Health TrialsbyHealthPanel

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

ConditionRelapsing-Remitting Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ocrelizumab

    Drug

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

Treatment groups

1,800 Participants
are divided into 3 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 31 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At Month 12

Secondary outcomes

1

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

Time frame
At Month 12
2

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

Time frame
Baseline, Months 6 and 12
3

Annualized Relapse Rate (ARR) From Baseline to Month 12

Time frame
Baseline to Month 12
4

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

Time frame
Baseline to Month 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
Apply now