Investigating the effects of ocrelizumab on neurofilament levels and patient satisfaction in multiple sclerosis
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
This study is testing how the medication ocrelizumab affects certain markers in the blood and how satisfied people with multiple sclerosis feel about their treatment after a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 842 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | ocrelizumab, rituximab, ublituximab |
| Locations | 84 sites (Aachen and 83 other locations) |
| Trial ID | NCT06780150 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of ocrelizumab treatment on neurofilament light chain (NfL) levels and participant satisfaction after 12 months of therapy. Participants diagnosed with multiple sclerosis, including relapsing and primary progressive forms, will be assessed using a therapy administration satisfaction questionnaire. The study focuses on individuals receiving their first treatment with ocrelizumab subcutaneously, following local prescribing guidelines. By monitoring these outcomes, the study seeks to provide insights into the treatment's impact on both biological markers and patient experience.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with multiple sclerosis who are starting their first treatment with ocrelizumab.
Not a fit: Patients who have previously received treatment with rituximab or ublituximab, or those participating in other interventional studies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how ocrelizumab affects both neurobiological markers and patient satisfaction, potentially improving treatment approaches for multiple sclerosis.
How similar studies have performed: While this study focuses on a specific treatment and patient satisfaction, similar studies have shown promising results in evaluating treatment effects in multiple sclerosis.
Eligibility criteria
Show full inclusion / exclusion criteria
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 women
Where this trial is running
Aachen and 83 other locations
- Uniklinik RWTH Aachen — Aachen, Germany (Recruiting)
- Gesundheitszentrum St. Marien GmbH — Amberg, Germany (Recruiting)
- Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR — Aschaffenburg, Germany (Recruiting)
- Neurologie Bad Soden — Bad Soden, Germany (Recruiting)
- Neurologische Praxis - Kallmann Neurologie - mszb — Bamberg, Germany (Recruiting)
- Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus — Berlin, Germany (Recruiting)
- NEUROZENTRUM tempelhof.berlin — Berlin, Germany (Recruiting)
- Praxis Dr. Said Masri — Berlin, Germany (Recruiting)
- Jüdisches Krankenhaus Berlin — Berlin, Germany (Recruiting)
- NeuroZentrum Zehlendorf Dr. Ringel und Dr. Scherer — Berlin, Germany (Recruiting)
- Neurologisches Zentrum für Bewegungsstörungen und Diagnostik — Berlin, Germany (Recruiting)
- St. Josef-Hospital — Bochum, Germany (Recruiting)
- Dres. Lippert/Kausch — Bogen, Germany (Recruiting)
- Krankenhaus Buchholz Abt. Neurologie — Buchholz, Germany (Recruiting)
- Allgemeines Krankenhaus Celle / Klinik für Neurologie — Celle, Germany (Recruiting)
- Neuropraxis Celle: Praxis für Neurologie & Psychatrie — Celle, Germany (Recruiting)
- Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov — Chemnitz, Germany (Recruiting)
- NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus — Cologne, Germany (Recruiting)
- Gemeinschaftspraxis Dr. med. Josef Leclaire und Dr. med. Thomas Rotermund — Dortmund, Germany (Withdrawn)
- Gemeinschaftspraxis für Neurologie — Düsseldorf, Germany (Recruiting)
- Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Recruiting)
- Nervenarztpraxis Gerresheim — Düsseldorf, Germany (Recruiting)
- Gemeinschaftspraxis für Neurologie und Psychiatrie, Psychotherapie — Eltville, Germany (Recruiting)
- NeuroCentrum Odenwald — Erbach/Odenwald, Germany (Recruiting)
- Universitätsklinikum Erlangen, Neurologische Klinik — Erlangen, Germany (Recruiting)
- Zentrum für ambulante Neurologie / Praxis Knorn Landefeld Friedrich — Essen, Germany (Recruiting)
- Praxis Nervenstark — Essen, Germany (Recruiting)
- Praxis für Neurologie, Nervenheilkunde & Neurochirurgie — Forchheim, Germany (Withdrawn)
- Varisano Klinikum Frankfurt Höchst GmbH — Frankfurt, Germany (Recruiting)
- Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie — Freiburg im Breisgau, Germany (Recruiting)
- Praxis im Bahnhof — Füssen, Germany (Recruiting)
- Universitätsklinikum Gießen und Marburg GmbH — Giessen, Germany (Recruiting)
- Neurologie & Psychiatrie Gladenbach - MS-Zentrum — Gladenbach, Germany (Recruiting)
- MVZ Bezirkskliniken Schwaben, Standort Günzburg — Günzburg, Germany (Recruiting)
- Krankenhaus Martha-Maria Halle-Doelau — Halle, Germany (Recruiting)
- Universiätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Neurologische Praxis Eppendorf — Hamburg, Germany (Recruiting)
- Neurologische Praxis — Hanover, Germany (Recruiting)
- Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie — Hennigsdorf, Germany (Recruiting)
- Praxis Dr. Hospely — Herford, Germany (Recruiting)
- Haus- und Facharztzentrum Laucherttal / Alb — Hettingen, Germany (Recruiting)
- Klinikum Ibbenbüren gmbH — Ibbenbueren, Germany (Recruiting)
- Augustahospital Anholt;Neurologie — Isselburg, Germany (Recruiting)
- Universitätsklinikum Jena, Klinik für Neurologie — Jena, Germany (Recruiting)
- Arztpraxis Dr. med. Torsten Sühnel — Leipzig, Germany (Recruiting)
- Neurologische Praxis Dr. Ehrlich — Leipzig, Germany (Recruiting)
- Neurologie im Ulrichshaus Magdeburg — Magdeburg, Germany (Recruiting)
- Universitätsklinikum Magdeburg — Magdeburg, Germany (Recruiting)
- Neuroplus Dres. Lennart Thilmann/ Patrick Thilmann — Mannheim, Germany (Recruiting)
- Universitätsklinikum Mannheim — Mannheim, Germany (Recruiting)
+34 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Reference Study ID Number: ML45551 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. Only)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.