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Study Comparing Subcutaneous and Intravenous Ocrelizumab for Patients with Multiple Sclerosis

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Ocrelizumab in patients with Multiple Sclerosis (MS). Multiple Sclerosis is a condition that affects the brain and spinal cord, leading to a range of symptoms such as problems with vision, arm or leg movement, sensation, or balance. The study will compare two forms of administering Ocrelizumab: one is a subcutaneous injection, which means it is injected under the skin, and the other is an intravenous infusion, which means it is given directly into a vein.

The purpose of the study is to investigate how the body processes the subcutaneous form of Ocrelizumab compared to the intravenous form. Participants in the study will receive either the subcutaneous or intravenous form of the medication. The study will monitor various aspects such as the concentration of the medication in the blood, the number of new or enlarging lesions in the brain as seen on an MRI scan, and any side effects that may occur. The study will also look at the presence of antibodies, which are proteins made by the immune system, that might develop in response to the medication.

The study will take place over a period of time, with regular check-ups and assessments to ensure the safety and effectiveness of the treatment. Participants will have their blood tested, undergo MRI scans, and have their vital signs and laboratory test results monitored. The goal is to gather information on how well the subcutaneous form of Ocrelizumab works compared to the intravenous form, and to ensure it is safe for patients with Multiple Sclerosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, diagnosis of multiple sclerosis (MS), and neurological stability.
Participants must have a diagnosis of primary progressive MS (PPMS) or relapsing forms of MS (RMS) and meet other specific health criteria.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health metrics. This includes measuring the expanded disability status scale (EDSS) score and conducting brain magnetic resonance imaging (MRI) scans.
Blood samples may be taken to check for the presence of antidrug antibodies (ADAs) and other biomarkers.
Step 3
Treatment administration
Participants receive the medication Ocrevus, which contains the active substance ocrelizumab.
The medication is administered either subcutaneously (under the skin) or intravenously (into a vein).
The treatment schedule involves regular administration over a specified period, with the first phase lasting from Day 1 to Week 12.
Step 4
Monitoring and follow-up
Participants undergo regular monitoring to assess the effects of the treatment. This includes checking serum levels of ocrelizumab and conducting MRI scans at Weeks 8, 12, and 24.
The study evaluates the number of new or enlarging brain lesions and any adverse events experienced by participants.
Step 5
Final assessment
At the end of the study period, a final assessment is conducted to evaluate the overall impact of the treatment.
This includes a review of changes in vital signs, clinical laboratory test results, and the presence of any antibodies related to the treatment.

Who can join the trial?

6 criteria

Have a diagnosis of either primary progressive **Multiple Sclerosis (MS)** or relapsing forms of MS, based on specific medical guidelines called the revised McDonald 2017 criteria.
Be between the ages of 18 and 65, including both 18 and 65, at the time of signing the consent form to participate in the study.
Have a score between 0 and 6.5 on a scale called the **Expanded Disability Status Scale (EDSS)**, which measures disability in people with MS, at the time of screening.
Have stable neurological health, meaning no significant changes in symptoms, for at least 30 days before both the screening and the start of the study.
If the **disease duration** from the start of MS symptoms is less than 15 years, the EDSS score should be less than 2.0 at screening.
Women who can have children must agree to either not have heterosexual intercourse or use effective birth control during the treatment and for either 6 or 12 months after the last dose of the study medication, depending on local guidelines.

Who cannot join the trial?

712 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection or are currently experiencing an infection.
Patients who have received certain vaccines recently.
Patients who have a history of severe allergic reactions.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have certain heart conditions.
Patients who have certain liver or kidney problems.
Patients who have a history of cancer, except for some types of skin cancer.
Patients who have certain blood disorders.
Patients who have a history of certain autoimmune diseases.
Patients who have had a recent surgery or are planning to have surgery during the study.
Patients who have a history of certain neurological disorders.
Patients who have a history of certain psychiatric disorders.
Patients who have a history of certain lung diseases.
Patients who have a history of certain gastrointestinal diseases.
Patients who have a history of certain metabolic disorders.
Patients who have a history of certain endocrine disorders.
Patients who have a history of certain infectious diseases.
Patients who have a history of certain skin conditions.
Patients who have a history of certain musculoskeletal disorders.
Patients who have a history of certain reproductive disorders.
Patients who have a history of certain genetic disorders.
Patients who have a history of certain eye disorders.
Patients who have a history of certain ear disorders.
Patients who have a history of certain dental disorders.
Patients who have a history of certain immune system disorders.
Patients who have a history of certain blood vessel disorders.
Patients who have a history of certain heart rhythm disorders.
Patients who have a history of certain blood pressure disorders.
Patients who have a history of certain cholesterol disorders.
Patients who have a history of certain blood sugar disorders.
Patients who have a history of certain weight disorders.
Patients who have a history of certain sleep disorders.
Patients who have a history of certain sexual health disorders.
Patients who have a history of certain mental health disorders.
Patients who have a history of certain developmental disorders.
Patients who have a history of certain learning disorders.
Patients who have a history of certain behavioral disorders.
Patients who have a history of certain speech disorders.
Patients who have a history of certain hearing disorders.
Patients who have a history of certain vision disorders.
Patients who have a history of certain taste disorders.
Patients who have a history of certain smell disorders.
Patients who have a history of certain touch disorders.
Patients who have a history of certain balance disorders.
Patients who have a history of certain coordination disorders.
Patients who have a history of certain movement disorders.
Patients who have a history of certain muscle disorders.
Patients who have a history of certain joint disorders.
Patients who have a history of certain bone disorders.
Patients who have a history of certain skin disorders.
Patients who have a history of certain hair disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.
Patients who have a history of certain limb disorders.
Patients who have a history of certain hand disorders.
Patients who have a history of certain foot disorders.
Patients who have a history of certain finger disorders.
Patients who have a history of certain toe disorders.
Patients who have a history of certain nail disorders.
Patients who have a history of certain scalp disorders.
Patients who have a history of certain facial disorders.
Patients who have a history of certain neck disorders.
Patients who have a history of certain chest disorders.
Patients who have a history of certain abdominal disorders.
Patients who have a history of certain pelvic disorders.
Patients who have a history of certain back disorders.

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Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
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EMC Instytut Medyczny S.A.
Poznan, Poland
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Fakultni Nemocnice Hradec Kralove
Novy Hradec Kralove, Czechia

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Investigated drugs

Ocrelizumab (Subcutaneous)
is a medication being studied for its effects on patients with Multiple Sclerosis (MS). In this trial, it is administered under the skin. The study aims to understand how this form of the medication is absorbed and processed by the body, and to compare its effectiveness and safety to the intravenous form.
Ocrelizumab (Intravenous)
is the same medication as the subcutaneous version, but it is given directly into a vein. This trial is comparing the two methods of administration to see if the subcutaneous form works as well as the intravenous form in treating MS. The study also looks at the safety and effects of the medication when given intravenously.

Ocrelizumab

What is already known about the treatment

Ocrelizumab – This medication is administered either as a subcutaneous injection or an intravenous infusion. It is currently being studied in clinical trials to compare the effectiveness and safety of these two methods of administration for treating Multiple Sclerosis (MS). Ocrelizumab is primarily used to manage MS, a condition where the immune system mistakenly attacks the protective covering of nerves. It works by targeting and depleting specific immune cells known as B cells, which are involved in the immune response that damages the nervous system in MS. Ocrelizumab is classified as a monoclonal antibody, a type of medication designed to interact with specific proteins in the body.

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 new symptoms or relapses that can last for days or months. Some people may experience long periods of remission without any new symptoms.