NCT00747214已完成2 期
A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA
Zalicus0 个研究点目标入组 59 人开始时间: 2004年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 主要终点
- Change in CRP From Baseline to Day 42
研究概览
简要总结
This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).
详细描述
The primary objective of this study was to:
• Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.
The secondary objectives of this study were to:
- Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy.
- Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Was 18 years of age of older
- •Had moderate to severe RA
- •Had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28)
- •Had a Baseline CRP level of at least 2.2 mg/L and a DAS28 score >4.5
- •Had been on DMARD therapy for at least 3 months and have been on a stable dose of DMARD therapy for at least 28 days prior to enrollment
- •Had a negative pregnancy test (females)
- •Was not taking glucocorticoids at screening
排除标准
- •Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
- •Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
- •Subject is currently taking more than 81 mg of aspirin daily.
- •Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
- •Subject has any active infections or recent surgical procedures within 30 days of study initiation.
- •Subject has uncontrolled diabetes mellitus as defined by a HbA1C value ≥ 7.0%.
- •Subject knowingly has HIV or Hepatitis.
- •Subject has undergone administration of any investigational drug within 30 days of study initiation.
- •Subject has a history of hypersensitivity to steroids and/or dipyridamole.
- •Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
研究组 & 干预措施
CRx-102 plus DMARD therapy
Experimental
干预措施: CRx-102 (Drug)
CRx-102 plus DMARD therapy
Experimental
干预措施: DMARD Therapy (Drug)
Placebo plus DMARD therapy
Placebo Comparator
干预措施: Placebo (Drug)
Placebo plus DMARD therapy
Placebo Comparator
干预措施: DMARD Therapy (Drug)
结局指标
主要结局
Change in CRP From Baseline to Day 42
时间窗: Baseline and Day 42
The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.
次要结局
- Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)(Day 42)
- Change in DAS28 Score From Baseline to Day 42(Baseline and Day 42)
- Change in Fatigue (MAF Scale) Score From Baseline to Day 42(Baseline and Day 42)
研究者
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