Prospective, randomised, placebo-controlled study of polyvalent intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies

Prior treatment

• Participation in a clinical study with an investigational product with an exclusion period
• Concomitant medications : • Prior treatment with polyvalent intravenous immunoglobulins in the 6 months preceding inclusion the study • Conventional immunosuppressant treatment with azathioprin, cyclophosphamide or mycophenolate mofetil on-going or interrupted less than one within one month before inclusion • Rituximab or other biotherapy (belimumab, tocilizumab, …) treatment within 6 months before the start of the study treatment inclusion • Corticosteroid treatment administered at a dose greater than > 20 mg/day of prednisone equivalent or administered at a non-stable dose <20 mg/day within the for at least 1 month before inclusion (Corticosteroid treatment administered at a stable dose < 20 mg/day for at least one month prior to inclusion is allowed) • Immunomodulating treatment with by methotrexate at a non-stable dose within for at least 2 months before inclusion (Immunomudulating treatment by methotrexate given at a stable dose for at least 2 months prior to inclusion is allowed) • Treatment by Hydroxychloroquine at a non-stable dose within for at least 3 months before inclusion (Treatment by Hydroxychloroquine given at a stable dose for at least 3 months prior to inclusion is allowed) • Pilocarpine hydrochloride secretagogue treatment at a non-stable dose within for at least one month before inclusion (Pilocardine hydrochloride secretagogue given at a stable dose for at least one month XML File Identifier: CtM2lMg6Da8T7bFdY61LAfMVsX4= Page 12/27 prior to inclusion is allowed) • Treatment by amitriptyline, clomipramine, carbamazepine, clonazepam, pregabaline, duloxetine or gabapentine at a non-stable dose within if the dose has not been stable for at least one month before inclusion (possible dose reduction to be documented) (Treatment by amitriptyline, clomipramine, carbamazepine, clonazepam, pregabaline, duloxetine or gabapentine given at a stable dose for at least one month prior to inclusion is allowed).
• Immunization with live attenuated vaccine within 2 weeks prior to inclusion

Other illness

• Neuropathy suspected of being related to alcohol, diabetes or postchemotherapy
• Chronic viral infection (HCV, HBV, HIV, etc.)
• 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.
• Patients at high risk of thromboembolism and patients with history of thromboembolic event without anticoagulant treatment

Other

• Peripheral neurological damage of the type vascularitis-related multiplex mononeuropathy
• 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
• Small fibers neuropathy
• Contraindication to the use of NaCl

• Age ≥ 18 years and < 80 years
• -Primary Sjögren's syndrome defined as per the European and American criteria
• -Peripheral neuropathy clinically defined: *Pure sensitive (lymph node disease) or sensorimotor neuropathies *Proved EMG
• -Renal function, and viral evaluation (VIH and hepatitis serology) : *Clairance > 50 ml/min/1,73m2 (MDRD) (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