Preference for Inebilizumab Infused at Home


Partners HealthCare System Research Consent Form

Principal Investigator: Michael Levy, MD, PhD
Description of Subject Population: Neuromyelitis Optica Spectrum Disorder

About this consent form

Please read this form carefully. It tells you important information about a research study. A member of our research team will also talk to you about taking part in this research study. People who agree to take part in research studies are called “subjects.” This term will be used throughout this consent form.

Partners HealthCare System is made up of Partners hospitals, health care providers, and researchers. In the rest of this consent form, we refer to the Partners system simply as “Partners.”

If you decide to take part in this research study, you must sign this form to show that you want to take part. We will give you a signed copy of this form to keep.

Key Information

Taking part in this research study is up to you. You can decide not to take part. If you decide to take part now, you can change your mind and drop out later. Your decision won’t change the medical care you get within Partners now or in the future.

The following key information is to help you decide whether or not to take part in this research study. We have included more details about the research in the Detailed Information section that follows the key information.

Why is this research study being done?

This research is being done to determine if home infusions of inebilizumab are favored over infusions at hospitals or infusion centers and if home infusions improve the quality of life of patients with Neuromyelitis optica spectrum disorder, or NMOSD.

How long will you take part in this research study?

If you decide to join this research study, it will take you about 1 year to complete the study. The study is being conducted remotely and will not require you to make study visits.

What will happen if you take part in this research study?

If you are in the Mass General Brigham (MGB) system, we have already determined that you are eligible to take part in the study. If you referred to this study by your local neurologist, we have reviewed your eligibility with your neurologist. Once you agree to participate and sign this consent form, we will schedule a remote Zoom visit to discuss the consent form, which provides details of the study. We will also request your clinical records from your doctor in order to track information such as your aquaporin-4 antibody status, previous treatment history and current treatment medications. This information will kept confidential with our team. We will only use your full name and date of birth to coordinate data transfer with the home infusion company involved in this study.

During the course of the 1 year study, we will check in with you every 6 months by Zoom and ask you to complete a short survey on your quality of life and preferences for home vs. infusion center infusions.

Why might you choose to take part in this study?

There are no meaningful benefits to participating in this study. Others with neuromyelitis optica spectrum disorder may benefit in the future from what we learn in this study.

Why might you choose NOT to take part in this study?

Taking part in this research study has some risks and requirements that you should consider carefully.

A detailed description of side effects, risks, and possible discomforts can be found later in this consent form in the section called "What are the risks and possible discomforts from being in this research study?” Another thing to consider is the time commitment required to participate in this study.

What other treatments or procedures are available for your condition?

You may be able to receive this infusion at your local hospital, doctor’s office or infusion center.

If you have questions or concerns about this research study whom can you call?

Michael Levy, MD, PhD is the person in charge of this research study. You can call him/her at 617-726-0412 during business hours or 410-979-8297 (cell) for urgent or emergent issues after hours. You can also call the study coordinator during regular business hours at 617-726-0412 with questions about this research study and for questions about the scheduling of appointments or study visits.

If you have questions or concerns about this research study, whom can you call?

You can call us with your questions or concerns. Our telephone numbers are listed below. Ask questions as often as you want.

Michael Levy, MD, PhD is the person in charge of this research study. You can call him at 617- 726-0412 during business hours or 410-979-8297 (cell) for urgent or emergent issues after hours. You can also call the study coordinator during regular business hours at 617-726-0412 with questions about this research study and for questions about the scheduling of appointments or study visits.

If you want to speak with someone not directly involved in this research study, please contact the Partners Human Research Committee office. You can call them at 857-282-1900.

You can talk to them about:

  • Your rights as a research subject
  • Your concerns about the research
  • A complaint about the research
  • Any pressure to take part in, or to continue in the research study
 

 

Detailed Information

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Why is this research study being done?

NMOSD is a rare autoimmune disease of the central nervous system that primarily attacks the optic nerves and spinal cord leading to blindness and paralysis. Preventive treatment is key to minimizing long term disability. Recently, inebilizumab was approved by the FDA to prevent relapses in NMOSD. The safety profile of inebilizumab a recently published, large international trial showed that infusion related reactions did not occur more than placebo infusions. Although inebilizumab infusions were not provided at home during the trial, the data suggests that home infusions with inebilizumab should be equally safe.

Historically, infusions like inebilizumab that target B cells have been infused at infusion centers. Recently, there has been a trend to provide these infusions at home to make it more comfortable for patients and to decrease cost. Although inebilizumab should be safe to use at home due to its low risk of infusion related reactions, there is no data from patients that suggests NMOSD patients preference to receive the infusions at home. This study will survey NMOSD patients who receive the infusions at home to inquire about their preference for home based infusions versus infusion centers.

Who will take part in this research?

We are asking you to participate in this study because you have neuromyelitis optica spectrum disorder and are using inebilizumab at home as a preventive therapy. We will need a total of 20 patients to complete the study. All participants will be enrolled at MGH and the entire study will be conducted remotely.

This study is being supported by a grant from the manufacturer of inebilizumab, Horizon Therapeutics.

What will happen in this research study?

The design is intended to minimize the number of in-person interactions with between patients and care-givers. All visits with the site will be conducted remotely. If you agree to be in this study, we will ask you to do the following things.

First, we will ask you to sign this consent form before we begin any study visits. All consents will be conducted over a Zoom call. We will also request your clinical records from your doctor in order to track information such as your aquaporin-4 antibody status, previous treatment history and current treatment medications. This information will kept confidential with our team. We will only use your full name and date of birth to coordinate data transfer with the home infusion company involved in this study.

Second, all participants must receive their home infusions through the Boston Home Infusion/Promptcare, which currently provides home infusion services in 31 states. All participants will receive their infusions at home according to their standard protocol. Adverse events and infusion related reactions will be recorded and managed by the home infusion company according to their standard protocol. They will report their notes to us for research purposes. Adverse events are medical problems that arise during or after your infusion, for example, headaches or infusion reactions.

One week following each infusion, you will be surveyed by us for adverse events, patient preferences and quality of life by remote visit with the site study coordinator, which will be conducted at the start, middle (6 months) and end of the study (12 months). Each remote study visit will take approximately 30 minutes.

The study staff will provide you with instructions to use Zoom. Study staff will launch the video conferencing in a private and secure area. To protect your privacy, we ask that you do not take screenshots, photographs, or recordings of any kind with any electronic equipment. A video meeting is similar to us visiting you at home. We may learn more about your home and the people living with you than we would during a visit at the hospital. For example, we may learn information from you that must be reported to public health or public safety authorities. We are required by law to report known or suspected child or elder abuse. If we make such report, the public health and safety authorities can use the information as they see fit and may end up sharing it with other government agencies. Please ask the research staff if you have any questions about this prior to your video visit.

How may we use and share your samples and health information for other research study?

The information we collect in this study may help advance other research. If you join this study, we may remove all information that identifies you (for example, your name, medical record number, and date of birth) and use these de-identified data in other research. It won’t be possible to link the information back to you. Information may be shared with investigators at our hospitals, at other academic institutions or at for-profit, commercial entities. You will not be asked to provide additional informed consent for these uses.

Will you get the results of this research study?

Generally, we will not give you or your doctor information about the results of your individual participation in the research study, though we will share the overall study results with you.

We will also publish what we learn in medical journals.

What are the risks and possible discomforts from being in this research study?

This is an observational study, which means we are observing your clinical care provided according to standard of care. The only part of this study that is outside of standard clinical care is the collection of your safety events, patient preferences and quality of life survey information during telemedicine visit. The risks of participating in a remote study like this one is breach of confidentiality. We will use only software approved by the hospital to conduct these visits, which are designed to minimize this risk. There is also the risk of survey fatigue – even though there are only 3 visits during the 1 year study period.

The Partners standard is to send email securely. This requires you to initially set up and activate an account with a password. You can then use the password to access secure emails sent to you from Partners HealthCare. If you prefer, we can send you "unencrypted" email that is not secure and could result in the unauthorized use or disclosure of your information. If you want to receive communications by unencrypted email despite these risks, Partners HealthCare will not be held responsible. Your preference to receive unencrypted email will apply to emails sent from this research group/study only.

What are the possible benefits from being in this research study?

There are no meaningful benefits to you from taking part in this research study. Others with neuromyelitis optica spectrum disorder may benefit in the future from what we learn in this study.

What other treatments or procedures are available for your condition?

You may receive infusions in any way that meets standard of care, whether at home or at an infusion center or hospital. This study is designed to observe your case if you are receiving your treatment at home.

How may we use and share your samples and health information for other research?

The information we collect in this study may help advance other research. If you join this study, we may remove all information that identifies you (for example, your name, medical record number, and date of birth) and use these de-identified data in other research. It won’t be possible to link the information back to you. Information and/or samples may be shared with investigators at our hospitals, at other academic institutions or at for-profit, commercial entities. You will not be asked to provide additional informed consent for these uses.

Can you still get medical care within Partners if you don’t take part in this research study, or if you stop taking part?

Yes. Your decision won’t change the medical care you get within Partners now or in the future. There will be no penalty, and you won’t lose any benefits you receive now or have a right to receive.

We will tell you if we learn new information that could make you change your mind about taking part in this research study.

What should you do if you want to stop taking part in the study?

If you take part in this research study, and want to drop out, you should tell us. We will make sure that you stop the study safely. We will also talk to you about follow-up care, if needed.

Also, it is possible that we will have to ask you to drop out of the study before you finish it. If this happens, we will tell you why. We will also help arrange other care for you, if needed.

Will you be paid to take part in this research study?

We will not pay you for participation in this study.

We may use your information to develop a new product or medical test to be sold. The Sponsor, hospital, and researchers may benefit if this happens. There are no plans to pay you if your samples or information are used for this purpose.

What will you have to pay for if you take part in this research study?

There are no costs to participate in this study. However, you must have a working smartphone or computer with internet capability to communicate with the study team.

What happens if you are injured as a result of taking part in this research study?

We will offer you the care needed to treat any injury that directly results from taking part in this research study. We reserve the right to bill your insurance company or other third parties, if appropriate, for the care you get for the injury. We will try to have these costs paid for, but you may be responsible for some of them. For example, if the care is billed to your insurer, you will be responsible for payment of any deductibles and co-payments required by your insurer.

Injuries sometimes happen in research even when no one is at fault. There are no plans to pay you or give you other compensation for an injury, should one occur. However, you are not giving up any of your legal rights by signing this form.

If you think you have been injured or have experienced a medical problem as a result of taking part in this research study, tell the person in charge of this study as soon as possible. The researcher's name and phone number are listed in the beginning of this consent form.

If you take part in this research study, how will we protect your privacy?

Federal law requires Partners to protect the privacy of health information and related information that identifies you. We refer to this information as “identifiable information.”

In this study, we may collect identifiable information about you from:

  • Past, present, and future medical records

  • Research procedures, including research office visits, tests, interviews, and questionnaires.

Who may see, use, and share your identifiable information and why they may need to do so:

  • Partners researchers and staff involved in this study

  • The sponsor(s) of the study, and people or groups it hires to help perform this research or

    to audit the research

  • Other researchers and medical centers that are part of this study

  • The Partners ethics board or an ethics board outside Partners that oversees the research

  • A group that oversees the data (study information) and safety of this study

  • Non-research staff within Partners who need identifiable information to do their jobs, such as for treatment, payment (billing), or hospital operations (such as assessing the quality of care or research)

  • People or groups that we hire to do certain work for us, such as data storage companies, accreditors, insurers, and lawyers

  • Federal agencies (such as the U.S. Department of Health and Human Services (DHHS) and agencies within DHHS like the Food and Drug Administration, the National Institutes of Health, and the Office for Human Research Protections), state agencies, and foreign government bodies that oversee, evaluate, and audit research, which may include inspection of your records

  • Public health and safety authorities, if we learn information that could mean harm to you or others (such as to make required reports about communicable diseases or about child or elder abuse.

Some people or groups who get your identifiable information might not have to follow the same privacy rules that we follow and might use or share your identifiable information without your permission in ways that are not described in this form. For example, we understand that the sponsor of this study may use your identifiable information to perform additional research on various products or conditions, to obtain regulatory approval of its products, to propose new products, and to oversee and improve its products’ performance. We share your identifiable information only when we must, and we ask anyone who receives it from us to take measures to protect your privacy. The sponsor has agreed that it will not contact you without your permission and will not use or share your identifiable information for any mailing or marketing list. However, once your identifiable information is shared outside Partners, we cannot control all the ways that others use or share it and cannot promise that it will remain private.

Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop using or sharing your identifiable information. Your permission to use and share your identifiable information does not expire.

The results of this research study may be published in a medical book or journal, or used to teach others. However, your name or other identifiable information will not be used for these purposes without your specific permission.

Your Privacy Rights

You have the right not to sign this form that allows us to use and share your identifiable information for research; however, if you don’t sign it, you can’t take part in this research study.

You have the right to withdraw your permission for us to use or share your identifiable information for this research study. If you want to withdraw your permission, you must notify the person in charge of this research study in writing. Once permission is withdrawn, you cannot continue to take part in the study.

If you withdraw your permission, we will not be able to take back information that has already been used or shared with others, and such information may continue to be used for certain purposes, such as to comply with the law or maintain the reliability of the study.

You have the right to see and get a copy of your identifiable information that is used or shared for treatment or for payment. To ask for this information, please contact the person in charge of this research study. You may only get such information after the research is finished.

This research study has been explained to me, including risks and possible benefits (if any), other possible treatments or procedures, and other important things about the study. I have had the opportunity to ask questions. I understand the information given to me. I give my consent to take part in this research study and agree to allow my health information to be used and shared as described above.

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Signed by Michael Levy
Signed On: August 25, 2021


Signature Certificate
Document name: Preference for Inebilizumab Infused at Home
lock iconUnique Document ID: 5ffaba15cccb0d9b928646e72b321900153ff5ec
Timestamp Audit
August 25, 2021 6:04 pm EDTPreference for Inebilizumab Infused at Home Uploaded by Michael Levy - gromanow@mgh.harvard.edu IP 10.251.226.96