Phase 3 Multiple Sclerosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older, of any gender
• People who have been diagnosed with relapsing multiple sclerosis (a form of MS where symptoms come and go or worsen in episodes), based on 2017 diagnostic guidelines
• People whose treating neurologist has determined that a type of medication called anti-CD20 therapy is the appropriate next treatment, in line with Dutch prescribing guidelines for relapsing MS
• People who can read and understand written and spoken Dutch or English
• People who are willing and able to give informed consent and follow the study requirements
• People whose MS-related disability score (called EDSS) is 6.5 or below at the screening visit (confirm with trial site)

Who may not be able to join:

• People with a known allergy or intolerance to the study medications (rituximab or ocrelizumab), gadolinium-based MRI contrast dye, or corticosteroids (steroid medicines)
• People diagnosed with primary progressive MS (a form of MS that worsens steadily from the start without relapses)
• People diagnosed with non-active secondary progressive MS (a form of MS that has progressed but without recent relapses or new inflammation)
• People with certain ongoing infectious diseases, including tuberculosis, chickenpox/shingles virus (VZV), hepatitis, or HIV, or those who test positive for hepatitis B surface antigen or hepatitis C at the screening visit
• People with a history of confirmed inflammatory bowel disease such as Crohn's disease or ulcerative colitis
• People with a current or past psychiatric illness, intellectual disability, or cognitive difficulties that would make it hard to give informed consent or follow the study procedures
• People with a heart condition that means treatment with ocrelizumab or rituximab is not medically advisable, according to the official prescribing information
• People with an active cancer, or a past cancer history that means treatment with ocrelizumab or rituximab is not medically advisable, according to the official prescribing information
• People with a low white blood cell count below a specific level, unless it is caused by a current medication and the count returns above the required level before the study begins (confirm with trial site)
• People with a low platelet (blood clotting cell) count below a specific level
• People with elevated liver enzyme levels (ALAT and/or ASAT) more than twice the upper limit of the normal range
• People with a blood creatinine level above a specific level, which may indicate reduced kidney function (confirm with trial site)
• People with elevated bilirubin levels in the blood above the normal range
• People with immunoglobulin G (IgG, a type of immune protein) levels below the lower limit of normal
• People who are pregnant or breastfeeding
• Women who are able to become pregnant and are unwilling or unable to use highly effective contraception throughout the study and for at least three months after the last dose
• People who have previously had a serious or life-threatening reaction during an infusion of ocrelizumab or rituximab
• People who have used corticosteroids or ACTH (a hormone that stimulates steroid production) within one month before starting the study treatment
• People who have previously used certain powerful MS or immune-suppressing treatments, including cladribine, rituximab, alemtuzumab, ocrelizumab, ofatumumab, stem cell therapy, or other long-lasting immune-suppressing therapies (some exceptions may apply — confirm with trial site)
• People currently taking systemic (whole-body) immune-suppressing medications, other than steroids used for MS relapse treatment
• People currently taking part in another clinical drug or device trial, or who finished another such trial less than 30 days ago (people in observational studies only may still be eligible)
• People with a current dependency on alcohol or drugs
• People who have certain metal implants in their body that would make MRI scanning unsafe
• People who are unwilling to undergo MRI scans with gadolinium contrast dye injected through a vein

Important: Always verify eligibility with the trial site directly before applying.