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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Sjogren's Syndrome

Treatments: Other: Interview; Other: PSC questionnaire; Other: PRFs

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03501420

207382

Details and patient eligibility

About

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.

Enrollment: 2,223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,223 participants in 2 patient groups

Physicians

Description:

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.

Treatment:

Other: Interview

Other: PRFs

Subjects with pSS

Description:

Subjects with a confirmed diagnosis of pSS under consultation of the rheumatologists enrolled in the study will be included.

Treatment:

Other: PSC questionnaire