Actively Recruiting

Age: 18Years +
All Genders
NCT03509064

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-05

100

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

L

LFB BIOMEDICAMENTS

Collaborating Sponsor

AI-Summary

What this Trial Is About

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: * The impact of SFN on the quality of life of patients with Sjögren's syndrome. * The medico-economic impact of the SFN taking into account the repercussions on the quality of life, including professional life, usual care cost (analgesics, medical and paramedical consultations, hospitalizations or emergency). EXPECTED RESULTS * Confirmation of the major impairment in the quality of life of patients with Sjogren-associated SFN * Analysis of correlations to highlight or not clinical or biological factors associated with quality of life impairment. * Evaluation of the cost attributed to the presence of an SFN in patients with Sjögren's syndrome and the pharmaco-economic interest of conventional therapeutic management (analgesic treatment, consultation pain) compared to the cost of more aggressive immunomodulatory treatments.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Definite primary Sj�gren syndrome diagnosis
  • Age over 18 years
  • No biologic or immunoglobulin therapy in the 6 months before study start
  • For Arm 1: clinical signs of small fiber neuropathy plus one paraclinical abnormality such as neurophysiological test or skin biopsy
  • For Arm 2 (control): no signs of peripheral neuropathy (small or large fiber)
Not Eligible

You will not qualify if you...

  • Presence of other causes of peripheral neuropathy including diabetes, AL amyloidosis, alcoholism, celiac disease, toxic drugs, HIV, sarcoidosis, systemic vasculitis, Guillain-Barr� syndrome
  • Hereditary neuropathies such as transthyretin hereditary amyloidosis, hereditary sensory and autonomic neuropathy, Fabry's disease
  • Patients with neuropathic symptoms but normal neurophysiological tests and skin biopsy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Département de Médecine Interne - Hôpital Lariboisière

Paris, France, 75010

Actively Recruiting

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Research Team

D

Damien SÈNE, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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