Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease (NCT04578639) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease
Norway214 participantsStarted 2020-11-02
Plain-language summary
This is a multicenter non-inferiority study, designed to establish non-inferiority of the study treatment rituximab compared with the comparator ocrelizumab for consecutively included patients (male or female) with active relapsing-remitting multiple sclerosis aged 18-60 years.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male and female patients, treatment naïve, and aged between 18 and 60 years included
✓. Women of childbearing potential1 (WOCBP) able and willing to use highly effective methods of birth control2 per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of the study OR until 3 months after last dose administered.
✓. A diagnosis of RRMS according to the 2017 revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018) within the last 12 months.
✓. Disease activity defined as ≥ 1 relapse3 or ≥ 1 new MRI lesion during the last 12 months
✓. EDSS score ≤ 4.0
✓. Absence of comorbidity or drug abuse that preclude study participation
✓. Able to complete treatment or follow-up visits in the study (e.g. no contraindications for MRI or plans of moving)
✓. Able to understand written and spoken Norwegian or English
Exclusion criteria
✕. Known hypersensitivity or other known side effects for any of the study medications, including co-medications such as high glucocorticosteroids
✕. A diagnosis of primary progressive MS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018)
✕. A disease course of secondary progressive MS (Lublin, Reingold et al. 2014)
✕. Any ongoing infection, including tuberculosis, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and/or hepatitis C PCR positivity verified at screening visit.
✕. Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.
✕. Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
✕. Active malignancy or prior history of malignancy except localized basal cell, squamous skin cancer or carcinoma in situ of the cervix.
✕. WBC \< 1.5 x 109/L if not caused by a reversible effect of documented ongoing medication. If WBC \< 1.5 x 109/L is caused by a reversible effect of documented ongoing medication the WBC count must be \> 1,5 x 109/L before start of study treatment.