An observational study in Multiple Sclerosis, sponsored by Hoffmann-La Roche. Completed at 158 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Hoffmann-La Roche · Observational
This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 1,710 is above the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with RMS or PPMS undergoing routine clinical care
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.
Drug: Ocrelizumab
Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.
Also known as: Ocrevus
Changes in the overall SymptoMScreen score in participants with RMS
SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities)
Time frame: 4 years
Changes in the overall SymptoMScreen score in participants with PPMS
SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities)
Time frame: 4 years
Percentage of RMS Participants with Adverse Events
Time frame: 4 years
Percentage of PPMS participants with Adverse Events
Time frame: 4 years
Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS
Time frame: 4 years
Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS
Time frame: 4 years
Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants
Time frame: 4 years
Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants
Time frame: 4 years
Change in the score of ABILHAND - 56 scale in RMS participants
Time frame: 4 years
Change in the score of ABILHAND - 56 scale in PPMS participants
Time frame: 4 years
Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant
Time frame: 4 years
Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants
Time frame: 4 years
Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants
Time frame: 4 years
Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants
Time frame: 4 years
Change in the score of MSWS - 12 scale in RMS participants
Time frame: 4 years
Change in the score of MSWS - 12 scale in PPMS participants
Time frame: 4 years
Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in RMS Participants
Time frame: 4 years
Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in PPMS Participants
Time frame: 4 years
Frequency of relapses over time in RMS patients
Time frame: 4 years
Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time
Time frame: 4 years
Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time
Time frame: 4 years
Showing the first 100 of 158 sites across 25 countries. Choose a country and city above to see the rest.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
No publications or documents are linked to this record.
Ran from Nov 2018 to primary completion in Jan 2026, 86 months.
Of 91 industry-sponsored observational studies under Multiple Sclerosis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 81. This study's 86 months is above that.
Counting every sponsor, half of 425 studies reached it within 41 months; a quarter within 15 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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