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

NCT03501420 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2223

Last updated 2019-01-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-13
Primary Completion
2018-10-30
Completion
2018-10-30

Countries

  • United Kingdom

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03501420 on ClinicalTrials.gov