NCT03509064 Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
| NCT ID | NCT03509064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Primary Sjögren Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2019-01-14 |
| Primary Completion | 2027-01-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2019-01-14 with a primary completion date of 2027-01-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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®) * OR * (iii) abnormal intraepidermal nerve fiber density (skin biopsy) Arm2 (control group): patients without signs of peripheral neuropathy (small or large fiber) Exclusion Criteria: * 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.
Contact & Investigator
Damien SÈNE
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT03509064 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Sjögren Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03509064 currently recruiting?
Yes, NCT03509064 is actively recruiting participants. Contact the research team at damien.sene@aphp.fr for enrollment information.
Where is the NCT03509064 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT03509064 clinical trial?
NCT03509064 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Damien SÈNE at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 100 participants.