Observational Study of Golimumab Intravenous Infusion (GO-IV)
2016年11月16日 更新者:Janssen Inc.
Golimumab Intravenous Infusion Registry (GO-IV)
The purpose of this study is to evaluate the incidence and management of infusion reactions with Golimumab intravenous infusion.
研究概览
详细说明
This is a prospective, observational, non-interventional (no treatment given during course of the study) multi-center (when more than one hospital or medical school team work on a medical research study), study that will enroll participants with rheumatoid arthritis (RA) in Canada.
Only data available from source documentation will be collected.
The participation in this study will not impact on the standard of care of the participant or any benefits to which they are otherwise entitled.
All aspects of treatment decisions and clinical management of participants will be in accordance with clinical practice and at the discretion of the health care provider.
Participants' safety will be monitored throughout the study.
研究类型
观察性的
注册 (实际的)
78
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
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Victoria、加拿大
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Newfoundland and Labrador
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Saint-John'S、Newfoundland and Labrador、加拿大
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Ontario
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Ancaster、Ontario、加拿大
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Barrie、Ontario、加拿大
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Kitchener、Ontario、加拿大
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Mississauga、Ontario、加拿大
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Nepean、Ontario、加拿大
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Oakville、Ontario、加拿大
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St.Catharines、Ontario、加拿大
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Toronto、Ontario、加拿大
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Quebec
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Laval、Quebec、加拿大
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Montreal、Quebec、加拿大
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Saskatchewan
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Saskatoon、Saskatchewan、加拿大
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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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Canadian participants with rheumatoid arthritis (RA), who have been prescribed intravenous golimumab prior to, and independently of, study enrollment.
描述
Inclusion Criteria:
- Participants must have a confirmed diagnosis of rheumatoid arthritis
- Participants must have provided a written consent for data collection by signing an informed consent form indicating that he/she understand the purpose and procedures for data collection and are willing to participate in the study
- Participants are golimumab-naive (never have used golimumab both SC and IV formulations)
- Participants are prescribed golimumab intravenous by an appropriate physician as per the Canadian Product Monograph
Exclusion criteria:
- Participant who has been treated with golimumab in the past
- Participant has been diagnosed with psoriatic arthritis or ankylosing spondylitis
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study or first data collection time point
- Participant is currently enrolled in an interventional study
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
队列和干预
团体/队列 |
干预/治疗 |
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Golimumab Intravenous
Participants with rheumatoid arthritis (RA) in Canada, will be observed for 24 months.
Only data available from source documentation will be collected.
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This is a non-interventional study.
Participants with rheumatoid arthritis in Canada will be observed for 24 months.
其他名称:
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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 |
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Number of Participants With Infusion Reactions
大体时间:Up to end of study (2 years) or early withdrawal
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The count of infusion reactions will be reported.
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Up to end of study (2 years) or early withdrawal
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Number of Participants With use of Pre-infusion Medications
大体时间:Baseline up to end of study (2 years) or early withdrawal
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Participants with administration of Pre-infusion medications or combination of Pre-infusion medications will be reported.
The list of pre-treatments includes: acetaminophen, anti-histamines, steroids (Hydrocortisone, Prednisone), acetaminophen alone, anti-histamines alone, steroids alone, steroids + anti-histamines, steroids + acetaminophen, anti-histamines + acetaminophen, steroids + anti-histamines + acetaminophen.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With use of Concomitant Medications at Time of Infusion
大体时间:Baseline up to end of study (2 years) or early withdrawal
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Participants with type of concomitant medications used at time of infusion will be reported.
The groups of concomitant medication of interest are: any immunosuppressant (IS), methotrexate and corticosteroids.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With Infusion Reaction Treatments
大体时间:Baseline up to end of study (2 years) or early withdrawal
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For each infusion administration with infusion reactions, type of medications was used to treat the reaction will be reported.
The list of medications includes anti-histamines, steroids, and epinephrine.
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Baseline up to end of study (2 years) or early withdrawal
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Number of Participants With Subsequent Reactions After the First Infusion Reaction
大体时间:Baseline up to end of study (2 years) or early withdrawal
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For each participant who has experienced at least 1 infusion reaction after enrolment, occurrence of infusion reaction at subsequent infusions after the first infusion reaction will be assessed.
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Baseline up to end of study (2 years) or early withdrawal
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Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score
大体时间:Baseline up to end of study (2 years) or early withdrawal
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The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping).
Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale.
Each domain also has a specific weight assigned by a patient survey.
The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).
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Baseline up to end of study (2 years) or early withdrawal
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Percentage of Participants With Absolute Change of at Least 3 Points in RAID Score
大体时间:Baseline up to end of study (2 years) or early withdrawal
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The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping).
Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale.
Each domain also has a specific weight assigned by a patient survey.
The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).
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Baseline up to end of study (2 years) or early withdrawal
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Percentage of Participants With Relative Change of at Least 50 Percent (%) and a Maximum Score of 2 in RAID Score
大体时间:Baseline up to end of study (2 years) or early withdrawal
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The RAID is self-administered questionnaire which includes seven domains (pain, function, fatigue, physical and psychological wellbeing, sleep disturbance and coping).
Each domain is evaluated using a single question answered by a 0 to 10 numerical rating scale.
Each domain also has a specific weight assigned by a patient survey.
The RAID score is a continuous variable ranging from 0 (best) to 10 (worst).
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Baseline up to end of study (2 years) or early withdrawal
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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
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
2015年2月1日
初级完成 (实际的)
2016年10月1日
研究完成 (实际的)
2016年10月1日
研究注册日期
首次提交
2015年3月11日
首先提交符合 QC 标准的
2015年3月11日
首次发布 (估计)
2015年3月17日
研究记录更新
最后更新发布 (估计)
2016年11月17日
上次提交的符合 QC 标准的更新
2016年11月16日
最后验证
2016年11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.
Golimumab Intravenous的临床试验
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Merck Sharp & Dohme LLC完全的
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Vastra Gotaland Region主动,不招人