An observational study in Multiple Sclerosis, sponsored by Hoffmann-La Roche. Recruiting at 93 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Hoffmann-La Roche · Observational
The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneously (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 842 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 relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), diagnosed according to McDonald criteria of 2017 or revised McDonald criteria 2024, and treated with ocrelizumab SC for the first time during routine clinical practice will be observed in this study.
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:
Participants who are receiving ocrelizumab, SC injection, for the first time as part of their routine MS therapy at physician's discretion in accordance with local clinical practice and/or labeling will be observed for treatment satisfaction with SC injection for up to 12 months.
Drug: Ocrelizumab
Ocrelizumab will be administered as SC injection as per discretion of the treating physician in accordance with local clinical practice and local labeling.
Also known as: RO4964913, Ocrevus
Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC
TASQ-SC is a 12-item, participant-reported questionnaire measuring the impact of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each of the domain/scale scores is scored on a scale of 1-100, where higher scores indicate higher overall satisfaction with the therapy.
Time frame: Month 12
Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After the First Injection and After 6 Months Assessed Using TASQ-SC
TASQ-SC is a 12-item, participant-reported questionnaire measuring the impact of treatment administration on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. Each of the domain/scale scores is scored on a scale of 1-100, where higher scores indicate higher overall satisfaction with the therapy.
Time frame: Baseline, Month 6
Change From Baseline in NfL Protein Levels in Serum
Time frame: Baseline, Month 6, Month 12
Concentration of NfL Protein Levels in Serum
Time frame: Baseline, Month 6, Month 12
Correlation Between NfL Protein Levels in Serum With MS Relapse
The changes in levels of NfL protein levels in serum and its correlation with MS relapse will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS)
The changes in levels of NfL protein levels in serum and its correlation with EDSS will be analyzed using Pearson or Spearman correlation coefficients. EDSS is a scale for assessing neurologic impairment in MS. Values are from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT)
The changes in levels of NfL protein in serum and its correlation with DMT will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine
The changes in levels of NfL protein in serum and its correlation with serum creatinine will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities
The changes in levels of NfL protein in serum and its correlation with co-morbidities will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age
The changes in levels of NfL protein in serum and its correlation with age will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI]
The changes in levels of NfL protein in serum and its correlation with BMI will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count
The changes in levels of NfL protein in serum and its correlation with MRI lesion count will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels
The changes in levels of NfL protein in serum and its correlation with GFAP levels will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Correlation Between NfL Protein Levels in Serum With No Evidence of Disease Activity-3 (NEDA-3)
NEDA-3 is defined by no confirmed MS relapse, no new or enlarging T2 lesions, no Gadolinium-positive T1 lesions, and no six-month confirmed disability worsening. The changes in levels of NfL protein in serum and its correlation with NEDA-3 will be analyzed using Pearson or Spearman correlation coefficients.
Time frame: Up to Month 12
Change From Baseline in Participant Satisfaction With Ocrelizumab SC Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4
TSQM version 1.4 is a 14-item questionnaire used to measure level of satisfaction or dissatisfaction with the medication on 4 domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Each of the domain is scored on likert-type scales of 5 or 7 points ranging from 1 (least satisfied) to 5 or 7 (most satisfied). Item scores are summarized to give four domain scores, which are in turn transformed to a scale of 0-100. Higher scores indicate higher overall satisfaction with the therapy.
Time frame: Baseline, Month 6, Month 12
Number of Participants by Their Level of Satisfaction With Ocrelizumab SC Assessed by Physician Survey
Time frame: Baseline, Month 6, Month 12
Annualized Relapse Rate
Time frame: Month 12
Percentage of Participants With Progression Independent of Relapse Activity (PIRA)
Time frame: Up to Month 12
Number of Participants With Non-serious Adverse Events (nsAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
Time frame: Up to Month 12
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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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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