Study on Monitoring Ocrelizumab Levels for Personalized Treatment in Patients with Relapsing-Remitting and Primary Progressive Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying 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 involves two types of MS: relapsing-remitting and primary progressive. The treatment being tested is a medication called Ocrevus, which is given as an infusion into a vein. The purpose of the study is to explore how the levels of Ocrevus in the blood relate to various health indicators in patients with these types of MS.

Participants in the study will receive Ocrevus and have their blood monitored to measure the concentration of the medication. The study will also look at other health markers, such as the presence of certain proteins and cells in the blood, which are associated with MS. Additionally, the study will assess the participants’ quality of life and clinical status through various tests and questionnaires. Brain scans, such as MRI, will be used to check for changes in the brain, and the progression of disability will be evaluated using a specific scale.

The study aims to determine if the dose of Ocrevus or its concentration in the blood is more closely linked to the health outcomes of patients. It will also examine any side effects related to the medication. The findings could potentially lead to the use of therapeutic drug monitoring in routine clinical practice for patients with MS, helping to tailor treatments more effectively. The study is expected to continue until 2026.

1 initial visit

The patient attends an initial visit where eligibility is confirmed. This includes a diagnosis of relapsing-remitting or primary progressive multiple sclerosis and a negative pregnancy test for women of childbearing age.

The patient signs an informed consent form to participate in the study.

2 treatment administration

The patient receives ocrelizumab through an intravenous infusion. The medication is provided as a 300 mg concentrate for solution.

The frequency and duration of administration are determined by the study protocol and the patient’s specific treatment plan.

3 monitoring and assessments

Regular monitoring of serum concentrations of ocrelizumab and other clinical indicators is conducted.

Assessments include measuring neurofilament light chains, glial fibrillary acidic protein, and antibodies against ocrelizumab.

The patient’s immune system is evaluated by determining the number of CD19+ cells.

4 quality of life and clinical status evaluation

The patient’s quality of life is assessed using the MSQOL-54 questionnaire.

Clinical status is evaluated through tests such as the 25-foot walk test, 9-hole peg test, and symbol digit modalities test.

5 imaging and progression assessment

Brain magnetic resonance imaging is performed to check for new or enlarged lesions.

Disability progression is assessed using the EDSS scale, and the course of multiple sclerosis is evaluated based on the NEDA-3 concept.

6 follow-up and safety monitoring

The occurrence of relapses is monitored for patients with relapsing-remitting multiple sclerosis.

Adverse effects of ocrelizumab are analyzed, including infections and changes in blood count, serum creatinine, and other parameters.

Who Can Join the Study?

Patients must have been diagnosed with relapsing-remitting (RR) or primary progressive (PP) Multiple Sclerosis (MS) and are either already receiving or have just started OCR treatment. OCR treatment refers to a specific medication used for treating MS.
Participants can be men or women who are older than 18 years.
Participants must sign an Informed Consent form, which means they agree to take part in the study after being informed about what it involves.
Female participants who can become pregnant must have a negative result on a serum human chorionic gonadotropin (hCG) test at the start of the study. This test checks for pregnancy. They must also use a highly reliable method of birth control and take a home urine pregnancy test every month during the study.

Who Cannot Join the Study?

Patients who do not have a diagnosis of 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 age range includes adults and older adults.
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?

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Other Sites

Site Name	City	Country	Status
University Hospital Ostrava	Ostrava	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.09.2024

Trial locations

Investigated drugs:

Ocrelizumab

Ocrelizumab is a medication used in the treatment of multiple sclerosis, specifically for relapsing-remitting and primary progressive forms. It works by targeting and reducing certain immune cells that are believed to contribute to the damage of the nervous system in multiple sclerosis. The trial aims to monitor the levels of ocrelizumab in the blood to personalize treatment for better outcomes.

Investigated diseases:

Multiple sclerosis

Multiple Sclerosis – Multiple Sclerosis (MS) is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by the immune system mistakenly 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. MS can manifest in different forms, with relapsing-remitting MS being the most common, where symptoms flare up and then improve. Another form is primary progressive MS, which involves a gradual worsening of symptoms without distinct relapses. Symptoms can vary widely, including fatigue, difficulty walking, numbness, and muscle weakness.

Trial ID:

2024-514549-12-00

Protocol code:

FNO-RS2-OCREPRIPRO

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Monitoring Ocrelizumab Levels for Personalized Treatment in Patients with Relapsing-Remitting and Primary Progressive Multiple Sclerosis

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