SFINESS-QoLEco
The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)
Sponsor study identifier
Secondary identifiers
OTHER · IDRCB
observational
100
1 country
1
Study Start
January 14, 2019
Actual (reported)Primary Completion
January 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2018
Actual (reported)April 26, 2018
Actual (reported)January 14, 2019
Actual (reported)January 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Hospitalization costs'
during a period of 6 months
Drug costs'
during a period of 6 months
patients with Sjogren syndrome have a definite small fiber neuropathy
patients with Sjogren syndrome without signs of peripheral neuropathy (small or large fiber)
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
Département de Médecine Interne - Hôpital Lariboisière
Paris, 75010, France
Damien SÈNE
Assistance Publique - Hôpitaux de Paris
First Submitted
February 26, 2018
First Posted
April 26, 2018
Study Start
January 14, 2019
Actual (reported)Primary Completion
January 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Contact the study team to confirm eligibility.
Study Completion
January 14, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 5, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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