谁在进行临床试验？
Hoffman La-Roche (also referred to as Roche or Roche Genentech) is conducting the study.
临床试验的目的是什么？
MANOEUVRE is a Phase 2 study of a medicine called RO7204239 (also called GYM329). The purpose of the study is to:
药物如何发挥作用？
FSHD causes muscle cells to die. RO7204239 blocks a protein in the muscles called myostatin. Myostatin controls muscle growth. Therefore, blocking myostatin may help muscles grow. RO7204239 belongs to a class of medicines called antibody therapies.
是否会给一些人服用安慰剂而不是药物？
是的，这是一项安慰剂对照研究。部分患者将接受安慰剂而非药物。.
我是否知道自己服用的是药物还是安慰剂？
不，你不会知道。这是一项双盲研究。患者和研究小组不会知道谁服用了药物，谁服用了安慰剂。.
如何给药？
RO7204239 and the placebo will be given as an injection under your skin, using a small needle in your abdomen. You will receive an injection every 4 weeks for 1 year.
临床试验需要多长时间？
Patients will complete a 4-week pre-treatment period to collect movement data with a wearable device. Then, patients will take the medicine (or placebo) for 1 year. At this time, you will have the option to take part in an active treatment extension. If you do 不 take part in the extension, you part in the study would take about 13 months.
Please see “What to Expect if You Enroll” for more information about the extension.
参加临床试验的标准是什么？
你必须
研究小组将对您进行以下评估
What criteria would exclude me from the clinical trial?
如果您有以下情况，将无法参加比赛
我是否需要进行基因测试才能加入？如果需要，是否会提供？
Yes, you must have a genetic test. If you don’t have one, the study team may be able to help you get one. However, the study will not pay for your genetic test.
We recommend you work with your doctor to start the process of getting a genetic test before trying to join this clinical trial. Genetic testing can take many weeks to complete. Because of this, the study team will likely give priority to patients who are already tested, or who have already started the process. Learn more about genetic testing.
研究小组如何确定我能否参加研究？
第一步通常是通过电话进行预选，了解申请资格标准。研究机构的协调员会给您打电话。初次通话后，协调员可能会要求您完成其他预选步骤。如果您符合条件，您的协调员将为您安排一次面对面的筛查访问。.
Your screening visit will take place at a study site. At this visit, you will learn more about the study and provide your consent to proceed. Then, the study team will perform all the tests needed to determine if you can take part in the study. This could take several hours, or you may need multiple visits. After all your test results come back, the study team will tell you whether you can take part in the study. This screening process can take up to 4 weeks.
我需要参加哪些活动？
研究访问有多少次？是面对面的还是虚拟的？
You will attend a study visit every 4 weeks to receive your medicine. You will also attend longer study visits every 6 months. Sometimes, these longer visits can be broken down toseveral shorter visits over a couple days. This will depend on your study site and what you prefer.
我是否需要在探访时过夜？
An overnight stay is not required for the study. However, if you are traveling from a long distance or prefer to break a longer visit into several shorter visits, you may decide to stay overnight in a hotel near your study site. You should talk to your study team about your travel needs.
临床试验结束后，会向患者提供这种药物吗？
Yes. After 4 weeks of pre-treatment and 52 weeks of treatment, you will have the option to take part in an active treatment extension. This is an additional period where all patients receive the medicine, even if you were previously on the placebo. You can decide whether you want to do the active treatment extension.
我是否需要支付任何医疗费用？我的保险会收到账单吗？
No, all costs are paid for by Hoffman La-Roche.
我能报销差旅费吗？
Yes, you will be reimbursed for travel costs needed to attend study visits. However, this will depend on local regulations. You should talk to your study team about your travel needs. Roche is committed to helping patients with travel costs.
谁来支付临床试验的费用？
Hoffman La-Roche is paying for the study.
需要多少志愿者？
The study needs 48 patients. However, many more volunteers are needed because not everyone who volunteers will be eligible and able to take part.
开展临床试验的研究机构在哪里？
The study is conducted across a few locations in Denmark, Italy, the United Kingdom, and the United States. To find specific sites, visit the Roche For Patients website 或临床试验 and click on the triangle shape to open up a list of locations. More locations may open as the study progresses.
如何联系我的学习地点以了解更多信息并注册？
To find specific sites, visit the Roche For Patients website 或 临床试验 and click on the triangle shape to open up a list of current locations.
If your study site is marked as “Recruiting,” there should be an email and/or phone number listed for contact. Sometimes there is also contact information listed for sites that are “Not Yet Recruiting.” You should email and call these contacts and let them know that you are interested in the MANOEUVRE study. If you are able and willing to travel to multiple different sites, you should contact each site individually.
与研究机构联系后会发生什么？
可能需要数周或数月才能收到回复，请耐心等待。研究机构可能仍在为研究做准备，可能还无法与任何人取得联系。有时，研究机构会因为有更多感兴趣的患者而招收不过来。请确保提供您的电子邮件和电话号码，以便协调员更容易与您联系。您还应坚持每月报到一次，这有助于研究小组了解您对完成临床试验的承诺。.
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