EUCTR2006-003142-42-DE
进行中(未招募)
不适用
A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Active Rheumatoid Arthritis
- 发起方
- 4SC AG
- 入组人数
- 120
- 状态
- 进行中(未招募)
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •6\.2Subject Inclusion Criteria
- •Subjects meeting all of the following inclusion criteria will be considered for admission to the trial:
- •1\.Regarding demographic data:
- •Age:From 18 years
- •Gender:Males and females
- •Race:Caucasian
- •BMI:19 \- 30 kg/m2
- •2\.Regarding RA:
- •Patients with early active RA of functional classes I, II or III according to the criteria of American Rheumatism Association for RA
- •DAS28(CRP) \= 4\.1
排除标准
- •6\.3Subject Exclusion Criteria
- •Subjects presenting any of the following exclusion criteria cannot be admitted to the trial:
- •1\.Regarding RA:
- •Patients with RA of functional classes IV according to the criteria of American Rheumatism Association for RA
- •2\.Regarding pre\-treatment of RA and concomitant medication:
- •History of treatment with one of the following drugs:
- •Leflunomide
- •Oral or injectable gold
- •Cyclophosphamide
- •Biologicals
结局指标
主要结局
未指定
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