Study on Ofatumumab for Patients with Relapsing Multiple Sclerosis Transitioning from Fumarate-Based Therapies or Fingolimod

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What is this study about?

This clinical trial is focused on studying the effectiveness of a treatment for relapsing multiple sclerosis (RMS), a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The treatment being tested is called Ofatumumab, which is given as an injection under the skin using a pre-filled pen. This study is designed to evaluate how well Ofatumumab works in patients who are transitioning from other RMS treatments, specifically those based on fumarate or a medication called Fingolimod.

The purpose of the study is to assess the effectiveness of Ofatumumab in patients who have experienced breakthrough disease activity, meaning their condition worsened despite being on previous treatments. Participants will receive Ofatumumab every four weeks over a period of 96 weeks. Throughout the study, researchers will monitor the annual relapse rate, which refers to the frequency of new attacks or worsening of symptoms. Additionally, the study will track any side effects, including reactions to the injections, and any changes in laboratory or vital signs results.

The study aims to provide valuable information on the effectiveness and safety of Ofatumumab for individuals with RMS who have not responded adequately to previous treatments. By understanding how this medication works in these patients, researchers hope to improve treatment options for those living with this challenging condition.

1 joining the study

Upon joining the study, the patient must have a diagnosis of relapsing multiple sclerosis (RMS) according to specific criteria. The patient should have a disability status with a score between 0 and 4 on a specific scale.

The patient should have a history of using a maximum of three disease-modifying therapies (DMTs) and must be transitioning from fumarate-based therapies or fingolimod, having used them for at least six months.

2 initial assessment

Before starting the treatment, the patient will undergo an initial assessment to confirm neurological stability within one month prior to the first administration of the study drug.

3 treatment administration

The patient will receive ofatumumab, a medication administered as a 20 mg solution for injection. The injection is given under the skin (subcutaneous use) using a pre-filled pen.

The medication is administered every four weeks throughout the study duration.

4 monitoring and evaluation

The patient’s progress will be monitored over a period of 96 weeks. The primary focus will be on the annual relapse rate, which is based on confirmed relapses.

Secondary evaluations will include monitoring for any adverse events, changes in laboratory or vital signs, and any discontinuation of treatment due to lack of effectiveness or safety concerns.

5 completion of the study

The study is expected to conclude by April 2025. At the end of the study, the effectiveness of the treatment and patient-reported outcomes will be evaluated.

Who Can Join the Study?

  • Must have a diagnosis of MS (Multiple Sclerosis) according to specific criteria from 2017.
  • Must have a type of relapsing MS, which includes relapsing forms and secondary progressive MS.
  • Must have a disability status with a score between 0 to 4 on a scale called the Expanded Disability Status Scale (EDSS).
  • Must have a history of using a maximum of 3 different Disease Modifying Therapies (DMTs), with all types of fumarates counted as one.
  • Must be switching from a therapy based on fumarates, like dimethyl fumarate or diroximel fumarate, or from fingolimod, and must have used it for at least 6 months before starting the study medication.
  • Must have experienced breakthrough disease activity while properly using fumarates or fingolimod for at least 6 months. This means having one or more relapses or signs of activity on an MRI (Magnetic Resonance Imaging) scan, like new or growing lesions.
  • Must be neurologically stable for at least one month before starting the study medication.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of relapsing multiple sclerosis (RMS) cannot participate. RMS is a type of multiple sclerosis where symptoms come and go.
  • Patients who have not experienced breakthrough disease while on fumarates or fingolimod cannot participate. Breakthrough disease means that the disease is still active despite treatment.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are participating in another clinical trial cannot participate.
  • Patients who have a history of certain infections or diseases that could affect the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
University Hospital Bratislava Bratislava Slovakia
UNIVERZITETNI KLINICNI CENTER MARIBOR Maribor Slovenia
Fakultna Nemocnica Trnava Trnava Slovakia
Hospital Beatriz Angelo Loures Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Latvijas Juras medicinas centrs AS Riga Latvia
Ma-Lek Clinical Sp. z o.o. Katowice Poland
Resmedica Sp. z o.o. Kielce Poland
Wromedica I Bielicka A Strzalkowska s.c. Wroclaw Poland
St. Josef-Hospital Bochum Germany
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Hospital Clinico Universitario De Valencia Valencia Spain
Univerzitna nemocnica L. Pasteura Kosice Kosice Slovakia
Hospital Universitario Virgen Macarena Sevilla Spain
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
University Medical Center Ljubljana Ljubljana Slovenia
Neurocentrum Bydgoszcz Sp. z o.o. Bydgoszcz Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Kardiocentrum Nitra s.r.o. Nitra Slovakia
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Heltphib Dm Lr Sxfgu Cdba I Sofj Pbx Barcelona Spain
Mblwqje Ccsqxy Mxlndleder Pxafwc Otz Pleven Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
04.08.2020
Germany Germany
Not recruiting
04.08.2020
Latvia Latvia
Not recruiting
04.08.2020
Poland Poland
Not recruiting
04.08.2020
Portugal Portugal
Not recruiting
04.08.2020
Slovakia Slovakia
Not recruiting
04.08.2020
Slovenia Slovenia
Not recruiting
04.08.2020
Spain Spain
Not recruiting
04.08.2020

Trial locations

Investigated drugs:

Ofatumumab is a medication used in this clinical trial to treat patients with relapsing multiple sclerosis (RMS). It is administered as an injection under the skin every four weeks. The purpose of using ofatumumab in this study is to evaluate its effectiveness in patients who have experienced disease progression despite being treated with other therapies. Ofatumumab works by targeting specific cells in the immune system that are involved in the disease process of multiple sclerosis.

Fumarate-based therapies are a group of medications previously used by patients in this trial before transitioning to ofatumumab. These therapies are designed to help manage relapsing multiple sclerosis by reducing inflammation and the frequency of relapses. They work by modulating the immune system to prevent it from attacking the nervous system.

Fingolimod is another medication that patients in this trial were using before switching to ofatumumab. It is an oral medication that helps control relapsing multiple sclerosis by preventing certain immune cells from reaching the brain and spinal cord, thereby reducing inflammation and the occurrence of relapses.

Investigated diseases:

Relapsing Multiple Sclerosis – Relapsing multiple sclerosis (RMS) is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms, known as relapses. These relapses are followed by periods of partial or complete recovery, called remissions. The disease can cause a wide range of symptoms, including fatigue, vision problems, muscle weakness, and difficulties with coordination and balance. Over time, the frequency and severity of relapses may vary, and some individuals may experience a gradual worsening of symptoms. RMS is one of the most common forms of multiple sclerosis and can significantly impact daily life and activities. The exact cause of RMS is not fully understood, but it involves an abnormal immune response that damages the protective covering of nerve fibers.

Trial ID:
2023-507493-41-00
Protocol code:
COMB157G23101
NCT ID:
NCT04353492
Trial Phase:
Therapeutic confirmatory (Phase III)

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