EUCTR2017-001371-24-FR进行中（未招募）1 期
Prospective, randomised, placebo-controlled study of polyvalent intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies - TINISS
Hôpitaux Universitaires de Strasbourg0 个研究点目标入组 24 人开始时间: 2018年10月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-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
排除标准
- •-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
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