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)

Sponsoren

Hauptsponsor: GlaxoSmithKline

Mitarbeiter: Adelphi Real World

Quelle GlaxoSmithKline
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum June 13, 2018
Fertigstellungstermin October 30, 2018
Primäres Abschlussdatum October 30, 2018
Studientyp Observational
Primärer Ausgang
Messen Zeitfenster
Physician reported categorization of pSS subjects Baseline
Statistically derived clusters of pSS subjects Baseline
Sekundäres Ergebnis
Messen Zeitfenster
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
Physician perception of treatment targets Baseline
subjects attitude towards route of administration Baseline
Einschreibung 2223
Bedingung
Intervention

Interventionsart: Other

Interventionsname: Interview

Beschreibung: 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

Armgruppenetikett: Physicians

Interventionsart: Other

Interventionsname: PSC questionnaire

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

Armgruppenetikett: Subjects with pSS

Interventionsart: Other

Interventionsname: PRFs

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

Armgruppenetikett: Physicians

Teilnahmeberechtigung

Probenahmeverfahren: Non-Probability Sample

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Insgesamt offiziell
Ort
Einrichtung: Adelphi Real World Investigational Site
Standort Länder

United Kingdom

Überprüfungsdatum

January 2019

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Armgruppe

Etikette: Physicians

Beschreibung: 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.

Etikette: Subjects with pSS

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

Studiendesign Info

Beobachtungsmodell: Cohort

Zeitperspektive: Cross-Sectional

Quelle: ClinicalTrials.gov