EUCTR2015-004476-30-GB进行中（未招募）1 期
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •-Males and females 18 to 75 years of age
- •-Primary Sjögren's syndrome diagnosed previously according to the revised American-European Consensus Group (AECG) criteria
- •-European League against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score >= 5
- •-EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score >= 5
- •-Elevated serum titres at screening of anti-Sjögren's-syndrome-related antigen A (anti-SSA) and/or anti-SSB antibodies at screening
- •-Negative pregnancy test at screening and baseline, and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-A diagnosis of secondary Sjögren's syndrome according to the revised AECG criteria
- •-Severe complications of Sjögren's syndrome, such as vasculitis with renal, neurologic or cardiac involvement; interstitial lung disease and severe myositis
- •-Systemic immunosuppressant therapy, cyclophosphamide or B cell depleting therapy within 6 months prior to the screening visit. Low dose methotrexate treatment is, however, permitted
- •-Corticosteroid therapy exceeding 7.5 milligram (mg) prednisone equivalents per day
- •-Mechanically stimulated whole salivary flow rate at baseline of < 0.1 millilitre/minute (mL/min)
- •-A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at the screening visit
- •-A history of recurring or chronic infections, any other indication of reduced immune function, or any other underlying conditions which may predispose participants to serious infection
- •-A history of lymphoma, myeloma (monoclonal hypergammaglobulinemia) or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years (except basal cell or squamous cell carcinoma of the skin that has been cured)
- •-A diagnosis of fibromyalgia, or a diagnosis of significant depression or anxiety that would confound the interpretation of the study results
- •-Severe renal impairment, moderate or severe hepatic impairment or other clinically significant hepatic disease
- •-Any other concomitant disease or condition or any clinically significant finding that could interfere with the conduct of the study, or pose an unacceptable risk to the individual in this study
- •-Participation in an investigational drug or device study within 3 months prior to screening
- •-Inability to comply with the study protocol for any other reason
- •-Women who are lactating.
- •-Use of other prohibited medication (moderate or potent inhibitors of CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp]; sensitive substrates of CYP3A4 with a narrow therapeutic index).
研究者
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