Intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies

Phase 1

• Conditions: Primary Sjögren's syndrome associated painful sensory neuropathies; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-001371-24-FR
• Lead Sponsor: Hôpitaux Universitaires de Strasbourg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-15
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

-Age = 18 years and < 80 years
-Primary Sjögren's syndrome defined as per the European and American criteria
-Peripheral neuropathy clinically defined:
*Sensory 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
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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified