Multiple Sclerosis
Conditions
Brief summary
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).
Interventions
DRUGOcrelizumab
Ocrelizumab will be administered as SC injection as per discretion of the treating physician in accordance with local clinical practice and local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of MS * RMS and PPMS participants diagnosed according to the McDonald criteria of 2017 or revised McDonald criteria 2024 * First treatment during the course of MS therapy with ocrelizumab SC according to the local prescribing information, regardless of the reason for starting treatment with ocrelizumab
Exclusion criteria
* Participation in interventional studies investigating DMTs for MS * Prior or simultaneous participation in CONFIDENCE or MoOzaRt (ISRCTN55332718) non interventional study (NIS) at the same study site * Prior treatment with rituximab (MabThera®) or ublituximab (Briumvi®) * Severe psychiatric disability * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC | Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Participant Satisfaction With Ocrelizumab SC Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4 | Baseline, Month 6, Month 12 | 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. |
| Number of Participants by Their Level of Satisfaction With Ocrelizumab SC Assessed by Physician Survey | Baseline, Month 6, Month 12 | — |
| Annualized Relapse Rate | Month 12 | — |
| Percentage of Participants With Progression Independent of Relapse Activity (PIRA) | Up to Month 12 | — |
| Number of Participants With Non-serious Adverse Events (nsAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs) | Up to 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 | Baseline, Month 6 | 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. |
| Change From Baseline in NfL Protein Levels in Serum | Baseline, Month 6, Month 12 | — |
| Concentration of NfL Protein Levels in Serum | Baseline, Month 6, Month 12 | — |
| Correlation Between NfL Protein Levels in Serum With MS Relapse | Up to Month 12 | 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. |
| Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS) | Up to Month 12 | 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. |
| Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT) | Up to Month 12 | The changes in levels of NfL protein in serum and its correlation with DMT will be analyzed using Pearson or Spearman correlation coefficients. |
| Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine | Up to Month 12 | The changes in levels of NfL protein in serum and its correlation with serum creatinine will be analyzed using Pearson or Spearman correlation coefficients. |
| Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities | Up to Month 12 | The changes in levels of NfL protein in serum and its correlation with co-morbidities will be analyzed using Pearson or Spearman correlation coefficients. |
| Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age | Up to Month 12 | The changes in levels of NfL protein in serum and its correlation with age will be analyzed using Pearson or Spearman correlation coefficients. |
| Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI] | Up to Month 12 | The changes in levels of NfL protein in serum and its correlation with BMI will be analyzed using Pearson or Spearman correlation coefficients. |
| Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count | Up to Month 12 | 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. |
| Correlation Between NfL Protein Levels in Serum With No Evidence of Disease Activity-3 (NEDA-3) | Up to Month 12 | 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. |
| Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels | Up to Month 12 | The changes in levels of NfL protein in serum and its correlation with GFAP levels will be analyzed using Pearson or Spearman correlation coefficients. |
Countries
Germany, Switzerland
Contacts
CONTACTReference Study ID Number: ML45551 https://forpatients.roche.com/ No attachments to email below
CONTACTFastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed