NCT00667758已完成2 期
Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of gonadotropin-releasing hormone (GnRH) antagonist therapy versus placebo in patients with moderate to severe rheumatoid arthritis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult between 18 years and above
- •Moderate to severe disease activity
- •Negative pregnancy test for women of childbearing potential
- •Use of reliable method of contraception (non-hormonal) by sexually active female patients
排除标准
- •Patients who are pregnant or breastfeeding
- •Patients taking biologic therapy or prednisolone >7.5mg
研究组 & 干预措施
1
Experimental
Cetrorelix
干预措施: Cetrorelix (Drug)
2
Placebo Comparator
NaCl solution
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Disease Activity Score (DAS28CRP) in cetrorelix group versus placebo group
时间窗: From baseline to day 5
次要结局
- Change in cytokine level(From baseline to day 2/5/10/15)
- Change in DAS28 (CRP/ESR)(From baseline to day 2/5 /10/15)
- Proportion of patients with ACR 20/50/70/90 and EULAR good/moderate/none responders(Baseilne to day 2/5/10/15)
- Proportion of patients with DAS28low disease activity/remission(Baseline to day 2/5/10/15)
- Change in HAQ scores(From baseline to day 5/10/15)
- Change in anti-CCP level(From baseline to day 2/5/10/15)
- Correlation between percent changes in hormones, disease activity and biomarkers(By day 2, 5, 10 and 15)
- Change in ACR core set measures(From baseline to day 2/5/10/15)
- Adverse events(Baseline up to day 15)
研究者
Anita Kass
Dr Anita Kåss
Betanien Hospital
研究点 (1)
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