Adalimumab Dose Adjustment for Pediatric Uveitis Treatment Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 18
- 主要终点
- Cumulative Incidence of Treatment Failure
研究概览
简要总结
The goal of this clinical trial is to learn whether children and young adults with well-controlled juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior uveitis can safely take adalimumab (or biosimilar) injections less often while maintaining control of their disease.
The main question it aims to answer is: can adalimumab/biosimilar injections be given less frequently without uveitis (eye inflammation) or arthritis (joint inflammation) returning?
Researchers will compare adalimumab/biosimilar injection schedules of every 2 weeks, 4 weeks, 8 weeks, and 12 weeks to determine how injection frequency affects disease control.
Participants will:
- Take adalimumab/biosimilar injections every 2, 4, 8, or 12 weeks.
- Attend study visits every 6 weeks over 24 weeks, with an additional follow-up visit at 48 weeks for checkups, tests, and questionnaires.
- Keep a diary of how often they take adalimumab/biosimilar and other drugs they take for their uveitis/arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stated willingness to comply with all study procedures and availability for the duration of the study period
- •History of juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU), diagnosed prior to 16 years of age (patient may be older than 16 at time of enrollment)
- •≥2 years of age (per FDA approval for use in children with polyarticular JIA)
- •Weight must be ≥15kg
- •Formal diagnosis of JIA-associated uveitis or CAU with no other suspected etiology
- •≥24 consecutive months of controlled ocular inflammation (≤0.5+ anterior chamber cell, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions in either eye)
- •≥24 consecutive months of controlled arthritis verified by a pediatric rheumatologist if defined as JIA-associated uveitis
- •≥24 consecutive months of treatment with adalimumab or biosimilar of adalimumab
- •≥180 days on a stable dose of adalimumab or biosimilar of adalimumab; dose must be no greater than 20mg (if weight <30kg), or 40mg (if weight ≥30kg), injected every two weeks
- •If on biosimilar of adalimumab, ≥90 days on the biosimilar
- •Ability to continue to obtain commercial supply of adalimumab or biosimilar
- •If on a conventional disease-modifying anti-rheumatic drug (cDMARD) (injectable or oral methotrexate, mycophenolate mofetil, azathioprine, or leflunomide), dose must be ≤25 mg weekly for methotrexate, ≤3 g daily for mycophenolate mofetil, ≤250 mg daily for azathioprine, or ≤20 mg daily for leflunomide; dose and route of administration must be stable for ≥90 days
- •Willingness to limit consumption of alcohol during the study period
- •Agreement to avoid live attenuated vaccinations
- •Agreement to use highly effective contraception or abstinence for ≥28 days prior to screening and throughout the study period (for males and females of reproductive age)
- •Suitable, in the opinion of the Investigator, to continue treatment with adalimumab/biosimilar per regional labeling
排除标准
- •History of acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity
- •Intraocular surgery in the past 90 days or planned surgery in the next 24 weeks
- •Severe cataract or opacity preventing view to the posterior pole in both eyes
- •Chronic hypotony (<5mmHg for ≥90 days) in either eye
- •Treatment with oral corticosteroids or intraocular corticosteroid injection within the last 24 weeks
- •Use of topical corticosteroid eye drops within the last 90 days
- •Use of nonsteroidal anti-inflammatory drug (NSAID) eye drops within the last 90 days
- •Pregnancy or lactation (a pregnancy test will be conducted at baseline and follow-up visits for females post-menarche)
- •Presence of intraretinal or subretinal fluid in either eye
- •Prior safety or tolerability issues with adalimumab
- •History of cancer, active tuberculosis, or hepatitis B
- •Other medical condition expected to dictate treatment course during the study
- •Any of the following laboratory test results on their most recent tests within the past 90 days prior to screening/enrollment: leukocyte count <2500, platelet count ≤75000, hemoglobin<9.0, aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5
研究组 & 干预措施
2-Week Dose
Participants receive adalimumab/biosimilar at their current weight-based dose every 2 weeks for 24 weeks, continuing in accordance with current standard of care practice.
干预措施: Adalimumab/Biosimilar (Biological)
4-Week Dose
Participants receive adalimumab/biosimilar at their current weight-based dose every 4 weeks for 24 weeks.
干预措施: Adalimumab/Biosimilar (Biological)
8-Week Dose
Participants receive adalimumab/biosimilar at their current weight-based dose every 8 weeks for 24 weeks.
干预措施: Adalimumab/Biosimilar (Biological)
12-Week Dose
Participants receive adalimumab/biosimilar at their current weight-based dose every 12 weeks for 24 weeks.
干预措施: Adalimumab/Biosimilar (Biological)
结局指标
主要结局
Cumulative Incidence of Treatment Failure
时间窗: From baseline to 24 weeks post-randomization
Proportion of participants in each treatment arm experiencing treatment failure by Week 24. Treatment failure is defined by recurrence of ocular inflammation (at least one of the following in at least one eye): * \>0.5+ anterior chamber (AC) cell at a single visit as defined by the Standardization of Uveitis Nomenclature (SUN) criteria * \>0.5+ vitreous haze at a single visit * Active retinal/choroidal inflammation and/or macular edema in either eye at a single visit. Macular edema is defined as central subfield thickness on optical coherence tomography (OCT) \>2 standard deviations above normal thickness (\>320µm on Spectralis or \>300µm on Zeiss or Topcon) and having a greater than 20% increase from baseline and/or presence of intraretinal or subretinal fluid. Treatment failure may also be defined as recurrence of joint disease persistent and severe enough to necessitate unmasking to manage the arthritis recurrence.
次要结局
未报告次要终点
研究者
Nisha Acharya
Principal Investigator
University of California, San Francisco