PER-035-16招募中未知
A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate theEfficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjogren´s Syndrome
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subjects diagnosed or classified as having moderate to severe primary Sjögren’s syndrome based on the 2015 ACR-EULAR Classification Criteria for Sjögren’s syndrome, with disease duration from time since diagnosis of at least 16 weeks, but not more than 7 years prior to the Screening Visit
- •2. ESSDAI ≥ 5; including disease activity (any score > 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
- •3. Positive anti-SS-A/Ro or anti-SS-B/La autoantibody
- •4. Unstimulated whole saliva secretion > 0.01 mL/min
排除标准
- •Sujetos con:
- •1.Sindrome de Sjögren secundario.
- •2.Otras enfermedades autoinmunes sistemicas
- •3.Una afeccion que podria confundir el diagnostico de pSS,
- •4.pSS muy severo o complicaciones severas de pSS
- •5.Infeccion aguda de las glandulas salivales
- •6.Riesgo de tuberculosis (TB), infeccion bacteriana o infecciones fungicas sistemicas.
- •7.Sintomas de herpes zoster o evidencia de infeccion bacteriana o viral activa o latente.
- •8.Intervencion quirurgica mayor o cirugia programada.
- •9.Que reciben hidroxicloroquina y no tiene documentacion de una evaluacion oftalmologica.
- •10.Donacion de sangre o transfusion de sangre dentro de las 4 semanas.
- •11.Incapacidad para tolerar la venipuncion y/o el acceso venoso.
- •12.Antecedentes conocidos de abuso de drogas o alcohol o de incumplimiento con el tratamiento medico.
- •13.Administracion de vacunas de virus vivos.
- •14.Sujetos que no estan dispuestos o tienen dificultad para tragar comprimidos orales.
- •15.Resultados positivos para HBsAg o anti-HBc o TB IGRA, hepatitis C o para VIH.
- •16.Corticosteroides orales > 10 mg/dia o intravenosos, intramusculares o intra-articulares.
研究者
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