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Completed

NCT Number: NCT03501420

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adelphi Real World Investigational Site

Cheshire, SK10 5JB, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

PRFs

Other

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

Primary outcomes

  1. Physician reported categorization of pSS subjects

    Time frame: Baseline

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

  2. Statistically derived clusters of pSS subjects

    Time frame: Baseline

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

Secondary outcomes

  1. Description of subject's journey

    Time frame: As reported

    Summary of subject's journeys from diagnosis to current management and treatment, including an overview of HCRU.

  2. Drivers of physician and subject reported satisfaction

    Time frame: Baseline

    Data for drivers of physician and subjects reported satisfaction with disease activity control and symptomatic relief will be derived.

  3. Level of concordance/discordance between physician and patient reported satisfaction

    Time frame: Baseline

    Data for discordance/concordance between physicians and subjects across key measures will be derived.

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

    Time frame: As reported / Baseline

    Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective will be described.

  5. Physician experience of biologic therapy

    Time frame: Baseline

    Physicians' experience of biologic therapy, and attitudes towards biologic therapy for subjects with pSS will be described.

  6. Physician perception of treatment targets

    Time frame: Baseline

    Physicians' perceptions of treatment targets in pSS will be described.

  7. subjects attitude towards route of administration

    Time frame: Baseline

    Proportion of subjects willing to take medication by type of administration route (oral/tablet, subcutaneous injection, intravenously) will be described.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Adelphi Real World

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2018
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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