Stratified medicine in primary Sjogren’s syndrome

Stratified medicine in primary Sjogren’s syndrome: a mixed methods quantitative/qualitative study to develop a patient-reported questionnaire looking at disease burden within the Primary Sjogren's Syndrome subtypes

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16054712

Enrollment

600

Registered

2023-08-08

Start date

2021-03-01

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogren's Syndrome Musculoskeletal Diseases

Interventions

The aim of the study is to collect information on the disease impact and burden of PSS on patients. This information will be collected using questionnaires due to the large cohort (600 participants) a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. Confirmed diagnosis of primary Sjögren’s syndrome 3. Willing and able to provide informed written consent 4. Registered within a PSS registry

Exclusion criteria

Exclusion criteria: 1. Unable to provide written consent

Design outcomes

Primary

Measure	Time frame
The following data is collected through a one off questionnaire by post. 1. Quality of life measured using EQ5D 2. Wellbeing measured using ICECAPA 3. Anxiety and depression measured using HADs 4. Sjogren's symptoms measured using ESSPRI 5. Fatigue is measured using PROFAD 6. Patient developed measure to include to include; Clinical Health Services (primary and secondary), extra services not covered by the health service – such as cost of prescriptions, dental, opticians, and alternative therapies, employment, family life and activities – such as holidays.	—

Measure

Time frame

The following data is collected through a one off questionnaire by post. 1. Quality of life measured using EQ5D 2. Wellbeing measured using ICECAPA 3. Anxiety and depression measured using HADs 4. Sjogren's symptoms measured using ESSPRI 5. Fatigue is measured using PROFAD 6. Patient developed measure to include to include; Clinical Health Services (primary and secondary), extra services not covered by the health service – such as cost of prescriptions, dental, opticians, and alternative therapies, employment, family life and activities – such as holidays.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, France, Norway, Sweden, United Kingdom

Contacts

Public ContactVictoria Macrae

victoria.macrae@newcastle.ac.uk+44 (0)191 2137341

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026