This clinical trial is focused on studying the long-term safety and effectiveness of a medication called ofatumumab in people with relapsing multiple sclerosis (RMS). Multiple sclerosis is a condition where the immune system mistakenly attacks the protective covering of nerves, leading to communication problems between the brain and the rest of the body. Ofatumumab is a type of medication known as a monoclonal antibody, which is designed to target specific cells in the immune system to help reduce the frequency of relapses in multiple sclerosis.
The purpose of this study is to evaluate how well ofatumumab is tolerated and how safe it is when used over a long period. Participants in the study will receive ofatumumab as an injection under the skin once every four weeks. The study will monitor participants for any side effects or changes in their health, including any changes in their laboratory test results or vital signs. The study will also track the number of relapses participants experience and any changes in their level of disability over time.
Participants will be followed for up to 240 weeks, which is about 4.5 years, to gather comprehensive data on the long-term effects of ofatumumab. The study aims to provide valuable information on the potential benefits and risks of using ofatumumab for managing relapsing multiple sclerosis, helping to inform future treatment options for this condition.
1joining the study
Upon joining the study, the participant will begin receiving the medication ofatumumab.
The medication is administered as a subcutaneous injection every four weeks.
2medication administration
The participant will receive ofatumumab at a dose of 20 mg.
This will continue every four weeks throughout the study duration.
3monitoring and assessments
Regular monitoring will occur to assess safety and tolerability.
This includes checking for any adverse events and monitoring laboratory results and vital signs.
4long-term evaluation
The study aims to evaluate the long-term safety and effectiveness of ofatumumab.
Participants will be monitored for up to 240 weeks, which is approximately 4.5 years.
5end of study
The study is expected to conclude in September 2028.
Final assessments will be conducted to evaluate the overall outcomes of the treatment.
Who Can Join the Study?
The patient must have relapsing multiple sclerosis (RMS), which is a type of multiple sclerosis where symptoms come and go.
The patient must have participated in a previous study by Novartis that involved taking a medication called ofatumumab at a dose of 20 mg under the skin every 4 weeks.
The patient must have been an adult, meaning they were 18 years or older, during the previous study on RMS.
The patient must have completed the previous study while still taking the study medication.
The patient must provide written informed consent, which means they agree to participate in the study after being fully informed about it.
Both male and female patients are eligible to participate.
Who Cannot Join the Study?
Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have received any other treatment for multiple sclerosis within the last month.
Patients who have a history of allergic reactions to similar medications.
Patients who have participated in another clinical trial within the last month.
Patients who have a history of drug or alcohol abuse.
Patients who have any condition that affects their immune system.
Patients who have been diagnosed with cancer in the past five years.
Patients who have any condition that affects their ability to understand or follow study instructions.
Ofatumumab is a medication used in this clinical trial to treat individuals with relapsing multiple sclerosis (RMS). It is administered as an injection under the skin once every four weeks. The purpose of this study is to assess the long-term safety, tolerability, and effectiveness of ofatumumab for patients with RMS.
Relapsing Multiple Sclerosis (RMS) – Relapsing multiple sclerosis is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms. These episodes, known as relapses, are followed by periods of partial or complete recovery. The disease can lead to symptoms such as fatigue, difficulty walking, numbness, and vision problems. Over time, the frequency and severity of relapses may vary, and some individuals may experience a gradual worsening of symptoms. The exact cause of RMS is not fully understood, but it involves an immune system attack on the protective covering of nerves. This damage disrupts communication between the brain and the rest of the body.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Austria 
Belgium 
Bulgaria 
Croatia 
Czechia 
Denmark 
Estonia 
Finland 
France 
Germany 
Greece 
Hungary 
Latvia 
Lithuania 
Norway 
Poland 
Portugal 
Slovakia 
Spain 
Sweden 
The Netherlands 