NCT03501420

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,223 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
OTHER	Interview	A one hour survey interview will be completed by the rheumatologists which will contain open and closed questions to probe physician perception and behaviors in relation to pSS management and treatment
OTHER	PSC questionnaire	All subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation.
OTHER	PRFs	PRFs will be completed by the physicians for seven of their consulting pSS subjects.

Timeline

• Start date: 2018-06-13
• Primary completion: 2018-10-30
• Completion: 2018-10-30
• First posted: 2018-04-18
• Last updated: 2019-01-23

Locations

1 site across 1 country: United Kingdom