2024-517309-95-00已完成3 期
Prospective, randomised, placebo-controlled study of polyvalent intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- Improvement of at least 20% over placebo in one of the following 2 scales, 3 weeks after the last treatment course (week 11): - Objective neurological criterion using the R-ODS scale (Rasch-built Overall Disability Scale) - Numerical Pain Scale (0 to 10)
研究概览
简要总结
Demonstrate the subjective or objective efficacy of IV Ig in the treatment of primary Sjögren's syndrome-related peripheral neuropathies
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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: *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
排除标准
- •Peripheral neurological damage of the type vascularitis-related multiplex mononeuropathy
- •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
- •Small fibers neuropathy
- •Neuropathy suspected of being related to alcohol, diabetes or postchemotherapy
- •Chronic viral infection (HCV, HBV, HIV, etc.)
- •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).
- •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
- •Patients at high risk of thromboembolism and patients with history of thromboembolic event without anticoagulant treatment
结局指标
主要结局
Improvement of at least 20% over placebo in one of the following 2 scales, 3 weeks after the last treatment course (week 11): - Objective neurological criterion using the R-ODS scale (Rasch-built Overall Disability Scale) - Numerical Pain Scale (0 to 10)
Improvement of at least 20% over placebo in one of the following 2 scales, 3 weeks after the last treatment course (week 11): - Objective neurological criterion using the R-ODS scale (Rasch-built Overall Disability Scale) - Numerical Pain Scale (0 to 10)
次要结局
- 1) Primary Sjögren's Syndrome Criteria o Quality of life scale (SF 36) o HAD depression score o Numerical Fatigue Scale : score between 0 and 10 o A fatigue scale (EMIF) : o Numerical Dry mouth Scale : score between 0 and 10 o Numerical Dry eye Scale : score between 0 and 10 o Flow of saliva (non stimulated o ESSPRI (Eular Sjogren's Syndrome Patient Reported Index) o ESSDAI (Eular Sjögren Syndrome Disease Activity index)
- 2) Neurological criteria o Overall Neuropathy Limitations Scale (ONLS)
- 3) Adverse reactions rate
研究者
Pr Jacques-Eric GOTTENBERG
Scientific
Les Hopitaux Universitaires De Strasbourg
研究点 (8)
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