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

NCT03509064 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-02-05

No results posted yet for this study

Summary

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

  • Primary Sjögren Syndrome
  • Small Fiber Neuropathy
  • Quality of Life
  • Medico-economic Impact

Interventions

OTHER

Collection sheet

Using EQ5D questionnaire and a collection of care resources consumed by the patients during a period of 6 months associated by using validated scales (SF36, DN4, PROFAD SSI, ESPRI) : collection sheet

Sponsors & Collaborators

  • LFB BIOMEDICAMENTS

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Damien SÈNE · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2027-01-14
Completion
2027-01-14

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03509064 on ClinicalTrials.gov