Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 62
- 主要终点
- Juvenile Spondyloarthritis (JSpA) flare
研究概览
简要总结
This randomized pragmatic trial will generate knowledge about strategies used to de-escalate tumor necrosis factor inhibitor (TNFi) therapy in patients with juvenile spondyloarthritis with sustained inactive disease and are treated at one of the 31 participating pediatric healthcare systems. This open label study will be conducted in the setting of routine clinical care and will compare the risk and timing of flare (Aim 1) and patients' lived experiences (Aim 2) across three arms.
详细描述
This project is a prospective, 12-month pragmatic randomized trial embedded within routine clinical care. Children with spondyloarthritis who have maintained inactive disease on a clinically prescribed standard dosing of a TNFi for 6 months or longer will be eligible for enrollment. Children will be randomized to one of the following alternative approaches: continued fixed standard dosing (arm 1), fixed longer dosing intervals of TNFi (arm 2), or stopping TNFi (arm 3). The recommended visit frequency is every 3 months through the study endpoint at 12 months. After subjects have followed their treatment assignment for 12 months, those who have not flared may modify their treatment regimen as per shared decision making between themselves and the treating physician. All participants will be monitored for 24 additional months for long-term outcomes after the intervention period.
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
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females age 8 to 21 years
- •Juvenile SpA diagnosis:
- •Symptom onset before their 16th birthday:
- •o International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis enthesitis-related arthritis subtype
- •Symptom onset before their 18th birthday:
- •o Pediatric Rheumatology International Trials Organization (PRINTO) revision of the ILAR criteria enthesitis spondylitis-related JIA
- •Peripheral arthritis and enthesitis, or
- •Arthritis or enthesitis, plus ≥3 months of inflammatory back pain and sacroiliitis on imaging, or
- •Arthritis or enthesitis plus 2 of the following: (1) sacroiliac joint tenderness; (2) inflammatory back pain; (3) presence of HLA-B27 antigen; (4) acute (symptomatic) anterior uveitis; and (5) history of a SpA in a first-degree relative.
- •If peripheral arthritis is present, it should persist for at least 6 weeks.
- •Currently taking one of the following TNFi therapies (Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab, or TNFi biosimilar) at standard doses
- •Have reached a clinically inactive disease state for a minimum of six months, as determined by treating physician
- •English speaking or Spanish speaking
- •Subject's treating physician recommended that he/she is a good candidate to participate in the study, which may include a modified therapy
- •Interested and willing to de-escalate TNFi therapy
排除标准
- •1) History of inflammatory bowel disease, history of uveitis that was not adequately controlled with localized ophthalmic treatment or psoriasis that pre-dates the start of TNFi therapy or psoriasis that started after TNFi therapy and has required more than topical therapy for control
研究组 & 干预措施
TNFi Therapy Withdrawal
Stop TNFi treatment
干预措施: Stop TNFi treatment (Other)
TNFi Standard Therapy
Continue fixed standard treatment (i.e., no change from current therapy)
干预措施: Standard TNFi Therapy (Other)
TNFi fixed longer dosing intervals
Fixed longer dosing intervals of TNFi (i.e., increased time between doses)
干预措施: TNFi fixed longer dosing intervals (Other)
结局指标
主要结局
Juvenile Spondyloarthritis (JSpA) flare
时间窗: 12 months
JSpA flare is defined as clinically meaningful worsening in ≥3 of the following: caregiver/patient assessment of well-being, physician assessment of disease activity, caregiver/patient assessment of pain, physical function, and active joint count. Meaningful change for well-being, disease activity, and pain are an increase of ≥2 on visual analogue scale (range 0-10 with higher scores indicating poorer well-being, higher disease activity, and higher magnitude of pain). Meaningful change in function is defined as ≥3 unit change in the PROMIS mobility or upper extremity T-scores. The Patient-Reported Outcomes Measurement Information System (PROMIS) short forms include 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation of 10. Active joint count is defined as the number of joints with swelling or, in the absence of swelling, limitation of motion accompanied by pain or warmth as per the physician examination.
次要结局
- Pain interference (as measured by the PROMIS short form)(12 months)