Impact of ocrelizumab on patient-reported fatigue and quality of life in participants with relapsing multiple sclerosis treated for the first time with ocrelizumab

Phase 4

• Conditions: Multiple sclerosis (MS); Nervous System Diseases; Multiple sclerosis

• Registration Number: ISRCTN55332718
• Lead Sponsor: Roche (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-02
• Last Update Posted: 8 January 2024
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

1. Diagnosis of MS
2. RMS patients, diagnosed by revised McDonald criteria
3. First-time treatment during the course of MS therapy with ocrelizumab according to the local label, regardless of the reason for starting treatment with ocrelizumab (patients may switch to the shorter infusion within the study)

Exclusion Criteria

1. Off-label use of ocrelizumab
2. Participation in interventional studies investigating disease-modifying therapies for MS or in NIS Confidence (ML39632)
3. Severe psychiatric disability
4. Previous treatment with anti-CD20 antibodies
5. Pregnant and/or breastfeeding

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 20/12/2023:<br>Trait fatigue in relapsed multiple sclerosis (RMS) participants treated for the first time with ocrelizumab measured using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months<br><br><br><br>Previous primary outcome measure:<br>Trait fatigue in relapsed multiple sclerosis (RMS) patients treated for the first time with ocrelizumab measured using the FSMC total score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months