Multiple sclerosis (MS) Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Current interventions as of 28/11/2024:
The treatment follows the Summary of Product Characteristics (SmPC). The initial dose of 600 milligrams (mg) ocrelizumab (Ocrevus®) is given as two separate i
a first infusion of 300 mg followed by a second infusion of 300 mg given 2 weeks later. Follow-up doses of ocrelizumab are given as single intravenous infusions of 600 mg every 6 months. The first 600
Sponsors
Roche (Germany)
Roche (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 03/12/2024: 1. Diagnosis of MS 2. RMS participants, 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 (participants may switch to the shorter IV infusion or SC injection within the study) _____ Previous 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 28/11/2024: "Trait fatigue" in 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 _____ Previous primary outcome measure as of 20/12/2023: "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 _____ Previous primary outcome measure: "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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 28/11/2024: 1. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab, measured by the FSMC cognitive score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 2. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab, measured by the FSMC motor score at baseline (i.e., before the first initial dose of ocrelizumab treatment) and over a time period of 24 months 3. “Trait fatigue” in RMS participants treated for the first time with ocrelizumab with a clinically meaningful reduction of =9 points 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 4. Change in “State fatigue” from before to during and after the treatment with ocrelizumab in participants with RMS measured by VAS over a time of 24 months observation period 5. Quality of life assessed using MSIS-29 at baseline and over the 24-month observation period 6. Working productivity and activity assessed using WPAI:MS at baseline and over the 24-month observation period 7. Depression assessed using HADS at baseline and over the 24-month observation period 8. Cognition assessed using PDQ-20 at baseline and over the 24-month observation period 9. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with PROs( MSIS-29, WPAI:MS, HADS, PDQ-20) analyzed using Pearson or Spearman correlation coefficients over the 24-month observation period. 10. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with non-serious adverse events (nsAEs), serious adverse events (SAEs) and adverse events of special interests (AESIs) that occurred during fatigue measurement assessed by PROs over the 24-month observation period 15. Correlation of “trait fatigue” (FSMC total score, cognitive score, motor score) with EDSS over the 24-month observation period | — |
Countries
Germany, Switzerland
Contacts
Public ContactClinical Trials
Outcome results
None listed