A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: Ocrelizumab

• Registration Number: NCT06780150
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneous (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-26
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 349

Inclusion Criteria

• Diagnosis of MS
• RMS and PPMS participants diagnosed according to the McDonald criteria of 2017
• 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 and/or breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ocrelizumab	Ocrelizumab	Participants who are receiving ocrelizumab, SC injection, for the first time as part of their routine MS therapy at physician's discretion in accordance with local clinical practice and/or labeling will be observed for treatment satisfaction with SC injection for up to 12 months.

Primary Outcome Measures

Name	Time	Method
Number of Participants Their Level of by 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 Outcome Measures

Name	Time	Method
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	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 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.
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.
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
Change From Baseline in Participant Satisfaction With Ocrelizumab SC Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4	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

Trial Locations

Locations (58)

Uniklinik RWTH Aachen; 🇩🇪 Aachen, Germany

Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR; 🇩🇪 Aschaffenburg, Germany

Neurologie Bad Soden; 🇩🇪 Bad Soden, Germany

Neurologische Praxis - Kallmann Neurologie - mszb; 🇩🇪 Bamberg, Germany

Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann; 🇩🇪 Berlin-Steglitz, Germany

Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus; 🇩🇪 Berlin, Germany

Praxis Dr. Said Masri; 🇩🇪 Berlin, Germany

Jüdisches Krankenhaus Berlin; 🇩🇪 Berlin, Germany

St. Josef-Hospital; 🇩🇪 Bochum, Germany

Dres. Lippert/Kausch; 🇩🇪 Bogen, Germany

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