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Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies (TINISS)

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ClinicalTrials.gov Identifier: NCT03700138
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

To summarise, the peripheral neurological complications experienced by patients with primary Sjögren's syndrome are particularly bothersome since they are common and often result in significant disability related to pain or motor impairment. There is currently no standard treatment for these patients.

As these neuropathies are caused by an immune system dysfunction, which is related to a variety of different pathogenic mechanisms, the use of immunosuppressant or immunomodulator drugs is often justified.

With the exception of the vascularitis-related multiplex mononeuropathies, other pSS-related neuropathies could be suitable candidates for IV Ig treatment.


Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Painful Sensory Neuropathies Drug: Privigen® 100mg/ml at the dose of 2g/kg of body weight Drug: NaCl 0,9% Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rhophylac

Arm Intervention/treatment
Experimental: Privigen
TThe treatment (IV Ig, 100mg/ml at the dose of 2g/kg of body weight) will be administered by perfusion every 6 weeks, with a total of 3 perfusions administered (W0, W4, W8).
Drug: Privigen® 100mg/ml at the dose of 2g/kg of body weight
The treatment (IV Ig, 100mg/ml at the dose of 2g/kg of body weight) will be administered by perfusion every 4 weeks, with a total of 3 perfusions administered (W0, W4, W8).

Placebo Comparator: Placebo
The treatment (NaCl 0,9% 20 ml/kg) will be administered by perfusion every 4 weeks, with a total of 3 perfusions administered (W0, W4, W8).
Drug: NaCl 0,9%
The treatment (NaCl 0,9% 20 ml/kg) will be administered by perfusion every 4 weeks, with a total of 3 perfusions administered (W0, W4, W8).




Primary Outcome Measures :
  1. Improvement of at least 20% over placebo of numerical Pain Scale [ Time Frame: At week 11 ]
  2. Improvement of at least 20% over placebo with the R-DS scale (Rasch-built Overall Disability Scale) [ Time Frame: At week 11 ]

Secondary Outcome Measures :
  1. Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]
    o Quality of life scale (SF 36)

  2. Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]
    o HAD depression score

  3. Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]
    o Numerical Fatigue Scale

  4. Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]
    o A fatigue scale (EMIF)

  5. Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity. [ Time Frame: Weeks 11 ]
    o Numerical Dry mouth Scale

  6. Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. intensity. [ Time Frame: Weeks11 ]
    o Numerical Dry eye Scale

  7. Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]
    o ESSPRI

  8. Evaluate patient's quality of life, fatigue, and Sicca syndrome intensity. [ Time Frame: Weeks 11 ]
    o ESSDAI

  9. Evaluate intensity of the IV Ig effect on neurological scales [ Time Frame: Weeks 11 ]
    o Overall Neuropathy Limitations Scale (ONLS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years and < 80 years
  • Primary Sjögren's syndrome defined as per the European and American criteria (5)
  • Peripheral neuropathy clinically defined:

    • Pure sensitive (lymph node disease) or sensorimotor neuropathies with INCAT score of at least 2
    • Proved EMG
  • Renal function, and viral evaluation (VIH and hepatitis serology) :

    *Clairance > 50 (In case of biological abnormality, the second dosage can be scheduled within 2 weeks)

  • Effective contraception during the study period
  • Patient capable of understanding information about the study and of giving his/her consent
  • Patient informed of the preliminary medical exam results
  • Patient with healthcare insurance
  • Written consent signed

Exclusion Criteria:

  • Peripheral neurological damage of the type vascularitis-related multiplex mononeuropathy
  • Small fibers neuropathy
  • Neuropathy suspected of being related to alcohol, diabetes or post-chemotherapy
  • Chronic viral infection (HCV, HBV, HIV, etc.)
  • Prior treatment with polyvalent intravenous immunoglobulins in the 6 months preceding the study
  • Corticosteroid treatment at a dose greater than 20 mg/d of prednisone equivalent or no stable dose for at least 1 month before inclusion
  • Conventional immunosuppressant treatment with azathioprin, cyclophosphamide or mycophenolate mofetil on-going or interrupted less than one month before inclusion
  • Rituximab or other biotherapy (belimumab, tocilizumab, …) less than 6 months before the start of the study treatment
  • Immunomodulating treatment with methotrexate no stable dose for at least 2 months before inclusion
  • Hydroxychloroquine no stable dose for at least 3 months before inclusion
  • Pilocarpine hydrochloride secretagogue treatment no stable dose for at least one month before inclusion
  • Treatment with amitriptyline, clomipramine, carbamazepine, clonazepam, pregabaline, duloxetine or gabapentine if the dose has not been stable for at least one month before inclusion (possible dose reduction to be documented).
  • renal clairance < 50 ml/mn
  • HIV seropositivity
  • HBV, or HCV viral replication
  • Contraindication to the use of IV Ig: h Hypersensitivity to the active substance or to any of the excipients; hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA; patients with hyperprolinaemia.
  • Contraindication to the use of Nacl
  • Immunization with live attenuated vaccine within 2 weeks prior to inclusion
  • Participation in a clinical study with an investigational product with an exclusion period
  • Women of child bearing potential or intends to become pregnant, unless they are using an effective method of birth control* and a βHCG blood test negative
  • Pregnant or nursing (lactating) women
  • Patient under legal guardianship
  • Prisoners

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): NCT03700138


Contacts
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Contact: Jacques-Eric GOTTENBERG, MD 03 88 12 79 53 ext 0033 jacques-eric.gottenberg@chru-strabourg.fr
Contact: Jérôme DE SEZE, MD 03 88 12 85 43 ext 0033 Jerome.DESEZE@chru-strasbourg.fr

Locations
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France
University Hospital, Strasbourg, france Recruiting
Strasbourg, France, 67000
Contact: Jacques -Eric Gottenberg, MD    03 88 12 79 53 ext 0033    jacques-eric.gottenberg@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Jacques-Eric Jacques-Eric, MD University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03700138     History of Changes
Other Study ID Numbers: 6621
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Dry Eye Syndromes
Pain
Disease
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
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
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs