Treat and Train - A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6
研究概览
简要总结
This study is a non-interventional, longitudinal and non-confirmatory study to compare an active supervised training (AST) with standard of care (SOC) physiotherapy in patients with axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to health-related outcomes. The primary objective is the improvement in spinal mobility after a 6 month training program.
详细描述
Treatment of axSpA patients with adalimumab (HUMIRA®) was according to the local adalimumab product label and local standard of care. AxSpA patients who responded to newly initialized adalimumab treatment based on physicians' decision, and who were eligible for active physiotherapy were enrolled in the study. Although this was a non-interventional study, participants were randomly assigned to receive either active supervised and standardized training physiotherapy or standard of care physiotherapy in order to provide adequate numbers of participants in each comparison group.
Participants who consented to participate in the study were observed for up to 12 months from Baseline (defined as the Randomization visit where participants were assigned to one of the two physiotherapy options).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with axial spondyloarthritis (axSpA) (either ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA)), fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification, aged at least 18 years
- •Prescription of Humira® (adalimumab) for treating axSpA according to the local product label
- •Eligibility for active physiotherapy according to the rheumatologist and physiotherapist
- •Participants must have signed written informed consent before starting any study related assessments or procedures.
排除标准
- •Participants with total spinal ankylosis based on the investigators' assessments of available radiographs
- •Participants who are not eligible for active supervised training or active physiotherapy at the discretion of the rheumatologist and/or the physiotherapist
- •Participants with poorly controlled medical condition(s), which in the opinion of the investigator, would put the participant at risk by participation in the protocol
- •Any prior treatment with a biologic disease-modifying antirheumatic drugs (DMARD) is prohibited.
结局指标
主要结局
Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6
时间窗: Baseline and Month 6
BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis
次要结局
- Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)(Baseline and Month 3)
- Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline and Month 3)
- Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline and Month 3)
- Change From Baseline in Modified Work Ability Index (WAI)(Baseline and Month 3)
- Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3(Baseline and Month 3)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)(Baseline and Month 3)
- Percentage of Participants With ASDAS Inactive Disease(Month 3)
- Percentage of Participants With ASDAS Very High Disease Activity(Month 3)
- Percentage of Participants Achieving ASDAS Major Improvement(Baseline and Month 3)
- Percentage of Participants Achieving ASDAS Clinically Important Improvement(Baseline and Month 3)
- Change From Baseline in Patient's Assessment of Nocturnal Back Pain(Baseline and Month 3)
- Percentage of Participants Achieving a BASDAI 50 Response(Month 3)
- Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response(Baseline and Month 3)
- Change From Baseline in Patient's Assessment of Total Back Pain(Baseline and Month 3)
- Percentage of Participants With ASDAS Moderate Disease Activity(Month 3)
- Percentage of Participants Achieving ASAS Partial Remission(Month 3)
- Change From Baseline in Fatigue(Baseline and Month 3)
- Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ)(Baseline and Month 3)
- Percentage of Participants With ASDAS Low Disease Activity(Month 3)
- Percentage of Participants With ASDAS High Disease Activity(Month 3)
- Percentage of Participants Achieving an ASAS 40 Response(Baseline and Month 3)
- Change From Baseline in Patient's Global Assessment of Pain(Baseline and Month 3)
- Change From Baseline in Severity and Duration of Morning Stiffness(Baseline and Month 3)