RecruitingOBSERVATIONAL

A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis

This study is for people in Germany with Relapsing Multiple Sclerosis (RMS) who are starting certain approved injectable or oral treatments. It's an "observational" study, meaning researchers will simply watch and collect information about how these medicines work in a real-world setting, rather than testing new drugs. For up to four years, they'll gather details like how often relapses occur, how the disease changes, and general health information. The aim is to understand the effectiveness of medicines like ofatumumab, glatiramer acetate, interferon β1, teriflunomide, dimethyl fumarate (DMF), and diroximel fumarate (DRF) when used in everyday treatment.

At a glance

Status

Recruiting

Sponsor

Novartis Pharmaceuticals

Enrolment target

800

Start

10 May 2022

Estimated completion

30 May 2029

Relapsing Multiple Sclerosis

What is this study about?

This study aims to understand how existing, approved medications for Relapsing Multiple Sclerosis (RMS) work in real-life situations. RMS is a type of MS where symptoms come and go. Researchers in Germany want to observe patients who are already starting treatment with specific injectable or oral medications, rather than testing new ones. This type of study, called an "observational" or "non-interventional" study, means that the doctor and patient have already decided on the best treatment before the patient considers joining the study.

The main goal is to collect information over time about how people with RMS respond to their chosen treatment. This includes looking at things like how many relapses they have, changes in their symptoms, and general health status. By gathering this real-world data from many patients, doctors can learn more about the usual effects of these treatments in a wider group of people.

Researchers will collect details such as the patient's medical history, how long they've had MS, lab results, and MRI scan information. The study can last up to four years, and this information helps us get a clearer picture of how these important MS medicines work for patients in their daily lives.

Key takeaways

Observational study looking at existing MS treatments.
For adults (18+) with Relapsing Multiple Sclerosis (RMS).
You must be starting one of the specific approved MS medications.
No new treatments are given; your routine care remains the same.
Participation can last up to four years.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be an adult (18 years or older) with Relapsing Multiple Sclerosis (RMS). Your MS diagnosis would have been made using specific medical guidelines (called the McDonald criteria). You must also have active MS, meaning you've had a certain number of relapses in the past one to two years.

Your doctor must have already decided that you will start or have recently started (within the last 14 days) one of the specific approved injectable or oral MS treatments being looked at in this study. Depending on the group you might join, there are also some specific rules about whether you've used certain MS medicines before.

There are also reasons why you might not be able to join. For example, if you've been living with MS symptoms for more than five years, or if you've already had many different MS treatments before. The study is also not for people whose MS treatment is different from what is normally approved for their condition.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Relapsing Multiple Sclerosis (RMS) with recent active disease?
Are you about to start, or have you recently started (within 14 days), one of the specific approved injectable or oral MS treatments?
Have you had MS symptoms for less than five years?
Are you not currently receiving treatment that is outside of the normal approved usage?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be observed for up to two years, with a chance to extend this for another two years, making a total of up to four years. During this time, the study team will collect information about your health through questionnaires and electronic forms. They will also look at your medical records, including details about your MS, lab tests, MRI scans, and any relapses you experience.

The important thing to know is that the study won't change your medical care. All your check-ups, assessments, and treatments will be exactly what your doctor already planned for your routine MS care. This means you won't have extra tests or visits specifically for the study that aren't part of your usual treatment plan. These visits can happen in person or sometimes even through telemedicine (like a video call) if your doctor decides that's appropriate for your care.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of how current MS treatments work in a real-world setting, which can help other patients in the future. You will not receive any new or experimental treatments, as this study observes existing ones. As this is an observational study that doesn't change your medical care, there are generally no additional risks beyond those associated with your routine medical treatment. You are free to withdraw from the study at any time without giving a reason, and this will not affect the quality of your medical care.

Locations (129)

Novartis Investigative Site
Verified postcode
Albstadt, Germany· Recruiting
Novartis Investigative Site
Verified postcode
Hettingen, Germany· Completed
Novartis Investigative Site
Verified postcode
Hettingen, Germany· Recruiting
Novartis Investigative Site
Verified postcode
Mannheim, Germany· Recruiting
Novartis Investigative Site
Verified postcode
Nagold, Germany· Recruiting
Novartis Investigative Site
Verified postcode
Schwäbisch Hall, Germany· Recruiting
Novartis Investigative Site
Verified postcode
Schwetzingen, Germany· Recruiting
Novartis Investigative Site
Verified postcode
Bamberg, Germany· Active not recruiting
Novartis Investigative Site
Verified postcode
Dillingen an der Donau, Germany· Active not recruiting
Novartis Investigative Site
Verified postcode
Munich, Germany· Withdrawn
Novartis Investigative Site
Verified postcode
Munich, Germany· Withdrawn
Novartis Investigative Site
City only
Neuburg A.d. Donau, Germany· Active not recruiting

Common questions

What kind of treatments are being looked at?

The study is looking at several approved treatments for MS, including medicines like ofatumumab, glatiramer acetate, interferon β1, teriflunomide, dimethyl fumarate (DMF), and diroximel fumarate (DRF).

Do I have to take a new medicine if I join?

No, you don't. This study is for people who are already starting an approved MS treatment as part of their regular care. You won't be given any new or experimental medicines by the study.

How long will I be in the study?

You could be in the study for up to two years, with an option to continue for another two years, making a total of up to four years.

Will my care change if I join this study?

No, your medical care will remain exactly as your doctor plans it. The study simply collects information about your standard treatment and health.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without affecting your medical treatment or relationship with your doctor.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com +41613241111 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.