Effectiveness and Patient-reported Outcomes in Patients With Spondyloarthropathies Treated With Biological Agents
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ankylosing Spondylitis Disease Activity Index BASDAI 50 %
研究概览
简要总结
The objective of the study is to investigate extra-articular manifestations, pain mechanisms, patient-reported outcomes, comorbidities and association between these conditions in patients with spondyloarthropathy (SpA) treated with Biologics. Further, to assess the predictive value of baseline pain profile on treatment outcome after ≥ 3 months.
详细描述
Patients with spondyloarthropaty, who initiate or switch biologics in routine care due to an active disease state, will be enrolled in this observational study.
The overall aim is to investigate extra-articular manifestations, pain mechanisms and patient-reported outcomes and elucidate if these factors - independently or by interaction - influence treatment response after ≥ 3 months. Patients will have a baseline visit, an eye examination and a follow up visit after ≥ 3 months. Clinical examinations will be performed at both time points and include:
- Clinical examination (the spinal movement)
- Assessment of pain mechanisms by clinical evaluation (BASDAI, tender points,) and pain questionnaires (PainDETECT).
- The SPARCC Enthesitis Index will be used to enthesitis count.
- Interview and questionnaires regarding lifestyle, comorbidity, function and quality of life
- Blood samples
- Urine samples
- Stool samples
Clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of extra-articular manifestations, comorbidity and pain mechanisms will be analysed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with SpA
- •≥18 years of age at time of consent
- •Ability and willingness to give written informed consent and to meet the requirements of this protocol
- •Patients must have a history of active disease and a BASDAI >40 (10-100) or elevated C-reactive protein, despite current or previous NSAIDs therapy
排除标准
- •Age < 18 years
- •No consent
- •Pregnancy
- •Active or latent TB
- •Diagnosed Human immunodeficiency virus
- •Diagnosed hepatitis
- •Current or past malignant disease
- •Recurrent or chronic infection (viral, fungal or bacterial)
- •Multiple sclerosis
- •Heart failure (NYHA class III/IV)
结局指标
主要结局
Ankylosing Spondylitis Disease Activity Index BASDAI 50 %
时间窗: ≥ 3 month from baseline
composite measures of improvement in disease state (50% improvement)
次要结局
- Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)(≥ 3 month from baseline)
研究者
Rikke Asmussen Andreasen
MD
Svendborg Hospital