An observational study in Primary Sjögren Syndrome, Small Fiber Neuropathy and Quality of Life, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
BACKGROUND Sjögren's syndrome is an autoimmune disease whose prevalence is estimated between 200 and 500 patients per 100,000 persons in France (120 to 500,000 patients). It affects women (90%) between 40 and 60 years of age and main manifestations are generalized sicca syndrome (ocular, oral, cutaneous) and arthralgia. In 20% of cases, Sjögren's syndrome is associated with peripheral neuropathies, and the most common form is painful small fiber neuropathy (SFN). SFNs are mainly featured by neuropathic pain including burns (90%), numbness (87.5%), tingling (72.5%), electric shocks (70%) and tingling (82.5%) and also autonomic disorders (50 to 70%).
However, there are still important issues that deserve to be investigated by clinical and basic research. Among these issues, this study will focus on:
EXPECTED RESULTS
Primary objective: Identify the predictors of quality of life impairment and costs of management of patients with Sjögren's syndrome and small fiber neuropathy (SFN).
Secondary objectives :
PATIENTS AND METHODS / Study population
Monocentric study in the Department of Internal Medicine of Lariboisière Fernand Widal Hospital.
All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
Patients are classified into 2 arms:
Arm1: patients with Sjögren's syndrome and definite SFN
Arm2 ( Control Group) : patients with Sjögren's syndrome and WITHOUT clinical and paraclinical arguments for peripheral neuropathy
RESARCH PROCESS
This study will be based on the delivery and analysis of validated questionnaires (collection sheet) in chronic diseases, pains or Sjögren's syndrome:
50 studies on the registry are indexed under Small Fiber Neuropathy; 12 are open to participants now.
This study's planned enrollment of 100 is close to the median of 93 across 18 observational studies indexed under Small Fiber Neuropathy.
Browse Small Fiber Neuropathy studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Arm 1: patients with a small fiber neuropathy defined by the presence of a clinical AND one paraclinical abnormality
Arm2 (control group): patients without signs of peripheral neuropathy (small or large fiber)
Exclusion Criteria:
Presence of other causes of peripheral neuropathy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients with Sjogren syndrome have a definite small fiber neuropathy
Other: Collection sheet
patients with Sjogren syndrome without signs of peripheral neuropathy (small or large fiber)
Using EQ5D questionnaire and a collection of care resources consumed by the patients during a period of 6 months associated by using validated scales (SF36, DN4, PROFAD SSI, ESPRI) : collection sheet
Measure of quality of life impairment by SF 36 scale
For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning). It easy to set up a computerised database (e.g., in MS Excel or similar) to calculate the percentages and averages
Time frame: Month 3
Hospitalization costs'
using a collection sheet
Time frame: during a period of 6 months
Drug costs'
using a collection sheet
Time frame: during a period of 6 months
City care costs'
using a collection sheet
Time frame: during a period of 6 months
Distribution of cost items
using a collection sheet
Time frame: during a period of 6 months
Part of costs attributable to primary Sjögren syndrome-associated small fiber neuropathy.
using a collection sheet
Time frame: during a period of 6 months
Loss of quality of life attributable to primary Sjögren syndrome-associated small fiber neuropathy.
The loss of quality of life is appreciated by using a collection sheet (detailed in the research process)
Time frame: during a period of 6 months
Evaluation of the domains of the EQ 5D questionnaire
using a collection sheet
Time frame: during a period of 6 months
Evaluation of specific quality of life questionnaire
using a collection sheet
Time frame: during a period of 6 months
Plan to share: Undecided
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