Primary Sjögren Syndrome

NCT01989819 | Completed

• 1 other identifier: I10 023
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 7

Brief Summary

Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often involving the central and peripheral nervous systems. Fifteen to twenty percent of patients with the primary Sjögren's syndrome have neurological complications involving the peripheral nervous system. Although some patients have large fiber neuropathy, around forty percent of patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms, some have been shown to have small fiber neuropathy (SFN). A recent study proved that more than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}. The aim of this study will be to investigate the occurrence of small fiber neuropathy in patients with pSS and neuropathic pain with normal electromyographic studies and to determine the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or auto-antibody response. Quantification of epidermal nerve fiber density after skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been widely validated. A skin biopsy will be performed in patients and control and will allow quantification of small fiber density in skin sample along with measurement of sweat gland innervation. Moreover, pathophysiological studies will be carried on in order to evaluate the causal relationship between cellular and humoral inflammation and small fiberneuropathy. Recent studies have pointed out the inconstant efficacy of both corticosteroid and immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small fiber neuropathy in these patients may help designing new therapeutic strategies.

Conditions

Primary Sjögren's Syndrome

Outcome Measures

Primary Outcomes (1)

• To evaluate the cutaneous lymphocytic infiltration

  1 year

Secondary Outcomes (1)

• Cutaneous infiltration T, B and Th17

  1 year

Study Arms (3)

patients with Sjögren's syndrome

A skin biopsy will be performed in patients

Other: skin biopsy

control group

A skin biopsy will be performed in control group

Other: skin biopsy

non auto-immune small fiber neuropathies

Interventions

skin biopsy OTHER

control group; patients with Sjögren's syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sjögren's syndrome

You may qualify if:

• Patients with pSS according to revised European criteria and exhibiting neuropathic pain without any electromyographic abnormality will be included (Group I).
• Age of entry into the study ≥ 18 yrs (both groups).
• Affiliated or profit patient of a social security system (both groups).
• Informed consent signed up (both groups).

You may not qualify if:

• Chronic alcoholism
• Type I or type II diabetes
• Peripheral neuropathy unrelated to pSS complications
• Coagulation disease
• Previous allergy to xylocaine, lidocaine, prilocaine or ricin oil
• Porphyria, methemoglobinemia
• Patients under measure of maintenance of justice.
• Patients unable to understand or to participate to the study.
• Child and major patients making the object of a measure of lawful protection.
• Patients deprived of freedom.
• Pregnant, nursing women.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (7)

CH d'Albi

Albi, 81000, France

Location

CHU Bordeaux

Bordeaux, 33000, France

Location

CH de Brive

Brive-la-Gaillarde, 19312, France

Location

CHU de Lille

Lille, 59037, France

Location

University Hospital, Limoges

Limoges, 87 042, France

Location

CH de Rodez

Rodez, 12000, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Study Officials

• Anne-Laure FAUCHAIS, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 21, 2013
• Study Start: September 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2017
• Last Updated: January 11, 2019

Record last verified: 2016-06

Locations

FR (7)