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Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy (SFINESS-QoLEco)

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ClinicalTrials.gov Identifier: NCT03509064
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
LFB BIOMEDICAMENTS
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Primary Sjögren Syndrome Small Fiber Neuropathy Quality of Life Medico-economic Impact Other: Collection sheet

Detailed Description:

Primary objective: Identify the predictors of quality of life impairment and costs of management of patients with Sjögren's syndrome and small fiber neuropathy (SFN).

Secondary objectives :

  1. Hospital, drug and city-care costs
  2. Distribution of cost items
  3. Part of costs attributable to pSS-associated SFN
  4. Loss of quality of life attributable to pSS-associated SFN
  5. Relationship between the domains of the EQ 5D questionnaire and the other specific quality of life questionnaires
  6. Association of the EQ 5D and other questionnaires with the costs (part of the costs variance that might be explained by the quality of life).

PATIENTS AND METHODS / Study population

Monocentric study in the Department of Internal Medicine of Lariboisière Fernand Widal Hospital.

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

Patients are classified into 2 arms:

Arm1: patients with Sjögren's syndrome and definite SFN

Arm2 ( Control Group) : patients with Sjögren's syndrome and WITHOUT clinical and paraclinical arguments for peripheral neuropathy

RESARCH PROCESS

This study will be based on the delivery and analysis of validated questionnaires (collection sheet) in chronic diseases, pains or Sjögren's syndrome:

  • SF-36 for quality of life,
  • DN4 questionnaire to estimate the probability of neuropathic pain
  • EQ5D Health questionnaire
  • ESSPRI (4 questions): Sjogren-patient questionnaire
  • PROFAD-SSI (19 questions), to assess tiredness, discomfort, pain and dryness symptoms associated with Sjögren's syndrome.
  • The economic evaluation will be done after the inclusion visit and will be based on the collection of care resources consumed by the patients during a period of 6 months

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)
Actual Study Start Date : January 11, 2019
Estimated Primary Completion Date : January 11, 2021
Estimated Study Completion Date : January 11, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1: Patients with small fiber neuropathy
patients with Sjogren syndrome have a definite small fiber neuropathy
Other: Collection sheet
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

2: Patients without peripheral neuropathy
patients with Sjogren syndrome without signs of peripheral neuropathy (small or large fiber)
Other: Collection sheet
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




Primary Outcome Measures :
  1. Measure of quality of life impairment by SF 36 scale [ Time Frame: Month 3 ]

    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



Secondary Outcome Measures :
  1. Hospitalization costs' [ Time Frame: during a period of 6 months ]
    using a collection sheet

  2. Drug costs' [ Time Frame: during a period of 6 months ]
    using a collection sheet

  3. City care costs' [ Time Frame: during a period of 6 months ]
    using a collection sheet

  4. Distribution of cost items [ Time Frame: during a period of 6 months ]
    using a collection sheet

  5. Part of costs attributable to primary Sjögren syndrome-associated small fiber neuropathy. [ Time Frame: during a period of 6 months ]
    using a collection sheet

  6. Loss of quality of life attributable to primary Sjögren syndrome-associated small fiber neuropathy. [ Time Frame: during a period of 6 months ]
    The loss of quality of life is appreciated by using a collection sheet (detailed in the research process)

  7. Evaluation of the domains of the EQ 5D questionnaire [ Time Frame: during a period of 6 months ]
    using a collection sheet

  8. Evaluation of specific quality of life questionnaire [ Time Frame: during a period of 6 months ]
    using a collection sheet



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All included patients fulfilled 2002-criteria of primary Sjogren syndrome.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509064


Contacts
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Contact: Damien SÈNE, MD, PhD +33149956380 damien.sene@aphp.fr

Locations
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France
Département de Médecine Interne - Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Damien SÈNE, MD, PhD    +33149956380    damien.sene@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
LFB BIOMEDICAMENTS
Investigators
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Principal Investigator: Damien SÈNE Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03509064     History of Changes
Other Study ID Numbers: NI17025J
2017-A02858-45 ( Other Identifier: IDRCB )
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Primary sjogren syndrome
Small fiber neuropathy
Quality of life
Medico-economic impact
Additional relevant MeSH terms:
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Sjogren's Syndrome
Dry Eye Syndromes
Peripheral Nervous System Diseases
Small Fiber Neuropathy
Neuromuscular Diseases
Nervous System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases