Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 25, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the impact of small fiber neuropathy (SFN) on the quality of life and healthcare costs for patients with Sjögren's syndrome. Sjögren's syndrome is an autoimmune disease that mostly affects women between the ages of 40 and 60, leading to symptoms like dry eyes, dry mouth, and joint pain. In some patients, it can also cause painful nerve issues known as small fiber neuropathy, which can result in sensations like burning, numbness, and tingling. The trial aims to find out how much SFN affects daily life for these patients and what the related healthcare costs are.

To participate in the study, individuals must be at least 18 years old and have a confirmed diagnosis of primary Sjögren's syndrome. They should either have symptoms of small fiber neuropathy or be part of a control group with no neuropathy symptoms. Participants can expect to undergo various tests to assess their nerve function and quality of life. The findings from this study will help improve understanding of the burdens faced by patients with Sjögren's syndrome and may influence future treatment options and healthcare planning.

Gender

ALL

Eligibility criteria

• 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.