Actively Recruiting
The Medico-economic Impact and Quality of Life of Small Fiber Neuropathy in Primary Sj f6gren Syndrome Using Validated Scales
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-05
100
Participants Needed
1
Research Sites
N/A
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
Researchers are investigating the impact of small fiber neuropathy (SFN) on quality of life and economic costs in patients with primary Sj f6gren syndrome, an autoimmune disease mainly affecting women aged 40 to 60. This study aims to confirm the extent of quality of life impairment caused by SFN, analyze clinical or biological factors linked to this impairment, and evaluate the costs related to SFN management compared to conventional therapies. The study includes two groups: patients with primary Sj f6gren syndrome who have definite SFN and those without any signs of peripheral neuropathy. Participants will complete validated questionnaires such as SF-36 for quality of life, DN4 for neuropathic pain, EQ5D, ESSPRI, and PROFAD-SSI to assess symptoms and effects. Economic evaluation will consider hospital, drug, and city-care costs over a six-month period. Participants will undergo an inclusion visit during which these questionnaires and data on care resources used over six months will be collected. The primary outcome is the measure of quality of life impairment at three months using the SF-36 scale. Secondary outcomes include various cost assessments and correlations between quality of life and costs. The study is conducted at a single center and aims to provide a comprehensive understanding of SFN's impact on patients with Sj f6gren syndrome.
CONDITIONS
Brief Title
Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Definite primary Sj�f6gren syndrome
- Age over 18 years
- No biologic or immunoglobulin therapy during the 6 months before study start
- For Arm 1: presence of clinical signs of small fiber involvement AND at least one neurophysiological or biopsy abnormality
- For Arm 2 (control): absence of clinical and paraclinical signs of peripheral neuropathy
You will not qualify if you...
- Presence of other causes of peripheral neuropathy such as diabetes, AL amyloidosis, alcoholism, celiac disease, drug toxicity, HIV, sarcoidosis, systemic vasculitis, Guillain-Barr�e9 syndrome
- Hereditary neuropathies including transthyretin hereditary amyloidosis, hereditary sensory and autonomic neuropathy, Fabry's disease
- Patients with neuropathic symptoms and DN4 64 but normal neurophysiological tests and skin biopsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants complete validated questionnaires and their medical resource use is tracked to assess quality of life and economic impact over a 6-month period.
1 baseline visit and periodic questionnaire completion
Trial Site Locations
Total: 1 location
1
Département de Médecine Interne - Hôpital Lariboisière
Paris, France, 75010
Actively Recruiting
Research Team
D
Damien SÈNE, MD, PhD
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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