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

NCT03501420 | Completed

• 1 other identifier: 207382
• Study Type: observational
• Target: 2,223
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome

Keywords

Belimumab; Disease Specific Programme; rheumatologist; Benlysta; Primary Sjögren's Syndrome; Adelphi pSS DSP

Outcome Measures

Primary Outcomes (2)

• Physician reported categorization of pSS subjects

  The most common categorization of pSS subjects by rheumatologists will be described, alongside differences in humanistic and clinical burden of these categories.

  Baseline

• Statistically derived clusters of pSS subjects

  Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.

  Baseline

Secondary Outcomes (7)

• Description of subject's journey

  As reported

• Drivers of physician and subject reported satisfaction

  Baseline

• Level of concordance/discordance between physician and patient reported satisfaction

  Baseline

• Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective

  As reported / Baseline

• Physician experience of biologic therapy

  Baseline

Study Arms (2)

Physicians

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.

Other: Interview; Other: PRFs

Subjects with pSS

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

Other: PSC questionnaire

Interventions

Interview OTHER

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

Physicians

PSC questionnaire OTHER

All subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation.

Subjects with pSS

PRFs OTHER

PRFs will be completed by the physicians for seven of their consulting pSS subjects.

Physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 230-325 rheumatologists actively involved in management and treatment decisions of pSS subjects in France, Italy, Spain, Germany and the United States and their prospectively consulting subjects with a confirmed diagnosis of pSS will be included in the DSP.

You may qualify if:

• 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)

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Adelphi Real World: collaborator

Study Sites (1)

Adelphi Real World Investigational Site

Cheshire, SK10 5JB, United Kingdom

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: June 13, 2018
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

GB (1)