Primary Sjögren SyndromeSFINESS-QoLEcoNCT03509064
Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
An observational study of Primary Sjögren Syndrome and Small Fiber Neuropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren Syndrome, Small Fiber Neuropathy, Quality of Life
- What is being tested?
- Collection sheet
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2019to 14 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
Who may be able to join
- 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
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- (ii) Small fibers neurophysiological abnormalities (QST, laser evoked potentials, autonomic nervous system tests (sympathetic skin response test or Sudoscan®)
- OR
- (iii) abnormal intraepidermal nerve fiber density (skin biopsy)
- Arm2 (control group): patients without signs of peripheral neuropathy (small or large fiber)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Département de Médecine Interne - Hôpital Lariboisière
Paris, 75010
Damien SÈNE, MD, PhD, +33149956380, damien.sene@aphp.fr
About this study
Official title: The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)
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:
Read more
- 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.
Read the detailed description
Primary objective: Identify the predictors of quality of life impairment and costs of management of patients with Sjögren's syndrome and small fiber neuropathy (SFN).
Secondary objectives :
- Hospital, drug and city-care costs
- Distribution of cost items
- Part of costs attributable to pSS-associated SFN
- Loss of quality of life attributable to pSS-associated SFN
- Relationship between the domains of the EQ 5D questionnaire and the other specific quality of life questionnaires
- Association of the EQ 5D and other questionnaires with the costs (part of the costs variance that might be explained by the quality of life).
PATIENTS AND METHODS / Study population
Monocentric study in the Department of Internal Medicine of Lariboisière Fernand Widal Hospital.
All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
Patients are classified into 2 arms:
Arm1: patients with Sjögren's syndrome and definite SFN
Arm2 ( Control Group) : patients with Sjögren's syndrome and WITHOUT clinical and paraclinical arguments for peripheral neuropathy
RESARCH PROCESS
This study will be based on the delivery and analysis of validated questionnaires (collection sheet) in chronic diseases, pains or Sjögren's syndrome:
- SF-36 for quality of life,
- DN4 questionnaire to estimate the probability of neuropathic pain
- EQ5D Health questionnaire
- ESSPRI (4 questions): Sjogren-patient questionnaire
- PROFAD-SSI (19 questions), to assess tiredness, discomfort, pain and dryness symptoms associated with Sjögren's syndrome.
- The economic evaluation will be done after the inclusion visit and will be based on the collection of care resources consumed by the patients during a period of 6 months
- Being tested
- Collection sheet
- Keywords
- Primary sjogren syndrome, Small fiber neuropathy, Quality of life, Medico-economic impact
- Medical subject headings
- Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection sheetOther
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
| Study group | Role | What they receive |
|---|---|---|
| 1: Patients with small fiber neuropathy | patients with Sjogren syndrome have a definite small fiber neuropathy Receives: Other: Collection sheet | |
| 2: Patients without peripheral neuropathy | patients with Sjogren syndrome without signs of peripheral neuropathy (small or large fiber) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 3
Secondary outcomes (8)
Hospitalization costs'
using a collection sheet
Measured: during a period of 6 months
Drug costs'
using a collection sheet
Measured: during a period of 6 months
City care costs'
using a collection sheet
Measured: during a period of 6 months
Distribution of cost items
using a collection sheet
Measured: during a period of 6 months
Part of costs attributable to primary Sjögren syndrome-associated small fiber neuropathy.
using a collection sheet
Measured: during a period of 6 months
Loss of quality of life attributable to primary Sjögren syndrome-associated small fiber neuropathy.
The loss of quality of life is appreciated by using a collection sheet (detailed in the research process)
Measured: during a period of 6 months
Evaluation of the domains of the EQ 5D questionnaire
using a collection sheet
Measured: during a period of 6 months
Evaluation of specific quality of life questionnaire
using a collection sheet
Measured: during a period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start14 Jan 2019
- Primary completion14 Jan 2027 (estimated)
- Study completion14 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- LFB BIOMEDICAMENTS
- Responsible party
- Sponsor
- Investigators
- Damien SÈNE, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509064
- Sponsor's protocol ID
- NI17025J
- Other IDs
- 2017-A02858-45
- Acronym
- SFINESS-QoLEco
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2018
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)
- ClinicalTrials.gov ID
- NCT03509064
- Acronym / sponsor ID
- SFINESS-QoLEco / NI17025J
- Keywords
- Primary sjogren syndrome, Small fiber neuropathy, Quality of life, Medico-economic impact
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- LFB BIOMEDICAMENTS
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 14 Jan 2027 (estimated)
- Study completion
- 14 Jan 2027 (estimated)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary objective: Identify the predictors of quality of life impairment and costs of management of patients with Sjögren's syndrome and small fiber neuropathy (SFN).
Secondary objectives :
- Hospital, drug and city-care costs
- Distribution of cost items
- Part of costs attributable to pSS-associated SFN
- Loss of quality of life attributable to pSS-associated SFN
- Relationship between the domains of the EQ 5D questionnaire and the other specific quality of life questionnaires
- Association of the EQ 5D and other questionnaires with the costs (part of the costs variance that might be explained by the quality of life).
PATIENTS AND METHODS / Study population
Monocentric study in the Department of Internal Medicine of Lariboisière Fernand Widal Hospital.
All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
Patients are classified into 2 arms:
Arm1: patients with Sjögren's syndrome and definite SFN
Arm2 ( Control Group) : patients with Sjögren's syndrome and WITHOUT clinical and paraclinical arguments for peripheral neuropathy
RESARCH PROCESS
This study will be based on the delivery and analysis of validated questionnaires (collection sheet) in chronic diseases, pains or Sjögren's syndrome:
- SF-36 for quality of life,
- DN4 questionnaire to estimate the probability of neuropathic pain
- EQ5D Health questionnaire
- ESSPRI (4 questions): Sjogren-patient questionnaire
- PROFAD-SSI (19 questions), to assess tiredness, discomfort, pain and dryness symptoms associated with Sjögren's syndrome.
- The economic evaluation will be done after the inclusion visit and will be based on the collection of care resources consumed by the patients during a period of 6 months
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Patients with small fiber neuropathy | – | Other: Collection sheetpatients with Sjogren syndrome have a definite small fiber neuropathy |
| 2: Patients without peripheral neuropathy | – | –patients with Sjogren syndrome without signs of peripheral neuropathy (small or large fiber) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (4 listed)
- Presence of other causes of peripheral neuropathy
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection sheetUsing 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 | Other | 1: Patients with small fiber neuropathy |
Primary outcome
Measure of quality of life impairment by SF 36 scale
Time frame: Month 3
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
8 secondary outcomes
Hospitalization costs'
Time frame: during a period of 6 months
Drug costs'
Time frame: during a period of 6 months
City care costs'
Time frame: during a period of 6 months
Distribution of cost items
Time frame: during a period of 6 months
Part of costs attributable to primary Sjögren syndrome-associated small fiber neuropathy.
Time frame: during a period of 6 months
Loss of quality of life attributable to primary Sjögren syndrome-associated small fiber neuropathy.
Time frame: during a period of 6 months
Evaluation of the domains of the EQ 5D questionnaire
Time frame: during a period of 6 months
Evaluation of specific quality of life questionnaire
Time frame: during a period of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damien SÈNE principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sjögren Syndrome and Small Fiber Neuropathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien SÈNE, MD, PhD (+33149956380, damien.sene@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of quality of life impairment by SF 36 scale (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.