Not recruiting

Study Comparing CT-P53 and Ocrelizumab for Patients with Relapsing-Remitting Multiple Sclerosis

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

Verified & featuredResponsive
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Not recruiting

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Multiple Sclerosis (MS), specifically a type called relapsing-remitting multiple sclerosis (RRMS). The study will compare the effects of two treatments: CT-P53 and Ocrevus. Both of these treatments involve a substance called ocrelizumab, which is used to help manage MS. The purpose of the study is to see if CT-P53 works as well as Ocrevus in treating patients with RRMS.

Participants in the study will receive either CT-P53 or Ocrevus through a method called intravenous infusion, which means the medication is given directly into a vein. The study will be conducted over a period of time, and participants will be monitored to see how their bodies respond to the treatment. This includes looking at how the medication moves through the body and its effects on the disease. Some participants may receive a placebo as part of the study.

The study aims to gather information on the safety and effectiveness of CT-P53 compared to Ocrevus. Participants will undergo regular check-ups and tests, such as MRI scans, to track the progress of their condition and any changes in their health. The study will help researchers understand if CT-P53 can be a reliable alternative to Ocrevus for people living with RRMS.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of multiple sclerosis according to specific criteria, recent activity of the condition, and neurological stability.
Step 2
Randomization
Participants are randomly assigned to receive either the investigational drug CT-P53 or the reference drug Ocrevus. This process ensures that the study is unbiased.
Step 3
Treatment initiation
Treatment begins with the administration of the assigned medication. Ocrevus is given as a 300 mg concentrate for solution for infusion, administered intravenously. CT-P53 is also administered as a solution for infusion.
Step 4
Ongoing treatment and monitoring
Participants receive regular doses of their assigned medication. The frequency and duration of these infusions are determined by the study protocol. Monitoring includes regular assessments to track the condition and any side effects.
Step 5
Follow-up assessments
Throughout the study, follow-up assessments are conducted to evaluate the effectiveness of the treatment. This includes measuring the number of new lesions in the brain using MRI scans and other health indicators.
Step 6
Completion of study
The study concludes with a final assessment to gather comprehensive data on the treatment's impact. Participants may be asked to provide feedback on their experience.

Who can join the trial?

5 criteria

The patient must be a male or female aged between 18 and 55 years old, including both ages.
The patient must have been diagnosed with Multiple Sclerosis (MS), which is a condition affecting the brain and spinal cord, following specific guidelines known as the revised McDonald criteria from 2017.
The patient must show signs of recent MS activity, as described in the study details.
The patient must have stable neurological health for at least 30 days. Neurological health refers to the health of the nervous system, which includes the brain and nerves.
The patient must have a score between 0 and 6.0 on the EDSS score, which is a scale used to measure the level of disability in people with MS.

Who cannot join the trial?

10 criteria

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 for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
Patients who are not able to follow the study procedures or attend all required visits cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have any other medical conditions that the study organizers believe would interfere with the study cannot participate.
Patients who are allergic to any of the study medications or their ingredients cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of certain infections or diseases that could affect the study results cannot participate.
Patients who have received certain treatments or medications recently that could interfere with the study cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified & featuredResponsive
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Not recruiting
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
KBC Zagreb
Zagreb, Croatia

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

CT-P53
is an investigational medication being studied for its effectiveness and safety in treating patients with relapsing-remitting multiple sclerosis (RRMS). The trial aims to compare how well CT-P53 works and how it behaves in the body compared to an existing treatment.
Ocrevus
is an approved medication used to treat patients with relapsing-remitting multiple sclerosis (RRMS). In this study, Ocrevus serves as the reference treatment to evaluate the effectiveness and safety of the investigational medication CT-P53. The trial includes both the EU-approved and US-licensed versions of Ocrevus to ensure comprehensive comparison.

What is already known about the treatment

Ocrevus
Ocrevus is administered as an intravenous infusion, typically given in a healthcare setting. It is currently approved and widely used in the treatment of multiple sclerosis, specifically for relapsing-remitting forms. The medication works by targeting and depleting certain immune cells known as B cells, which are involved in the abnormal immune response seen in multiple sclerosis. Ocrevus is classified as a monoclonal antibody, which is a type of biologic drug designed to specifically target and bind to proteins on the surface of B cells, leading to their destruction and reducing inflammation in the nervous system.
CT-P53
CT-P53 is administered through intravenous infusion, similar to Ocrevus, and is currently being studied in clinical trials for its effectiveness in treating relapsing-remitting multiple sclerosis. The drug is designed to be a biosimilar to Ocrevus, meaning it aims to have similar efficacy and safety profiles. Like Ocrevus, CT-P53 targets B cells by binding to specific proteins on their surface, leading to their depletion and helping to manage the immune response associated with multiple sclerosis. It falls under the pharmacological classification of monoclonal antibodies, which are engineered to interact with specific components of the immune system.

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 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 the disease can be unpredictable, with periods of remission and relapses. The most common form is relapsing-remitting multiple sclerosis, where symptoms flare up and then improve for a time.