Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis

NCT07827586 | Recruiting

• 1 other identifier: MN46738
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-naive, switching from intravenous (i.v.) ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c. ocrelizumab.

Conditions

Relapsing-Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12

  At Month 12

Secondary Outcomes (7)

• Proportion of Convenient / Very Convenient Responses on the TASQ Convenience Item Score at Month 12

  At Month 12

• Change From Baseline in Serum Neurofilament Light Chain (NfL) at Months 6 and 12

  Baseline, Months 6 and 12

• Annualized Relapse Rate (ARR) From Baseline to Month 12

  Baseline to Month 12

• Proportion of Relapse-Free Participants From Baseline Through Month 12 Following Ocrelizumab s.c. Initiation

  Baseline to Month 12

• Proportion of Participants Persistent on Treatment From Baseline Through Month 12

  Baseline to Month 12

Study Arms (3)

Cohort 1

Treatment-naive participants initiating ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.

Drug: Ocrelizumab

Cohort 2

Participants who were receiving ocrelizumab i.v. and then switched to ocrelizumab s.c., representing a change in route of administration as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.

Drug: Ocrelizumab

Cohort 3

Treatment experienced participants who were receiving prior DMTs and then switched to ocrelizumab s.c., as outlined in the protocol will be observed for 12 months to characterize participant satisfaction following initiation of ocrelizumab s.c.

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

Ocrelizumab will be administered at the discretion of the physician per local clinical practice and local labeling.

Also known as: Ocrevus

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of participants diagnosed with RRMS who are treated with ocrelizumab s.c. for the first time (initial treatment or treatment switch) as part of their multiple sclerosis (MS) therapy during routine clinical practice

You may qualify if:

• Diagnosis of RRMS according to the revised McDonald criteria (2017 or 2024 revisions).
• Initiation of ocrelizumab s.c in accordance with routine clinical practice and local prescribing information.
• The decision to initiate ocrelizumab s.c. has been made by the treating physician prior to and independently of study participation.
• Willingness to complete the patient-reported outcome questionnaire TASQ, where applicable.

You may not qualify if:

• Participation in any clinical study involving disease modifying therapies for multiple sclerosis during the study period or at the time of enrollment.
• Prior treatment with rituximab.
• Contraindications to ocrelizumab as per the local prescribing information.
• Severe psychiatric or cognitive impairment that, in the opinion of the treating physician, would preclude informed consent, reliable participation in the study, or completion of patient-reported outcomes.
• Any condition which, in the opinion of the treating physician, would interfere with participation in the study or the interpretation of study results.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

University Medical Centre

Ljubljana, 1000, Slovenia

RECRUITING

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: MN46738 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 18, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)