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

The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)

This study is trying to see how small fiber neuropathy affects the quality of life and costs for people with Sjögren's syndrome.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT03509064 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of primary Sjögren syndrome, particularly those experiencing small fiber neuropathy.

Not a fit: Patients with other causes of peripheral neuropathy or those currently receiving biologics or immunoglobulin therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the management and support of patients with Sjögren's syndrome and SFN, potentially improving their quality of life.

How similar studies have performed: While there is ongoing research into Sjögren's syndrome and neuropathy, this specific focus on the economic and quality of life impacts is relatively novel.

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.

Where this trial is running

Paris

• 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

Conditions Primary Sjögren Syndrome; Small Fiber Neuropathy; Quality of Life; Medico-economic Impact; Primary sjogren syndrome; Small fiber neuropathy; Quality of life; Medico-economic impact