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临床试验/EUCTR2006-003142-42-DE
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

4SC AG0 个研究点目标入组 120 人2007年2月2日

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。

注册库
who.int
开始日期
2007年2月2日
结束日期
待定
最后更新
14年前
研究类型
Interventional clinical trial of medicinal product
性别
All

研究者

发起方
4SC AG

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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