Health TrialsbyHealthPanel

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

ConditionsPrimary Sjögren SyndromeSmall Fiber NeuropathyQuality of LifeMedico-economic Impact
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Definite primary Sjögren syndrome

Age over 18 years

No biologics nor immunoglobulin therapy during the 6 months before study onset

(i) Clinical signs of small fibers involvement: thermo-algic sensory deficit or autonomic dysfunction or neuropathic pain with DN4 ≥4;

Disqualifiers

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 population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Collection sheet

    Other intervention

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 1: Patients with small fiber neuropathy1 intervention
Group B: 2: Patients without peripheral neuropathy0 interventions

Trial outcomes

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

Time frame
Month 3

Secondary outcomes

1

Hospitalization costs'

using a collection sheet

Time frame
during a period of 6 months
2

Drug costs'

using a collection sheet

Time frame
during a period of 6 months
3

City care costs'

using a collection sheet

Time frame
during a period of 6 months
4

Distribution of cost items

using a collection sheet

Time frame
during a period of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

LFB BIOMEDICAMENTS

Collaborator

Source ClinicalTrials.gov
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