Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire (ARMS)
Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire - A Phase 4 Pilot Study
This Phase 4 pilot cross-sectional descriptive/exploratory study is to be conducted in clinical practice settings (including MS (Multiple sclerosis) specialty clinics, general neurology practices, or other academic or private practice settings) in the United States to assess the psychometric properties of the ARMS questionnaire in approximately 100 adult patients with MS who are experiencing a confirmed relapse, as identified by the investigator or designee at each site. Neither efficacy nor safety of treatment will be evaluated in this study.
The ARMS questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1 page. Part 1 is designed to evaluate the patient's relapse symptoms and how the symptoms affect daily activities and overall function, as well as patient's response to past treatments for previous relapses, as a means of guiding treatment selection. Part 2 is designed to evaluate treatment response in terms of symptom relief and functioning, as well as treatment tolerability. Part 1 of the survey is to be completed when the patient presents with new relapse of MS. Part 2 of the survey is to be completed 1 month (± 1 week) after initiation of treatment for relapse of MS. Treatment for relapse will be at the sole discretion of the investigator.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国
- Tanner Center and Foundation for MS
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California
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Oceanside、California、美国
- Neurology Center
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Florida
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Hollywood、Florida、美国
- Infinity Clinical Research
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Orlando、Florida、美国
- McCare Center Neurology Services
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Virginia
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Fairfax、Virginia、美国
- Neurology Center of Fairfax
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Informed consent and HIPAA authorization must be obtained from the patient prior to any study-related procedures.
- Patient is ≥ 18 years of age at the time of participation
- Patient has confirmed MS relapse.
- Patient must have been treated with oral or IV corticosteroids for their previous relapse.
- Willingness to comply with all procedures and assessments.
Exclusion Criteria:
- Patient has pseudorelapse.
- Patient was treated with any therapies other than corticosteroids for their previous relapse.
- Any other condition which, in the opinion of the investigator, would not allow proper completion of this study.
学习计划
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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ARMS Questionnaire Group
Patients with confirmed multiple sclerosis relapse who are willing to participate in the ARMS questionnaire.
These patients could not have been treated with any therapies other than oral or intravenous corticosteroids for their previous relapse.
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The ARMS Questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1 page.
Eligible patients will be administered part 1 of the survey when the patient presents with new relapse.
Part 2 of the survey is to be completed 1 month (± 1 week) after initiation of treatment for relapse.
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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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Total Composite Score (TCS)
大体时间：After relapse treatment (1 month ± 1 week)
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Total composite score is calculated from three interrelated questions on part 2 of the ARMS questionnaire (to be completed 1 month ± 1 week after relapse treatment).
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After relapse treatment (1 month ± 1 week)
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- QSC02-ARMS-01
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.
ARMS Questionnaire的临床试验
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First People's Hospital of Hangzhou完全的
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University of Toledo Health Science CampusProMedica Health System; The University of Toledo; ARMS Pharmaceutical LLC; Pediatric Pharmacology...撤销
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Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin招聘中