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

 -  Not applicable