Sjogren's SyndromeNCT03501420
Adelphi Primary Sjogren's Syndrome (pSS) Disease Specific Programme (DSP)
An observational study of Sjogren's Syndrome, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Interview, PSC questionnaire and PRFs
- How many people
- 2,223 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jun 2018to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 10Show fewer
- 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)
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Adelphi Real World Investigational Site
Cheshire, SK10 5JB
About this study
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)
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.
- Conditions
- Sjogren's Syndrome
- Being tested
- Interview, PSC questionnaire, PRFs
- Keywords
- Belimumab, Disease Specific Programme, rheumatologist, Benlysta, Primary Sjögren's Syndrome, Adelphi pSS DSP
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
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 questionnaireOther
All subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation.
PRFsOther
PRFs will be completed by the physicians for seven of their consulting pSS subjects.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview; Other: PRFs | |
| Subjects with pSS | Subjects with a confirmed diagnosis of pSS under consultation of the rheumatologists enrolled in the study will be included. Receives: Other: PSC questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician reported categorization of pSS subjects
The most common categorization of pSS subjects by rheumatologists will be described, alongside differences in humanistic and clinical burden of these categories.
Measured: Baseline
Statistically derived clusters of pSS subjects
Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.
Measured: Baseline
Secondary outcomes (7)
Description of subject's journey
Summary of subject's journeys from diagnosis to current management and treatment, including an overview of HCRU.
Measured: As reported
Drivers of physician and subject reported satisfaction
Data for drivers of physician and subjects reported satisfaction with disease activity control and symptomatic relief will be derived.
Measured: Baseline
Level of concordance/discordance between physician and patient reported satisfaction
Data for discordance/concordance between physicians and subjects across key measures will be derived.
Measured: Baseline
Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective
Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective will be described.
Measured: As reported / Baseline
Physician experience of biologic therapy
Physicians' experience of biologic therapy, and attitudes towards biologic therapy for subjects with pSS will be described.
Measured: Baseline
Physician perception of treatment targets
Physicians' perceptions of treatment targets in pSS will be described.
Measured: Baseline
subjects attitude towards route of administration
Proportion of subjects willing to take medication by type of administration route (oral/tablet, subcutaneous injection, intravenously) will be described.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start13 Jun 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,223 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adelphi Real World
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501420
- Sponsor's protocol ID
- 207382
- Status last verified
- Jan 2019
- First submitted
- 10 Apr 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03501420
- Acronym / sponsor ID
- 207382
- Conditions
- Sjogren's Syndrome
- Keywords
- Belimumab, Disease Specific Programme, rheumatologist, Benlysta, Primary Sjögren's Syndrome, Adelphi pSS DSP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,223 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Adelphi Real World
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: Interview, Other: PRFsA 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. |
| Subjects with pSS | – | Other: PSC questionnaireSubjects with a confirmed diagnosis of pSS under consultation of the rheumatologists enrolled in the study will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
- 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)
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewA 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 | Physicians |
| PSC questionnaireAll subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation. | Other | Subjects with pSS |
| PRFsPRFs will be completed by the physicians for seven of their consulting pSS subjects. | Other | Physicians |
Primary outcome
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.
Statistically derived clusters of pSS subjects
Time frame: Baseline
Subject clusters will be statistically derived from demographic, clinical and humanistic characteristics.
7 secondary outcomes
Description of subject's journey
Time frame: As reported
Drivers of physician and subject reported satisfaction
Time frame: Baseline
Level of concordance/discordance between physician and patient reported satisfaction
Time frame: Baseline
Differences in subjects journey, physician and subjects reported satisfaction amongst the clusters identified in the primary objective
Time frame: As reported / Baseline
Physician experience of biologic therapy
Time frame: Baseline
Physician perception of treatment targets
Time frame: Baseline
subjects attitude towards route of administration
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician reported categorization of pSS subjects (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.