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

NCT03509064 | Recruiting

• 2 other identifiers: NI17025J2017-A02858-45
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Primary sjogren syndrome; Small fiber neuropathy; Quality of life; Medico-economic impact

Outcome Measures

Primary Outcomes (1)

• Measure of quality of life impairment by SF 36 scale

  For each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning). It easy to set up a computerised database (e.g., in MS Excel or similar) to calculate the percentages and averages

  Month 3

Secondary Outcomes (8)

• Hospitalization costs'

  during a period of 6 months

• Drug costs'

  during a period of 6 months

• City care costs'

  during a period of 6 months

• Distribution of cost items

  during a period of 6 months

• Part of costs attributable to primary Sjögren syndrome-associated small fiber neuropathy.

  during a period of 6 months

Study Arms (2)

1: Patients with small fiber neuropathy

patients with Sjogren syndrome have a definite small fiber neuropathy

Other: Collection sheet

2: Patients without peripheral neuropathy

patients with Sjogren syndrome without signs of peripheral neuropathy (small or large fiber)

Interventions

Collection sheet OTHER

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

1: Patients with small fiber neuropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All included patients fulfilled 2002-criteria of primary Sjogren syndrome.

You may qualify if:

• 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®)
• (iii) abnormal intraepidermal nerve fiber density (skin biopsy)
• Arm2 (control group): patients without signs of peripheral neuropathy (small or large fiber)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• LFB BIOMEDICAMENTS: collaborator

Study Sites (1)

Département de Médecine Interne - Hôpital Lariboisière

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Damien SÈNE

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien SÈNE, MD, PhD

CONTACT

+33149956380; damien.sene@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: April 26, 2018
• Study Start: January 14, 2019
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): January 14, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

FR (1)