Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP)

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Physicians	PRFs	A sample of 230 to 325 rheumatologists actively involved in management and treatment decisions of pSS subjects in France, Italy, Spain, Germany and the United States will be included in the survey.
Subjects with pSS	PSC questionnaire	Subjects with a confirmed diagnosis of pSS under consultation of the rheumatologists enrolled in the study will be included.
Physicians	Interview	A sample of 230 to 325 rheumatologists actively involved in management and treatment decisions of pSS subjects in France, Italy, Spain, Germany and the United States will be included in the survey.

Primary Outcome Measures

Name	Time	Method
Physician reported categorization of pSS subjects	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	Baseline	Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.

Secondary Outcome Measures

Name	Time	Method
Description of subject's journey	As reported	Summary of subject's journeys from diagnosis to current management and treatment, including an overview of HCRU.
Drivers of physician and subject reported satisfaction	Baseline	Data for drivers of physician and subjects reported satisfaction with disease activity control and symptomatic relief will be derived.
Level of concordance/discordance between physician and patient reported satisfaction	Baseline	Data for discordance/concordance between physicians and subjects across key measures will be derived.
Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective	As reported / Baseline	Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective will be described.
Physician experience of biologic therapy	Baseline	Physicians' experience of biologic therapy, and attitudes towards biologic therapy for subjects with pSS will be described.
Physician perception of treatment targets	Baseline	Physicians' perceptions of treatment targets in pSS will be described.
subjects attitude towards route of administration	Baseline	Proportion of subjects willing to take medication by type of administration route (oral/tablet, subcutaneous injection, intravenously) will be described.

Locations (1): Adelphi Real World Investigational Site
🇬🇧
Cheshire, United Kingdom