AGNOS is a clinical research study for patients recently diagnosed with relapsing-remitting multiple sclerosis (RRMS). Participants will receive a study treatment for RRMS called ofatumumab. If you qualify and choose to join the study, you will participate for about 18 months. If you agree to participate in the optional 12-month extension study, your participation will last for up to 30 months.
The study drug is given by subcutaneous injections (under the skin) by an autoinjector pen. Participants will receive an injection every 7 days for the first 2 weeks (day 1, 7, and 14) and once monthly starting at month 1 until month 18. The first injection will be done by the study staff. The study staff will show you or a care partner how to do the injections so you can self-inject at home.
Healthy volunteers will also be enrolled in the study so a friend or loved one can participate in this study with you as a study partner. Healthy volunteers will not receive the study drug.
Participants will wear a Study Watch on their wrist throughout the study. The Study Watch will collect digital information such as body movements, heart rate, and other body functions.
If you are enrolled and decide you no longer want to participate in this voluntary study, you can end your participation at any time.
If you qualify and agree to participate in the AGNOS study, you may help doctors and researchers gather important information on the study drug and its effect on young adults recently diagnosed with RRMS.The study will provide an in-depth look into early RRMS and potentially the impact of treatment with ofatumumab in RRMS participants.
Taking part in this research study may not benefit you directly, but researchers may learn new information that could help treat people with RRMS in the future. If you choose to participate in the study, you will receive the study medication and study-related medical care at no cost and may be able to manage your treatment at home.
Healthy volunteers are an important component of the study because they will provide information on normal brain activity as a comparison to RRMS patients receiving study treatment.
Healthy volunteers will provide information that will help researchers determine if beginning ofatumumab early in the course of RRMS will help stabilize the disease long-term. If you are a healthy volunteer, you will not receive any study treatment while in the AGNOS study. Healthy volunteers could potentially contribute valuable information about safety and efficacy outcomes.
Complete this online screener to see if you are eligible to participate in the AGNOS study. If you prequalify, we will refer you to the nearest study site you select. Please note we will collect your information and only share it with the study site if you prequalify for this study based your responses to the online screener.