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Recruiting NCT06780150

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

— Observational Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ocrelizumab.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

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

Primary outcome measures

  • Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC [Time frame: Month 12]
Secondary outcome measures (12)
  • 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]
  • Change From Baseline in NfL Protein Levels in Serum [Time frame: Baseline, Month 6, Month 12]
  • Concentration of NfL Protein Levels in Serum [Time frame: Baseline, Month 6, Month 12]
  • Correlation Between NfL Protein Levels in Serum With MS Relapse [Time frame: Up to Month 12]
  • Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS) [Time frame: Up to Month 12]
  • Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT) [Time frame: Up to Month 12]
  • Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine [Time frame: Up to Month 12]
  • Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities [Time frame: Up to Month 12]
  • Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age [Time frame: Up to Month 12]
  • Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI] [Time frame: Up to Month 12]
  • Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count [Time frame: Up to Month 12]
  • Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels [Time frame: Up to Month 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 90 centers
  • Uniklinik RWTH Aachen — Aachen
  • Gesundheitszentrum St. Marien GmbH — Amberg
  • Sächsisches Krankenhaus Arnsdorf — Arnsdorf
  • Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR — Aschaffenburg
  • Neurologie Bad Soden — Bad Soden
  • Neurologische Praxis - Kallmann Neurologie - mszb — Bamberg
  • Marianne-Strauß-klinik — Berg
  • Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus — Berlin
  • … and 82 more centers
Switzerland · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06780150 · ML45551

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗