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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT03501420

Collaborator

Adelphi Real World (Other)

2,223

Enrollment

Location

4.6

Actual Duration (Months)

486.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sjogren's Syndrome	Other: Interview Other: PSC questionnaire Other: PRFs

Study Design

Study Type:

Observational

Actual Enrollment :

2223 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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)

Actual Study Start Date :

Jun 13, 2018

Actual Primary Completion Date :

Oct 30, 2018

Actual Study Completion Date :

Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 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: PRFs PRFs will be completed by the physicians for seven of their consulting pSS subjects.
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 All subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation.

Arm

Intervention/Treatment

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

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: PRFs

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

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

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

Outcome Measures

Primary Outcome Measures

Physician reported categorization of pSS subjects [Baseline]
The most common categorization of pSS subjects by rheumatologists will be described, alongside differences in humanistic and clinical burden of these categories.
Statistically derived clusters of pSS subjects [Baseline]
Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.

Secondary Outcome Measures

Description of subject's journey [As reported]
Summary of subject's journeys from diagnosis to current management and treatment, including an overview of HCRU.
Drivers of physician and subject reported satisfaction [Baseline]
Data for drivers of physician and subjects reported satisfaction with disease activity control and symptomatic relief will be derived.
Level of concordance/discordance between physician and patient reported satisfaction [Baseline]
Data for discordance/concordance between physicians and subjects across key measures will be derived.
Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective [As reported / Baseline]
Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective will be described.
Physician experience of biologic therapy [Baseline]
Physicians' experience of biologic therapy, and attitudes towards biologic therapy for subjects with pSS will be described.
Physician perception of treatment targets [Baseline]
Physicians' perceptions of treatment targets in pSS will be described.
subjects attitude towards route of administration [Baseline]
Proportion of subjects willing to take medication by type of administration route (oral/tablet, subcutaneous injection, intravenously) will be described.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Adelphi Real World Investigational Site	Cheshire		United Kingdom	SK10 5JB

Sponsors and Collaborators

GlaxoSmithKline
Adelphi Real World

Investigators

Study Director: 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)