Primary Sjögren's SyndromeNeuroSenSSNCT01989819
Primary Sjögren Syndrome
An observational study of Primary Sjögren's Syndrome, run by University Hospital, Limoges at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Sjögren's Syndrome
- What is being tested?
- skin biopsy
- How many people
- 44 participants
- Where
- 7 sitesFrance
- Study dates
- Sep 2012to Jun 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Sjögren's syndrome
Who may be able to join
- 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).
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CH d'Albi
Albi, 81000
CHU Bordeaux
Bordeaux, 33000
CH de Brive
Brive-la-Gaillarde, 19312
CHU de Lille
Lille, 59037
University Hospital, Limoges
Limoges, 87 042
CH de Rodez
Rodez, 12000
CHU Toulouse
Toulouse, 31059
About this study
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
- Being tested
- skin biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| patients with Sjögren's syndrome | A skin biopsy will be performed in patients Receives: Other: skin biopsy | |
| control group | A skin biopsy will be performed in control group Receives: Other: skin biopsy | |
| non auto-immune small fiber neuropathies | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the cutaneous lymphocytic infiltration
Measured: 1 year
Secondary outcomes (1)
Cutaneous infiltration T, B and Th17
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Laure FAUCHAIS, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989819
- Sponsor's protocol ID
- I10 023
- Acronym
- NeuroSenSS
- Status last verified
- Jun 2016
- First submitted
- 6 Nov 2013
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Sjögren Syndrome
- ClinicalTrials.gov ID
- NCT01989819
- Acronym / sponsor ID
- NeuroSenSS / I10 023
- Conditions
- Primary Sjögren's Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 Nov 2013 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with Sjögren's syndrome | – | Other: skin biopsyA skin biopsy will be performed in patients |
| control group | – | Other: skin biopsyA skin biopsy will be performed in control group |
| non auto-immune small fiber neuropathies | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Sjögren's syndrome
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| skin biopsy | Other | control group, patients with Sjögren's syndrome |
Primary outcome
To evaluate the cutaneous lymphocytic infiltration
Time frame: 1 year
1 secondary outcome
Cutaneous infiltration T, B and Th17
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
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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. This study is not recruiting at the moment.
Anne-Laure FAUCHAIS, MD principal investigator
University Hospital, Limoges
7 sites 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's Syndrome, run by University Hospital, Limoges at 7 sites 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the cutaneous lymphocytic infiltration (time frame: 1 year). 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 11 Jan 2019.