Primary Sjögren's syndrome associated painful sensory neuropathies
Conditions
Interventions
Trade Name: Privigen 100 mg/ml, solution pour perfusion
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: I
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age = 18 years and 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: -Peripheral neurological damage of the type vascularitis-related multiplex mononeuropathy -Small fibers neuropathy -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). -Contraindication to the use of IV Ig 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 ßHCG blood test negative -Pregnant or nursing (lactating) women -Patient under legal guardianship -Prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the subjective or objective efficacy of IV Ig in the treatment of primary Sjögren's syndrome-related peripheral neuropathies;Secondary Objective: 1)Evaluate patient’s quality of life, fatigue, and Sicca syndrome intensity. 2)To evaluate intensity of the IV Ig effect on neurological scales 3)Evaluate the treatment’s safety with regard to patient benefit ;Primary end point(s): Improvement of at least 20% over placebo in one of the following 2 scales, 3 weeks after the last treatment course : -Objective neurological criterion using the R-ODS scale (Rasch-built Overall Disability Scale) -Numerical Pain Scale ;Timepoint(s) of evaluation of this end point: Week 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Primary Sjögren's Syndrome Criteria oQuality of life scale (SF 36) oHAD depression score oNumerical Fatigue Scale oA fatigue scale (EMIF) oNumerical Dry mouth Scale oNumerical Dry eye Scale oFlow of saliva (non stimulated) oESSPRI oESSDAI 2) Neurological criteria oOverall Neuropathy Limitations Scale (ONLS) 3) Adverse reactions rate ;Timepoint(s) of evaluation of this end point: Weeks 0,6,12,15 | — |
Countries
France
Contacts
Public ContactArmelle DREXLER
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed