What role do immune cells have in the development and persistence of Sjögren's syndrome?

What role do immune cells have in the development and persistence of Sjögren's syndrome? - Role of immune cells in Sjögren's Syndrome.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33948

Enrollment

400

Registered

2009-07-07

Start date

2010-05-06

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

(primary) Sjögren's syndrome sicca syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1: Patients (>= 18 yr) with sicca complaints, with a suspicion of Sjögren's syndrome, and that will undergo lipbiopsy as a diagnostic tool Group 2: Patients (>= 18 yr), who are diagnosed with Sjögren's syndrome, according to the revised American-European consensus group (Vitali, Bombardieri et al. 2002), with a lymphocytic focus score >=1 on minor salivary gland biopsy. Patients (>= 18 yr), who are diagnosed with non-Sjögren's sicca syndrome, with a lymphocytic focus score of 0 on minor salivary gland biopsy. Healthy controls (>= 18 yr), recruited from the Minidonordienst (inhouse blood donating service) of the UMC Utrecht, who are free of the use of immunosuppressive drugs.

Exclusion criteria

Exclusion criteria: Patients with any other causes of dryness will not be included in this study. Individuals that are not free of the use of immunosuppressive drugs at least 3 months prior to this study.

Design outcomes

Primary

Measure	Time frame
Primary immunological parameters: 1. activation of several types of immune cells before and after stimulation with and without blockade of this stimulation (read-out measurements: proliferation, activation markers, cytokine production and other inflammatory mediators) 2. cytokine en biomarker profiles in serum and saliva. These parameters will be compared between Sjögren patiënts, non-Sjögren sicca patients, and healthy controls as outcome measurements.	—

Measure

Time frame

Primary immunological parameters: 1. activation of several types of immune cells before and after stimulation with and without blockade of this stimulation (read-out measurements: proliferation, activation markers, cytokine production and other inflammatory mediators) 2. cytokine en biomarker profiles in serum and saliva. These parameters will be compared between Sjögren patiënts, non-Sjögren sicca patients, and healthy controls as outcome measurements.

—

Secondary

Measure	Time frame
These parameters will be compared between Sjögren patiënts and non-Sjögren sicca patients as outcome measurements. 3. General disease parameters, which will be measured during their annual visit to the outpatient clinic of the UMC Utrecht. (e.g. immunoglobulines, ESR, leukocyte count). 4. unstimulated and stimulated salivary flow 5. unstimulated tear production 6. brief impression of general fatigue symptoms, and subjective dryness of mouth and eyes with the use of questionnaires	—

Measure

Time frame

These parameters will be compared between Sjögren patiënts and non-Sjögren sicca patients as outcome measurements. 3. General disease parameters, which will be measured during their annual visit to the outpatient clinic of the UMC Utrecht. (e.g. immunoglobulines, ESR, leukocyte count). 4. unstimulated and stimulated salivary flow 5. unstimulated tear production 6. brief impression of general fatigue symptoms, and subjective dryness of mouth and eyes with the use of questionnaires

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Countries

Netherlands

Outcome results