Study Comparing Rituximab and Ocrelizumab for Patients with Active Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying the treatment of Multiple Sclerosis (MS), a disease that affects the brain and spinal cord, leading to a range of symptoms such as fatigue, difficulty walking, and vision problems. The study is comparing two treatments: Rituximab and Ocrelizumab. Both of these are medications given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein. Rituximab is being used in this study as a biosimilar, which is a type of medication that is very similar to an already approved drug, but it is not yet approved specifically for treating MS.

The purpose of the study is to determine if Rituximab is as effective as Ocrelizumab in treating active forms of MS. Participants in the study will receive treatment over a period of 24 months, with the option to continue for an additional 36 months. During the first 24 months, the study will focus on whether patients have no new or enlarging T2 white matter lesions, which are areas of damage in the brain that can be seen on an MRI scan. After the initial 24 months, the study will explore the long-term effects and safety of both treatments, as well as whether extending the time between doses might be beneficial for patients who have been stable on these therapies.

Throughout the study, participants will be monitored for any changes in their condition, including the presence of new symptoms or worsening of existing ones. The study aims to provide valuable information on the effectiveness and safety of these treatments for people living with MS, potentially offering new insights into managing the disease over the long term.

1 initial treatment phase

The study begins with the administration of either ocrelizumab or rituximab. These medications are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

The specific products used are Ocrevus 300 mg and Rixathon 500 mg or Ruxience 500 mg. The infusion is performed in a controlled setting to monitor any immediate reactions.

2 core study period

The core study lasts for 24 months. During this time, the effectiveness of the treatment is evaluated by checking for the absence of new or enlarging T2 white matter lesions in the brain.

Regular assessments are conducted to monitor the progression of multiple sclerosis and any side effects of the treatment.

3 extension study phase

After completing the initial 24 months, there is an option to continue in an extension study for an additional 36 months.

This phase examines the long-term effects and safety of the treatments, as well as the potential benefits of extended interval dosing, which involves receiving the medication less frequently if the disease remains stable.

4 monitoring and evaluation

Throughout the study, regular monitoring is conducted to assess the patient’s condition. This includes checking for any new symptoms or changes in the disease.

The primary goal is to ensure that there are no new or enlarging lesions and to evaluate the overall health and response to the treatment.

Who Can Join the Study?

Must be between 18 and 65 years old.
Must have a diagnosis of multiple sclerosis (MS) according to the 2017 McDonald criteria. This is a set of guidelines used to diagnose MS.
Must have an Expanded Disability Status Scale (EDSS) score of 6.5 or less. This scale measures the level of disability in people with MS.
Must meet criteria for active MS, which can include:
- For those who have never been treated or haven’t had treatment in the last 3 months:
  - At least 2 relapses in the past 12 months, or
  - At least 1 relapse in the past 12 months and at least 9 T2 lesions on a brain or spinal MRI, and at least 1 contrast-enhancing lesion or new/enlarging T2 lesion on MRI in the past 12 months.
- For those who have been treated before:
  - At least 1 relapse in the past 12 months, or
  - At least 1 contrast-enhancing lesion or 2 new/enlarging T2 lesions on a brain MRI in the past 12 months.
- For those with progressive MS:
  - At least 1 relapse in the past 12 months, or
  - At least 1 contrast-enhancing lesion in the past 12 months, or
  - At least 1 new/enlarging T2 lesion on a brain MRI in the past 12 months, or
  - At least 2 new/enlarging T2 lesions on a brain MRI in the past 24 months, or
  - Increased levels of neurofilament light chain in blood or spinal fluid in the past 12 months. This is a protein that can indicate nerve damage.
Must sign a written informed consent, which means agreeing to participate in the study after understanding all the details.
For the long-term follow-up phase:
- Must have completed the first 24 months of the study.
- Must have no signs of active disease in the past 18 months.
- Must sign a written informed consent.
For extended interval dosing outside the randomization process:
- Must have completed the first 24 months of the study.
- Must be recommended by a physician to switch to extended interval dosing due to low IgG levels (less than 6.1 g/L) or frequent infections. IgG is a type of antibody important for fighting infections.
- Must have no signs of active disease in the past 18 months.
- Must sign a written informed consent.

Who Cannot Join the Study?

Patients who do not have multiple sclerosis cannot participate. Multiple sclerosis is a condition that affects the brain and spinal cord.
Patients who are not within the specified age range cannot participate. The study includes certain age groups only.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
Regionshospitalet Viborg	Viborg	Denmark
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Sygehus Soenderjylland Soenderborg	Aabenraa	Denmark
Department of Pediatric and Adolescent Medicine, Kolding Hospital	Kolding	Denmark
Ntzcdzjqctuft Hukvpsuw Hyterlae	København S	Denmark
Hpbfjv Hkkbnrli	Herlev	Denmark
Abjdwh Uidvvwyhbk Hqunmwme	Aarhus	Denmark
Runvel Mlhtarprven	Herning	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	28.04.2021

Trial locations

Investigated drugs:

Ocrelizumab is a medication used in the treatment of multiple sclerosis (MS). It works by targeting and depleting certain immune cells called CD20-positive B cells, which are believed to play a role in the abnormal immune response that damages the nervous system in MS. The study aims to compare the effectiveness of ocrelizumab with another medication in managing active forms of MS.

Rituximab is another medication used in the treatment of multiple sclerosis. Similar to ocrelizumab, it targets CD20-positive B cells to help reduce the immune system’s attack on the nervous system. The study is designed to determine if rituximab is as effective as ocrelizumab in treating active MS, with a focus on the long-term safety and efficacy of both medications.

Investigated diseases:

Multiple sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system attacking the protective sheath (myelin) that covers nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, the disease can cause permanent damage or deterioration of the nerves themselves. Symptoms vary widely and can include fatigue, difficulty walking, numbness or tingling, muscle weakness, and problems with coordination and balance. The progression of multiple sclerosis can be unpredictable, with periods of remission and relapse. The disease can manifest in different forms, such as relapsing-remitting, primary progressive, or secondary progressive multiple sclerosis.

Trial ID:

2024-514287-84-00

Protocol code:

DanNORMS

NCT ID:

NCT04688788

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Rituximab and Ocrelizumab for Patients with Active Multiple Sclerosis

What is this study about?

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