Study on Personalized Ocrelizumab Dosing for Patients with Relapsing Remitting Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying Multiple Sclerosis (MS), specifically the relapsing-remitting type, which 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. The treatment being tested is called Ocrevus, which is a medication given through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. The study is comparing two approaches to using Ocrevus: a personalized dosing method tailored to each patient’s needs and the standard method, which follows a fixed schedule.

The purpose of the study is to determine if the personalized dosing of Ocrevus is as effective as the standard dosing in controlling the activity of Multiple Sclerosis. Participants in the study will receive either the personalized or standard treatment and will be monitored over a period of time to assess the effectiveness of the treatment in preventing relapses and the development of new or enlarging lesions in the brain, which are areas of damage that can be seen on an MRI scan.

Throughout the study, participants will undergo regular check-ups and MRI scans to track their progress. The study aims to provide valuable information on whether adjusting the treatment to each individual’s needs can offer the same benefits as the traditional approach, potentially leading to more tailored and effective care for people with Multiple Sclerosis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria, ensuring the patient is 18 years or older, and has an EDSS score between 0 and 6.5.

The patient must have been treated with ocrelizumab for at least 48 weeks, which includes two 300 mg infusions and one 600 mg infusion. The interval between the last ocrelizumab infusion should not exceed 7.5 months.

2 treatment allocation

The patient is randomly assigned to one of two treatment groups: the personalized B cell tailored ocrelizumab group or the standard ocrelizumab group.

The standard group receives ocrelizumab at a fixed interval of every 24 weeks.

3 treatment administration

Ocrelizumab is administered as an intravenous infusion. The dosage and frequency depend on the assigned treatment group.

The personalized group may receive adjusted dosages based on specific B cell levels, while the standard group receives a fixed dosage.

4 follow-up assessments

Regular follow-up assessments are conducted to monitor the patient’s health and the effectiveness of the treatment.

These assessments include checking for any relapses and conducting MRI scans to detect new or enlarging T2 lesions.

5 end of study evaluation

After 96 weeks, a final evaluation is performed to compare the percentage of relapse-free patients and the presence of new or enlarging T2 MRI lesions between the two treatment groups.

The study aims to demonstrate that the personalized treatment is not inferior to the standard treatment in controlling disease activity.

Who Can Join the Study?

  • You must have a current diagnosis of relapsing-remitting multiple sclerosis. This is a type of multiple sclerosis where symptoms flare up and then improve.
  • You need to be 18 years old or older.
  • Your EDSS score should be between 0 and 6.5. The EDSS score is a way to measure how much multiple sclerosis affects your ability to move and do daily activities.
  • You must have been treated with ocrelizumab for at least 48 weeks. This means you should have received two 300 mg infusions and one 600 mg infusion of the medication.
  • Your last ocrelizumab treatment interval should not have been extended beyond 7.5 months between infusions. This means you should have received your treatments on time without long delays.

Who Cannot Join the Study?

  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to the study medication cannot participate.
  • Patients with other serious health conditions that might interfere with the study cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients who are unable to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Stichting OLVG Amsterdam The Netherlands

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Groene Hart Ziekenhuis Gouda The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Amphia Hospital Breda The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Alrijne Zorggroep Stichting Leiderdorp The Netherlands
Flevoziekenhuis Stichting Almere The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Slingeland Ziekenhuis Doetinchem The Netherlands
Wilhelmina Ziekenhuis Assen Assen The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Rasjjckgt Zdyohmpvlx Sssnkeamk Arnhem The Netherlands
Orrumbfzpm Zfjorpfbqh Gzwojvikb Boxm Scheemda The Netherlands
Shjshwuaehtexfrr Ktqtaszg Byhjgnv Winterswijk The Netherlands
Afupwtmhr Uzy Amsterdam The Netherlands
Eztkmbw Uoaxygfgezwy Mcjeyuj Cedzbbl Rmzuugdks (aiwepcr Mqq Rotterdam The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
16.03.2022

Trial locations

Investigated drugs:

Ocrelizumab: This medication is used to treat relapsing-remitting multiple sclerosis (MS). It works by targeting and reducing the activity of certain immune cells called B cells, which are involved in the abnormal immune response that damages the nervous system in MS. The trial is comparing a personalized approach to administering ocrelizumab, tailored to the patient’s B cell levels, against the standard treatment schedule.

Investigated diseases:

Multiple Sclerosis – Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It occurs when the immune system mistakenly attacks the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, this can cause permanent damage or deterioration of the nerves themselves. The disease often begins with episodes of symptoms that may include fatigue, difficulty walking, numbness, and vision problems. These symptoms can vary widely among individuals and may come and go, with periods of remission and relapse. As the disease progresses, it can lead to more severe physical and cognitive impairments.

Trial ID:
2024-513193-22-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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