Frequently asked questions​

Here, you will find answers to other questions you may have.

Frequently asked questions​

Here, you will find answers to other questions you may have.
A clinical trial or study is the way we evaluate and compare different study drugs to help patients with various diseases. The study drugs are called “investigational” as they are not approved in this country. The investigational study drugs being studied only enter a clinical study after researchers test them in the laboratory. Clinical studies show if they are well-tolerated and effective and provide information on any side effects. All clinical studies must be reviewed and approved by a regulatory agency to ensure the health, privacy, and safety of study participants. 
The NIMBLE Study is a clinical study that aims to determine whether a combination of two investigational study drugs given as a once monthly subcutaneous injection for adults with generalized myasthenia gravis is effective and well-tolerated. The study drugs being tested are called “investigational” because they have not been approved for use outside of this clinical study. For more information regarding the study, visit the NIMBLE Study page.
To see if you are eligible, take our questionnaire in the Am I eligible? section.
Approximately 235 people worldwide are expected to participate. To find your nearest clinical trial site, please visit our Site Finder.
If you decide to participate and are eligible, you will be in the study for approximately 3.5 years. During this period, you may leave the study at any time without consequences to your usual medical care. Your participation is completely voluntary. If you decide to participate and remain in the study, your responsibility is to follow the study guidelines (e.g., attending the study visits and completing all procedures, informing the study team about any changes to your health, and completing your patient diary daily). These guidelines will be explained to you in detail during the screening process.

Participating in any clinical study involves possible unintended side effects. The known and unknown side effects of participating in this study will be explained to you during the informed consent process, which takes place before you decide to participate. There is no guarantee that you will receive a medical benefit from participating in this study. Your health and safety will be closely monitored throughout this study.

Clinical researchers must follow regulatory guidelines and requirements to help protect the rights, safety, and well-being of clinical study participants. One example of these guidelines is Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing and conducting clinical studies. 

There are, in addition, several entities that provide oversight of clinical studies. These include health authorities or regulators, institutional review boards and independent ethics committees, and data safety and monitoring boards. 

The main reason this study is being conducted is to evaluate an investigational drug for the treatment of generalized myasthenia gravis. Because the drugs in this study are investigational, you may or may not receive any health benefit from taking them. If you choose to participate, you will receive the study drugs at no cost to you. By deciding to participate in this study, you will contribute towards improving our medical knowledge of myasthenia gravis and in the future, this may benefit others diagnosed with myasthenia gravis.
The study is taking place in multiple countries worldwide. To find a clinical study site near you, visit our Site Finder.

Do you have other questions?   ​

If you have additional questions about taking part in this study, you can share this website with your doctor to discuss this clinical research study. Additionally, you can also contact a clinical study site near you.

Site Finder
777 Old Saw Mill River Rd, Tarrytown, NY 10591
For more information, visit www.clinicaltrials.gov or please call +1-844-734-6643.
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