ocrelizumab for Multiple sclerosis

Inclusion criteria

• {"criterion_text":"-A diagnosis of RRMS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018) within the last 12 months."}
• {"criterion_text":"-REDUCE: Stable disease, defined as no relapse3 or new MRI lesion4 during the last 24 months before enrollment"}
• {"criterion_text":"-REDUCE: Women of childbearing potential1 (WOCBP) able and willing to use highly effective methods of birth control2 that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration ofmonths after last dose administered to comply with CTFG Contraception guidance Version 1.1 (CTFG 21/09/2020)."}
• {"criterion_text":"-REDUCE: Absence of comorbidity or drug abuse that preclude study participation"}
• {"criterion_text":"-REDUCE: Able to complete treatment or follow-up visits in the study (e.g. no contraindications for MRI or plans of moving)"}
• {"criterion_text":"-REDUCE: . Able to understand written and spoken Norwegian or Swedish"}
• {"criterion_text":"-REDUCE: Capable of giving signed informed consent as described in Appendix 1.2 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol"}
• {"criterion_text":"-Treatment naïve patients aged between 18 and 60 years included"}
• {"criterion_text":"-Disease activity defined as ≥ 1 relapse1 or ≥ 1 new MRI lesion2 during the last 12 months"}
• {"criterion_text":"-EDSS score ≤ 4.0"}
• {"criterion_text":"-Absence of comorbidity that preclude study participation"}
• {"criterion_text":"-Written informed consent for study participation"}
• {"criterion_text":"-Able to understand written and spoken Norwegian or Swedish"}
• {"criterion_text":"-Able to complete treatment or follow-ups in the study (e.g. no contraindications for MRI, plans of moving)"}
• {"criterion_text":"-REDUCE: Previously enrolled in and completed the OVERLORD-MS trial and OVERLORD-SWITCH study"}

Exclusion criteria

• {"criterion_text":"-A diagnosis of progressive MS according to the revised diagnostic criteria of McDonald (Thompson, Banwell et al. 2018)"}
• {"criterion_text":"-Previous MS therapy"}
• {"criterion_text":"-Comorbidity that is not compatible with B cell depletion therapy"}
• {"criterion_text":"-Blood screening results (i.e. hematology, chemistry, infection) that is not compatible with B cell depletion therapy"}
• {"criterion_text":"-Comorbidity that otherwise preclude study participation"}
• {"criterion_text":"-Pregnancy or lactating female patients"}
• {"criterion_text":"-REDUCE: Any disease that is a contraindication to treatment with rituximab (as described in the SMPC)"}
• {"criterion_text":"-REDUCE: Not longer treated with rituximab (e.g. switched to another treatment for MS or stopped MStreatme"}

Primary endpoints

• {"endpoint_text":"-Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 6 (re-baseline) to month 24","definition_or_measurement_approach":"Measured by brain MRI (T2-weighted) assessing presence of new or enlarging lesions between month 6 (re-baseline) and month 24."}
• {"endpoint_text":"-SWITCH: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 24 to month 36","definition_or_measurement_approach":"Measured by brain MRI (T2-weighted) assessing presence of new or enlarging lesions between month 24 and month 36."}
• {"endpoint_text":"-REDUCE: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 36 to month 60 compared to the period before (month 0-36","definition_or_measurement_approach":"Measured by brain MRI (T2-weighted) assessing new or enlarging lesions from month 36 to month 60 compared with period month 0-36."}

Secondary endpoints

• {"endpoint_text":"-The annual relapse rate from baseline to month 24","definition_or_measurement_approach":"Annualized relapse rate calculated from baseline to month 24 as recorded in clinical assessments."}
• {"endpoint_text":"-Proportion of patients without relapses from baseline to month 24","definition_or_measurement_approach":"Proportion of participants with no clinical relapses recorded between baseline and month 24."}
• {"endpoint_text":"-Proportion of patients with progression in SDMT from baseline to month 24. Progression in SDMT is defined as patients experiencing a reduction of 15% or more from baseline (Strober, DeLuca et al. 2019, Marstrand, Osterberg et al. 2020)","definition_or_measurement_approach":"Measured by Symbol Digit Modalities Test (SDMT); progression defined as ≥15% reduction from baseline to month 24."}
• {"endpoint_text":"-Frequency of SAE/SAR and AESI during 24 months of treatment","definition_or_measurement_approach":"Safety events recorded over 24 months: Serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI)."}
• {"endpoint_text":"-The frequency of immediate and delayed infusion reactions during 24 months of treatment","definition_or_measurement_approach":"Recorded infusion reactions (immediate and delayed) during 24 months of treatment per clinical reporting."}
• {"endpoint_text":"-The frequency of infections during 24 months of treatment","definition_or_measurement_approach":"Infections recorded as adverse events over 24 months."}
• {"endpoint_text":"-The frequency any malignancies during 24 months of treatment","definition_or_measurement_approach":"Malignancies recorded as adverse events over 24 months."}
• {"endpoint_text":"-Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from baseline to month 6, and from baseline to month 24","definition_or_measurement_approach":"Measured by brain MRI (T2-weighted) assessing new/enlarging lesions from baseline to month 6 and baseline to month 24."}
• {"endpoint_text":"-Proportion of patients without new gadolinium enhancing T1-weighted brain MRI lesions at month 6, month 12 and month 24","definition_or_measurement_approach":"Measured by T1-weighted MRI with gadolinium enhancement at specified timepoints."}
• {"endpoint_text":"-Change in brain volumes from baseline to month 24 and from month 6 to month 24","definition_or_measurement_approach":"MRI volumetric measures comparing baseline to month 24 and month 6 to month 24."}
• {"endpoint_text":"-SWITCH: The annual relapse rate from month 30 to month 36","definition_or_measurement_approach":"Annualized relapse rate calculated for month 30 to month 36 interval."}
• {"endpoint_text":"-SWITCH: Proportion of patients without relapses from month 30 to month 36","definition_or_measurement_approach":"Proportion with no relapses recorded between month 30 and month 36."}
• {"endpoint_text":"-SWITCH: Proportion of patients without new gadolinium enhancing T1-weighted brain MRI lesions from month 24 to month 36","definition_or_measurement_approach":"T1-weighted gadolinium MRI evaluation for new lesions between month 24 and month 36."}
• {"endpoint_text":"-SWITCH: Change in brain volumes from month 24 to month 36","definition_or_measurement_approach":"MRI volumetric change measured between month 24 and month 36."}
• {"endpoint_text":"-SWITCH: Proportion of patients with 6-months confirmed disability progression (6M-CDP) as measured by the Expanded disability status scale (EDSS) from month 30 to month 36","definition_or_measurement_approach":"6-month confirmed disability progression assessed by EDSS between month 30 and month 36 (definition referenced in protocol section 8.2.3)."}
• {"endpoint_text":"-SWITCH: Proportion of patients with 6-months confirmed disability improvement (6M-CDI) as measured by the Expanded disability status scale (EDSS) from month 30 to month 36","definition_or_measurement_approach":"6-month confirmed disability improvement assessed by EDSS between month 30 and month 36."}
• {"endpoint_text":"-SWITCH: Proportion of patients with 6M-CDP in SDMT from month 30 to month 36","definition_or_measurement_approach":"6-month confirmed progression in SDMT assessed between month 30 and month 36."}
• {"endpoint_text":"-SWITCH: Frequency of SAE/SAR and AESI from month 30 to month 36","definition_or_measurement_approach":"Safety events recorded in SWITCH interval month 30-36."}
• {"endpoint_text":"-SWITCH: The frequency of immediate and delayed infusion reactions from month 30 to month 36","definition_or_measurement_approach":"Infusion reactions recorded during month 30-36 interval."}
• {"endpoint_text":"-SWITCH: The frequency of infections from month 30 to month 36","definition_or_measurement_approach":"Infections recorded during month 30-36 interval."}
• {"endpoint_text":"-SWITCH: The frequency any malignancies from month 30 to month 36","definition_or_measurement_approach":"Malignancies recorded during month 30-36 interval."}
• {"endpoint_text":"-REDUCE: The annual relapse rate from month 36 to month 60","definition_or_measurement_approach":"Annualized relapse rate calculated from month 36 to month 60."}
• {"endpoint_text":"-REDUCE: Proportion of patients without relapses from month 36 to month 60","definition_or_measurement_approach":"Proportion with no relapses between month 36 and month 60."}
• {"endpoint_text":"-REDUCE: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 36 to month 60","definition_or_measurement_approach":"T2-weighted MRI assessment of new/enlarging lesions between month 36 and month 60."}
• {"endpoint_text":"-REDUCE: Change in brain volumes from month 36 to month 60","definition_or_measurement_approach":"MRI volumetric change measured month 36 to month 60."}
• {"endpoint_text":"-REDUCE: Proportion of patients with 6-months confirmed disability progression (6M-CDP) as measured by the Expanded disability status scale (EDSS) (Kurtzke 1983) from month 36 to month 60","definition_or_measurement_approach":"6M-CDP by EDSS measured between month 36 and month 60."}
• {"endpoint_text":"-REDUCE: Proportion of patients with 6-months confirmed disability improvement (6M-CDI) as measured by the Expanded disability status scale (EDSS) (Kurtzke 1983) from month 36 to month 60","definition_or_measurement_approach":"6M-CDI by EDSS measured between month 36 and month 60."}
• {"endpoint_text":"-REDUCE: Proportion of patients with 6M-CDP in SDMT from month 36 to month 60","definition_or_measurement_approach":"6-month confirmed progression in SDMT measured between month 36 and month 60."}
• {"endpoint_text":"-REDUCE: Frequency of SAE/SAR and AESI from month 36 to month 60","definition_or_measurement_approach":"Safety events recorded during month 36-60."}
• {"endpoint_text":"-REDUCE: The frequency of grade 2 or above immediate and delayed infusion reactions from month 36 to month 60","definition_or_measurement_approach":"Grade ≥2 infusion reactions recorded between month 36 and month 60."}
• {"endpoint_text":"-REDUCE: The frequency of grade 2 or above infections from month 36 to month 60","definition_or_measurement_approach":"Grade ≥2 infections recorded between month 36 and month 60."}
• {"endpoint_text":"-REDUCE: The frequency any malignancies from month 36 to month 60","definition_or_measurement_approach":"Malignancies recorded between month 36 and month 60."}
• {"endpoint_text":"-Proportion of patients with 6-months confirmed disability progression (6M-CDP) as measured by the Expanded disability status scale (EDSS) (Kurtzke 1983) from baseline to month 24.EDSS at month 24 is confirmed at month 30 (6M-CDP is defined in section 8.2.3).","definition_or_measurement_approach":"6M-CDP assessed by EDSS from baseline to month 24 with confirmation at month 30 per protocol definition."}
• {"endpoint_text":"-Proportion of patients with 6-months confirmed disability improvement (6M-CDI) as measured by the Expanded disability status scale (EDSS) (Kurtzke 1983) from baseline to month 24. EDSS at month 24 is confirmed at month 30 (6M-CDI is defined in section 8.2.3)","definition_or_measurement_approach":"6M-CDI assessed by EDSS from baseline to month 24 with confirmation at month 30 per protocol definition."}
• {"endpoint_text":"-SWITCH: Proportion of patients with no new or enlarging T2-weighted brain MRI lesions from month 24 to month 36","definition_or_measurement_approach":"T2-weighted MRI assessment of new/enlarging lesions between month 24 and month 36 (SWITCH)."}

Norway

Latest Decision Or Authorization Date

25-02-2026

Processing Time Days

29

Number Of Sites

12

Number Of Participants

206

Sweden

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

30

Number Of Sites

1

Number Of Participants

8

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway