- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501420
Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP)
January 21, 2019 updated by: GlaxoSmithKline
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2223
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cheshire, United Kingdom, SK10 5JB
- Adelphi Real World Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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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
PRFs will be completed by the physicians for seven of their consulting pSS subjects.
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Subjects with pSS
Subjects with a confirmed diagnosis of pSS under consultation of the rheumatologists enrolled in the study will be included.
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All subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician reported categorization of pSS subjects
Time Frame: Baseline
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The most common categorization of pSS subjects by rheumatologists will be described, alongside differences in humanistic and clinical burden of these categories.
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Baseline
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Statistically derived clusters of pSS subjects
Time Frame: Baseline
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Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Description of subject's journey
Time Frame: As reported
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Summary of subject's journeys from diagnosis to current management and treatment, including an overview of HCRU.
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As reported
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Drivers of physician and subject reported satisfaction
Time Frame: Baseline
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Data for drivers of physician and subjects reported satisfaction with disease activity control and symptomatic relief will be derived.
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Baseline
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Level of concordance/discordance between physician and patient reported satisfaction
Time Frame: Baseline
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Data for discordance/concordance between physicians and subjects across key measures will be derived.
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Baseline
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Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective
Time Frame: As reported / Baseline
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Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective will be described.
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As reported / Baseline
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Physician experience of biologic therapy
Time Frame: Baseline
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Physicians' experience of biologic therapy, and attitudes towards biologic therapy for subjects with pSS will be described.
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Baseline
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Physician perception of treatment targets
Time Frame: Baseline
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Physicians' perceptions of treatment targets in pSS will be described.
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Baseline
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subjects attitude towards route of administration
Time Frame: Baseline
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Proportion of subjects willing to take medication by type of administration route (oral/tablet, subcutaneous injection, intravenously) will be described.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2018
Primary Completion (Actual)
October 30, 2018
Study Completion (Actual)
October 30, 2018
Study Registration Dates
First Submitted
April 10, 2018
First Submitted That Met QC Criteria
April 10, 2018
First Posted (Actual)
April 18, 2018
Study Record Updates
Last Update Posted (Actual)
January 23, 2019
Last Update Submitted That Met QC Criteria
January 21, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Lacrimal Apparatus Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Dry Eye Syndromes
- Syndrome
- Sjogren's Syndrome
Other Study ID Numbers
- 207382
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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