Clinical trial NCT03501420: Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP)
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sjogren's Syndrome
Keywords: Belimumab
Disease Specific Programme
rheumatologist
Benlysta
Primary Sjögren's Syndrome
Adelphi pSS DSP
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Adelphi Real World
First posted: 2018-04-18
Enrollment: 2223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Physician reported categorization of pSS subjects
timeFrame: Baseline
measure: Statistically derived clusters of pSS subjects
timeFrame: Baseline
Secondary outcomes:
measure: Description of subject's journey
timeFrame: As reported
measure: Drivers of physician and subject reported satisfaction
timeFrame: Baseline
measure: Level of concordance/discordance between physician and patient reported satisfaction
timeFrame: Baseline
measure: Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective
timeFrame: As reported / Baseline
measure: Physician experience of biologic therapy
timeFrame: Baseline
measure: Physician perception of treatment targets
timeFrame: Baseline
measure: subjects attitude towards route of administration
timeFrame: Baseline
Other outcomes:
Locations:
city: Cheshire
country: United Kingdom
facility: Adelphi Real World Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: