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NCT Number: NCT06780150

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

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniklinik RWTH Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocrelizumab

Drug

Ocrelizumab will be administered as SC injection as per discretion of the treating physician in accordance with local clinical practice and local labeling.

Other names: RO4964913, Ocrevus

Primary outcomes

  1. Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC

    Time frame: 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 outcomes

  1. Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After the First Injection and After 6 Months Assessed Using TASQ-SC

    Time frame: 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.

  2. Change From Baseline in NfL Protein Levels in Serum

    Time frame: Baseline, Month 6, Month 12

  3. Concentration of NfL Protein Levels in Serum

    Time frame: Baseline, Month 6, Month 12

  4. Correlation Between NfL Protein Levels in Serum With MS Relapse

    Time frame: 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.

  5. Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS)

    Time frame: 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.

  6. Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT)

    Time frame: 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.

  7. Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine

    Time frame: 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.

  8. Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities

    Time frame: 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.

  9. Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age

    Time frame: 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.

  10. Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI]

    Time frame: 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.

  11. Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count

    Time frame: 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.

  12. Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels

    Time frame: 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.

  13. Correlation Between NfL Protein Levels in Serum With No Evidence of Disease Activity-3 (NEDA-3)

    Time frame: 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.

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

    Time frame: 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.

  15. Number of Participants by Their Level of Satisfaction With Ocrelizumab SC Assessed by Physician Survey

    Time frame: Baseline, Month 6, Month 12

  16. Annualized Relapse Rate

    Time frame: Month 12

  17. Percentage of Participants With Progression Independent of Relapse Activity (PIRA)

    Time frame: Up to Month 12

  18. Number of Participants With Non-serious Adverse Events (nsAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)

    Time frame: Up to Month 12

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: ML45551 https://forpatients.roche.com/ No attachments to email below

CONTACT

[email protected]

888-662-6728 (U.S. Only)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

SurfSubQ - A Prospective Longitudinal Multicenter Observational Study to Investigate Neurofilament Light Chain Levels and Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Multiple Sclerosis

Acronym: SurfSubQ

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 17, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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