Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients
2013年6月26日 更新者：Galapagos NV
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone
- Ninety patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will be evaluated for improvement of disease activity when taking GLPG0634 (4 different doses will be evaluated) or matching placebo for 4 weeks.
- During the course of the study, patients will also be examined for any side effects that may occur, and the amount of GLPG0634 present in the blood as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood will be determined.
研究概览
研究类型
介入性
注册 (实际的)
91
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Chernivtsi、乌克兰
- Chernivtsi Regional Clinical Hospital
-
Donetsk、乌克兰
- State Institution 'Institute of Urgent and Recovery Surgery n.a. V.K. Gusaka' of AMS of Ukraine
-
Kharkiv、乌克兰
- Communal Institution of Healthcare
-
Kharkiv、乌克兰
- Institution of Therapy of AMS of Ukraine
-
Kharkiv、乌克兰
- State Institution 'Institute of Microbiology and Immunology of AMS of Ukraine'
-
Kiev、乌克兰
- State Institution 'Republican Clinical Hospital of MoH of Ukraine'
-
Lutsk、乌克兰
- Lutsk City Clinical Hospital
-
Vinnytsa、乌克兰
- Vinnytsa Regional Clinical Hospital
-
Zaporizhzhia、乌克兰
- Zaporizhzhia Regional Clinical Hospital
-
-
-
-
-
Moscow、俄罗斯联邦
- State Healthcare Institution of city Moscow 'City Clinical Hospital #7'
-
Ryazan、俄罗斯联邦
- State Healthcare Institution 'Ryazan Regional Cardiology Dispensary'
-
Saint-Petersburg、俄罗斯联邦
- Saint-Petersburg State Healthcare Institution 'City Hospital #26'
-
Saint-Petersburg、俄罗斯联邦
- Saint-Petersburg State Healthcare Institution 'City Mariinskiy Hospital'
-
Yaroslavl、俄罗斯联邦
- Municipal Clinical Healthcare Institution 'Medical-Sanitary Unit of Novoyaroslavskiy Oil Refinery'
-
-
-
-
-
Budapest、匈牙利
- Budai Irgalamsrendi Korhaz, II. Reumatologia Osztaly
-
Budapest、匈牙利
- Orszagos Reumatologiai es Fizioterapias Intezet, I. Reumatologia Osztaly
-
Eger、匈牙利
- Markhot Ferenc Korhaz, Reumatologiai Osztaly
-
Kistarcsa、匈牙利
- Pest Megyei Flor Ferenc Korhaz, Reumatologiai es Fizioterapias Osztaly
-
-
-
-
-
Chisinau、摩尔多瓦共和国
- IMSP Institutel de Cardiologie
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Have active RA as shown by five or more swollen joints (from the 66-joint count), five or more tender joints (from 68-joint count), and a serum CRP ≥1.0 mg/dL;
- Have received methotrexate for 12 weeks or longer and at a stable dose of 7.5 to 25 mg/week for at least 4 weeks prior to screening and willing to continue on this regimen for the duration of the study;
- If taking oral steroids, these should be at a dose ≤10 mg/day of prednisone or prednisone equivalent and stable for at least 4 weeks prior to screening;
- If taking non-steroidal anti-inflammatory drugs (NSAIDs), these must be at a stable dose for at least 2 weeks prior to screening;
- Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year;
- Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study drug.
- Sexually active men must agree to use a medically acceptable form of contraception during the study and continue its use for at least 3 months after the last dose of study drug; and
- Able and willing to sign the informed consent prior to screening evaluations and agree to schedule of assessments.
Exclusion Criteria:
- Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background methotrexate;
- Current or previous RA treatment with a biological agent, with the exception of biologics administered in a clinical study setting more than six months prior to screening (12 months for rituximab or other B cell depleting agents);
- Previous treatment at any time with a cytotoxic agent, other than methotrexate, before screening;
- Previous use of the study drug GLPG0634;
- Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to screening;
- Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator;
- Positive serology for HIV1 or 2 or hepatitis B or C, or any history of hepatitis from any cause with the exception of hepatitis A;
- History of any inflammatory rheumatological disorders other than RA;
- History of tuberculosis (TB) infection
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：capsule, 30mg GLPG0634 once a day
3 capsules of 10 mg once a day
|
|
|
实验性的：capsules, 75mg GLPG0634 once a day
3 capsules of 25mg once a day
|
|
|
实验性的：capsules, 150mg GLPG0634 once a day
3 capsules of 50mg once a day
|
|
|
实验性的：capsules, 300mg GLPG0634 once a day
3 capsules of 100mg once a day
|
|
|
安慰剂比较：capsules, placebo once a day
3 capsules placebo once a day
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The number of patients with an ACR20 score at Week 4 as a measure of efficacy
大体时间：Week 4 (end of treatment visit)
|
To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4
|
Week 4 (end of treatment visit)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The number of patients with ACR20/50/70 response, time to response and DAS28 score at every visit as a measure of efficacy
大体时间：From Day -1 up to end of treatment visit (week 4)
|
To evaluate the efficacy of GLPG0634 compared to placebo in terms of ACR response criteria at every visit (ACR20, ACR50, ACR70), time to response, and disease status (DAS28[C-reactive protein, CRP]
|
From Day -1 up to end of treatment visit (week 4)
|
|
The number of patients with adverse events, abnormal lab tests, vital signs and ECG as a measure of safety and tolerability
大体时间：From screening up to 10 days after last dose
|
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo in terms of adverse events (AEs), laboratory test abnormalities, vital signs and electrocardiogram (ECG)
|
From screening up to 10 days after last dose
|
|
The plasma levels of GLPG0634 as a measure of PK
大体时间：Week 1, week 2 and week 4 visits
|
To characterize the pharmacokinetics (PK) of GLPG0634 by measuring the amount of GLPG0634 in the plasma
|
Week 1, week 2 and week 4 visits
|
|
The plasma levels of GLPG0634 and MTX as a measure of PK
大体时间：Day -1 and Week 2 or 4 visit (8 hour-sampling)
|
To explore the potential interaction of GLPG0634 on MTX by assessing steady state PK in an 8-hour sampling at Day -1 and at Week 2 or Week 4 visit in a subset of patients
|
Day -1 and Week 2 or 4 visit (8 hour-sampling)
|
|
The levels of immune- and inflammation-related parameters in plasma as a measure of PD
大体时间：Day -1, Week 1, week 2 and week 4 visits
|
To characterize the pharmacodynamics (PD) of GLPG0634 by measuring the levels of immune- and inflammation-related parameters in plasma
|
Day -1, Week 1, week 2 and week 4 visits
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年5月1日
初级完成 (实际的)
2012年9月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2012年8月14日
首先提交符合 QC 标准的
2012年8月16日
首次发布 (估计)
2012年8月20日
研究记录更新
最后更新发布 (估计)
2013年6月27日
上次提交的符合 QC 标准的更新
2013年6月26日
最后验证
2013年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.