A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)
SurfSubQ
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
1 other identifier
observational
842
2 countries
90
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
Typical duration for all trials
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2024
CompletedFirst Submitted
Initial submission to the registry
January 13, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
May 27, 2026
May 1, 2026
3.5 years
January 13, 2025
May 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Their Level of by Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC
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.
Month 12
Secondary Outcomes (18)
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
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
Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS)
Up to Month 12
- +13 more secondary outcomes
Study Arms (1)
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.
Interventions
Ocrelizumab will be administered as SC injection as per discretion of the treating physician in accordance with local clinical practice and local labeling.
Eligibility Criteria
Participants with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), diagnosed according to McDonald criteria of 2017, and treated with ocrelizumab SC for the first time during routine clinical practice will be observed in this study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (90)
Uniklinik RWTH Aachen
Aachen, 52074, Germany
Gesundheitszentrum St. Marien GmbH
Amberg, 92224, Germany
Sächsisches Krankenhaus Arnsdorf
Arnsdorf, 01477, Germany
Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR
Aschaffenburg, 63739, Germany
Neurologie Bad Soden
Bad Soden, 65812, Germany
Neurologische Praxis - Kallmann Neurologie - mszb
Bamberg, 96052, Germany
Marianne-Strauß-klinik
Berg, 82335, Germany
Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus
Berlin, 10713, Germany
NEUROZENTRUM tempelhof.berlin
Berlin, 12099, Germany
Praxis Dr. Said Masri
Berlin, 12099, Germany
Jüdisches Krankenhaus Berlin
Berlin, 13347, Germany
NeuroZentrum Zehlendorf Dr. Ringel und Dr. Scherer
Berlin, 14169, Germany
Neurologisches Zentrum für Bewegungsstörungen und Diagnostik
Berlin, 14195, Germany
St. Josef-Hospital
Bochum, 44791, Germany
Dres. Lippert/Kausch
Bogen, 94327, Germany
Krankenhaus Buchholz Abt. Neurologie
Buchholz, 21244, Germany
Allgemeines Krankenhaus Celle / Klinik für Neurologie
Celle, 29223, Germany
Neuropraxis Celle: Praxis für Neurologie & Psychatrie
Celle, 29223, Germany
Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov
Chemnitz, 09117, Germany
NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus
Cologne, 50935, Germany
Gemeinschaftspraxis Dr. med. Josef Leclaire und Dr. med. Thomas Rotermund
Dortmund, 44137, Germany
Gemeinschaftspraxis für Neurologie
Düsseldorf, 40211, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Nervenarztpraxis Gerresheim
Düsseldorf, 40625, Germany
Gemeinschaftspraxis für Neurologie und Psychiatrie, Psychotherapie
Eltville, 65343, Germany
NeuroCentrum Odenwald
Erbach/Odenwald, 64711, Germany
Universitätsklinikum Erlangen, Neurologische Klinik
Erlangen, 91054, Germany
Zentrum für ambulante Neurologie / Praxis Knorn Landefeld Friedrich
Essen, 45138, Germany
Praxis Nervenstark
Essen, 45257, Germany
Praxis für Neurologie, Nervenheilkunde & Neurochirurgie
Forchheim, 91301, Germany
Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
Frankfurt, 60528, Germany
Varisano Klinikum Frankfurt Höchst GmbH
Frankfurt, 65929, Germany
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Freiburg im Breisgau, 79106, Germany
Praxis im Bahnhof
Füssen, 87629, Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392, Germany
Neurologie & Psychiatrie Gladenbach - MS-Zentrum
Gladenbach, 35075, Germany
MVZ Bezirkskliniken Schwaben, Standort Günzburg
Günzburg, 89312, Germany
Krankenhaus Martha-Maria Halle-Doelau
Halle, 06120, Germany
Universiätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Neurologische Praxis Eppendorf
Hamburg, 20249, Germany
Neurologische Praxis
Hanover, 30171, Germany
Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie
Hennigsdorf, 16761, Germany
Praxis Dr. Hospely
Herford, 32052, Germany
Haus- und Facharztzentrum Laucherttal / Alb
Hettingen, 72513, Germany
Klinikum Ibbenbüren gmbH
Ibbenbueren, 49477, Germany
Augustahospital Anholt;Neurologie
Isselburg, 46419, Germany
Universitätsklinikum Jena, Klinik für Neurologie
Jena, 07747, Germany
Uniklinik Schleswig-Holstein
Kiel, 24105, Germany
Arztpraxis Dr. med. Torsten Sühnel
Leipzig, 04299, Germany
Neurologische Praxis Dr. Ehrlich
Leipzig, 04315, Germany
Neurologie im Ulrichshaus Magdeburg
Magdeburg, 39104, Germany
Universitätsklinikum Magdeburg
Magdeburg, 39120, Germany
Neuroplus Dres. Lennart Thilmann/ Patrick Thilmann
Mannheim, 68163, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
Universitätsklinikum Giessen und Marburg
Marburg, 35043, Germany
Praxis Dr. Leussink
Meerbusch, 40667, Germany
Neurologie am Preußenmuseum
Minden, 32423, Germany
Neurologie München Nord
München, 80939, Germany
Klinikum rechts der Isar der TU München
München, 81675, Germany
Praxis für Neurologie und Psychiatrie am Prinzregentenplatz
München, 81675, Germany
Herz-Jesu-Krankenhaus Hiltrup GmbH
Münster, 48165, Germany
Neurologisch-psychiatrische Praxis im A4
Neu-Ulm, 89231, Germany
Praxis Dr. med. Bergmann
Neuburg am Inn, 86633, Germany
Gemeinschaftspraxis Uhlig und Windsheimer
Nuremberg, 90419, Germany
Neurologie Nürnberg-Eibach
Nuremberg, 90451, Germany
Neurologie an der Hase
Osnabrück, 49074, Germany
Dres. Beckmann / Schlüter
Öhringen, 74613, Germany
Facharztpraxis für Neurologie und Psychiatrie Dres Mattes/Stockert
Pforzheim, 75172, Germany
Neurologisches Studienzentrum Artland
Quakenbrück, 49610, Germany
Gemeinschaftspraxis für Neurologie
Regensburg, 93059, Germany
Praxis Dr. Stienker-Fisse
Remscheid, 42853, Germany
ZNS Südpfalz
Rülzheim, 76761, Germany
Neurologische Praxis Dr. Wagner
Schwetzingen, 68723, Germany
Gemeinschaftspraxis für Neurologie, Psychiatrie und Psychotherapie
Siegen, 57072, Germany
Praxis für Neurologie und Psychiatrie
Siegen, 57076, Germany
EMSA - Zentrum für Neurologie?/?Psychiatrie?/?Neuroradiologie
Singen, 78224, Germany
Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim
Sinsheim, 74889, Germany
Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
Steglitz, 12163, Germany
Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
Stuttgart, 70174, Germany
Neuropraxis Sotiriadis
Stuttgart, 70176, Germany
Neurozentrum Stuttgart Mitte Sophienstraße
Stuttgart, 70178, Germany
Sauerlandklinik Hachen
Sundern, 59846, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076, Germany
Nervenfachaerztliche Gemeinschaftspraxis Ulm
Ulm, 89078, Germany
Neuropraxis München Süd
Unterhaching, 82008, Germany
Praxis für Neurologie, Psychiatrie und Epileptologie
Weil der Stadt, 71263, Germany
Praxis Dr. Michaela Krause
Wolfratshausen, 82515, Germany
Heinrich-Braun-Krankenhaus Städtisches Klinikum
Zwickau, 08060, Germany
Inselspital-Universitaetsspital Bern
Bern, 3010, Switzerland
Bellevue Medical Grop AG
Zurich, 8001, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: ML45551 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2025
First Posted
January 17, 2025
Study Start
September 26, 2024
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
May 27, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing