Primary Sjögren Syndrome (NeuroSenSS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2011 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01989819
First received: November 6, 2013
Last updated: December 2, 2013
Last verified: October 2011
  Purpose

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.


Condition Intervention
Primary Sjögren's Syndrome
Other: skin biopsy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • To evaluate the cutaneous lymphocytic infiltration [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cutaneous infiltration T, B and Th17 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Sjögren's syndrome

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Participation in biomedical research within one month prior to inclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989819

Contacts
Contact: Anne-Laure FAUCHAIS, MD (+33) 5 55 05 65 03 anne-laure.fauchais@chu-limoges.fr

Locations
France
CH d'Albi Recruiting
Albi, France, 81000
Contact: Serge Madaule, MD    (+33) 5 63 47 42 86    serge.madaule@ch-albi.rss.fr   
Principal Investigator: Serge Madaule, MD         
CHU Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Patrick Mercié    (+33) 5 56 79 57 28    patrick.mercie@chu-bordeaux.fr   
Principal Investigator: Patrick Mercié, MD         
CH de Brive Recruiting
Brive la Gaillarde, France, 19312
Contact: Bruno Abraham, MD    (+33) 5 55 92 60 40    BRUNO.ABRAHAM@ch-brive.fr   
Principal Investigator: Bruno ABRAHAM, MD         
CHU de Lille Recruiting
Lille, France, 59037
Contact: Pierre-Yves Hatron    (+33) 3 20 44 42 95    pyhatron@chru-lille.fr   
Principal Investigator: Pierre-Yves Hatron, MD         
University Hospital, Limoges Recruiting
Limoges, France, 87 042
Contact: Anne-Laure FAUCHAIS, MD    (+33) 5 55 05 86 21    anne-laure.fauchais@chu-limoges.fr   
Principal Investigator: Anne-Laure FAUCHAIS, MD         
CH de Rodez Recruiting
Rodez, France, 12000
Contact: Françoise Brevet, MD    (+33) 5 65 55 22 80    f.brevet@ch-rodez.fr   
Principal Investigator: Françoise BREVET, MD         
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Philippe ARLET, MD    (+33) 5 61 77 95 50    arlet.p@chu-toulouse.fr   
Principal Investigator: Philippe ARLET, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Anne-Laure FAUCHAIS, MD University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01989819     History of Changes
Other Study ID Numbers: I10 023
Study First Received: November 6, 2013
Last Updated: December 2, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Salivary Gland Diseases
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014