- •Pregnancy or lactation (a pregnancy test will be conducted at baseline and all follow-up visits for females of reproductive age)
- •Prior safety or tolerability issues with adalimumab
- •History of cancer, tuberculosis, or hepatitis B
- •Other medical condition expected to dictate treatment course during the study
- •Any of the following abnormal lab values within 28 days prior to enrollment: leukocyte count < 2500, platelet count =75000, hemoglobin< 9.0, AST (SGOT) or ALT (SGPT) = 2 times the upper limit of normal range, creatinine =1.5
研究者
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