An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 20
- 主要终点
- Part A: Percentage of Responders for Baricitinib at Week 24
研究概览
简要总结
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.
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
- 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
- •Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features.
- •Participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (MTX).
- •Participants must have an inadequate response or intolerance to MTX.
- •Participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening.
- •Participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product.
排除标准
- •Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis.
- •Participants must not have any contraindications to adalimumab.
- •Exception: Participants who are biologic disease-modifying antirheumatic drug (bDMARD) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib.
- •Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant.
- •Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy).
- •Participants must not have a current or recent (<4 weeks prior to baseline) infection.
- •Participants must not have a positive test for hepatitis B virus (HBV) at screening.
- •Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.
研究组 & 干预措施
Baricitinib
Participants ≥9 to <18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants <9 years of age were administered 2 mg baricitinib QD.
Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets.
干预措施: Baricitinib (Drug)
Adalimumab
Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing <30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Part A: Percentage of Responders for Baricitinib at Week 24
时间窗: Week 24
Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.
次要结局
- Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye(Baseline, Week 24)
- Change From Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)(Baseline, Week 24)
- Percentage of Responders in Participants With Bilateral Uveitis Disease at Baseline(Week 24)
- Change From Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test(Baseline, Week 24)
- Time to Inactive Anterior Uveitis Disease (Using SUN Definition)(Baseline through Week 24)
- Percentage of Participants Who Are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day(Week 24)
- Change From Baseline in Vitreous Haze(Baseline, Week 24)
- Change From Baseline in Grade of Flare in the Anterior Chamber(Baseline, Week 24)
- Percentage of Participants With Inactive Anterior Uveitis (Using SUN Definition)(Week 24)
- Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants With JIA-U)(Week 24)
- Change From Baseline in Overall Uveitis-Related Disability(Baseline, Week 24)