Impact of Sjögren's syndrome on quality of life and costs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the impact of small fiber neuropathy (SFN) on the quality of life and the economic burden for patients with primary Sjögren's syndrome. It will involve a monocentric approach at the Lariboisière Fernand Widal Hospital, where patients will be classified into two groups: those with Sjögren's syndrome and SFN, and those without neuropathy. The study will utilize validated questionnaires to gather data on quality of life, pain, and associated healthcare costs, focusing on identifying predictors of impairment and economic impact.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Definite primary Sjögren syndrome
* Age over 18 years
* No biologics nor immunoglobulin therapy during the 6 months before study onset

Arm 1: patients with a small fiber neuropathy defined by the presence of a clinical AND one paraclinical abnormality

* (i) Clinical signs of small fibers involvement: thermo-algic sensory deficit or autonomic dysfunction or neuropathic pain with DN4 ≥4;
* AND
* (ii) Small fibers neurophysiological abnormalities (QST, laser evoked potentials, autonomic nervous system tests (sympathetic skin response test or Sudoscan®)
* OR
* (iii) abnormal intraepidermal nerve fiber density (skin biopsy)

Arm2 (control group): patients without signs of peripheral neuropathy (small or large fiber)

Exclusion Criteria:

* Presence of other causes of peripheral neuropathy

  * Acquired: Diabetes, AL amyloidosis, Alcoholism, celiac disease, Drugs, toxic, HIV, Sarcoidosis, systemic vasculitis, Guillain-Barré syndrome.
  * Hereditary: Transthyretin hereditary amyloidosis (TTR), hereditary sensory and autonomic neuropathy (HSAN), Fabry's disease
* Patients with impaired thermo-algic sensitivity and / or dysautonomia and / or pain with DN4 ≥ 4 AND normal diagnostic tests (normal neurophysiological tests AND normal skin biopsy) are excluded.

Where it's running

• Département de Médecine Interne - Hôpital Lariboisière
  Paris, France Recruiting

Study contacts

• Principal investigator: Damien SÈNE — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Damien SÈNE, MD, PhD
• Email: damien.sene@aphp.fr
• Phone: +33149956380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.