Patient Phenotypes and Treatment Pathways in Primary Sjogren's Syndrome: an International Cross-sectional Survey of Rheumatologists and Adult Primary Sjögren's Syndrome Patients With Systemic Involvement (Adelphi 2018 pSS Disease Specific Programme)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,223
- 试验地点
- 1
- 主要终点
- Physician reported categorization of pSS subjects
研究概览
简要总结
Sjogren's Syndrome is a chronic autoimmune disease characterized by sicca (dryness) symptoms of the mouth and eyes. This autoimmune disease is less commonly studied and there are no licensed treatments to treat the underlying cause of disease and current management is based on clinical experience and/or small clinical studies. This study is based on DSP methodology, a multinational, cross-sectional, multi-sponsor survey of robust real-world data. DSP methodology collects quantitative market research data. The pSS DSP will survey a sample of approximately 230 to 325 rheumatologists and their prospectively consulting pSS subjects in France, Germany, Italy, Spain and the US. The data will be collected via physician interviews, physician workload questionnaires, detailed patient record forms (PRFs) to be completed by physicians, and a self-completion questionnaire by pSS subjects. The data collected using this method includes subjective and objective evidence, clinical information about individual patients, their disease and their treatment. This DSP will follow three key phases: preparatory phase, data collection phase and data processing/analysis phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician eligibility criteria:
- •Primary physician specialty identified as Rheumatologist
- •Physicians who currently treat 7 or more pSS subjects in a typical month
- •Physicians who are actively involved in the management and treatment decisions of pSS subjects
- •Subject eligibility criteria:
- •Subjects with a diagnosis of Sjogren's syndrome in the opinion of the rheumatologist in the absence of Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) or Systemic Sclerosis.
- •For main sample (6 subjects per rheumatologist)
- •Subjects with age >=18 years and with confirmed diagnosis of pSS and are currently, or have previously, exhibited disease activity in one or more of the categories: fever of non-infectious origin, lymphadenopathy/lymphoma, glandular swelling/enlarged parotid gland, arthralgia/synovitis, erythema/vasculitis/purpura, pulmonary involvement, renal involvement, myositis, peripheral nervous system involvement, central nervous system involvement, cytopenia of autoimmune origin (with neutropenia) and/or anemia and/or thrombocytopenia and/or lymphopenia, hypocomplementemia and/or hypergammaglobulinemia and/or cryoglobulinemia or hypogammaglobulinemia and/or Ever received immunosuppressant or biologic treatment.
- •For oversample (1 subject per rheumatologist)
- •Subjects with age >=18 years and with confirmed diagnosis of pSS that fit the following criteria: Has never exhibited disease activity in any of the categories above, Moderate or severe fatigue (in the opinion of the rheumatologist)
排除标准
- •Not applicable
结局指标
主要结局
Physician reported categorization of pSS subjects
时间窗: Baseline
The most common categorization of pSS subjects by rheumatologists will be described, alongside differences in humanistic and clinical burden of these categories.
Statistically derived clusters of pSS subjects
时间窗: Baseline
Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.
次要结局
- Description of subject's journey(As reported)
- Drivers of physician and subject reported satisfaction(Baseline)
- Level of concordance/discordance between physician and patient reported satisfaction(Baseline)
- Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective(As reported / Baseline)
- Physician experience of biologic therapy(Baseline)
- Physician perception of treatment targets(Baseline)
- subjects attitude towards route of administration(Baseline)