Clinical trial NCT06780150: A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 during routine clinical practice will be observed in this study.

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).


Eligibility 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 and/or breastfeeding women

Primary outcomes:
measure: Number of Participants Their Level of by Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC
timeFrame: Month 12
Secondary outcomes:
measure: Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After the First Injection and After 6 Months Assessed Using TASQ-SC
timeFrame: Baseline, Month 6
measure: Change From Baseline in NfL Protein Levels in Serum
timeFrame: Month 6, Month 12
measure: Concentration of NfL Protein Levels in Serum
timeFrame: Baseline, Month 6, Month 12
measure: Correlation Between NfL Protein Levels in Serum With MS Relapse
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS)
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT)
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI]
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels
timeFrame: Up to Month 12
measure: Correlation Between NfL Protein Levels in Serum With No Evidence of Disease Activity-3 (NEDA-3)
timeFrame: Up to Month 12
measure: Change From Baseline in Participant Satisfaction With Ocrelizumab SC Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4
timeFrame: Month 6, Month 12
measure: Number of Participants by Their Level of Satisfaction With Ocrelizumab SC Assessed by Physician Survey
timeFrame: Baseline, Month 6, Month 12
measure: Annualized Relapse Rate
timeFrame: Month 12
measure: Percentage of Participants With Progression Independent of Relapse Activity (PIRA)
timeFrame: Up to Month 12
measure: Number of Participants With Non-serious Adverse Events (nsAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
city: Aschaffenburg
country: Germany
facility: Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR
city: Bamberg
country: Germany
facility: Neurologische Praxis - Kallmann Neurologie - mszb
city: Berlin-Steglitz
country: Germany
facility: Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
city: Berlin
country: Germany
facility: Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus
city: Berlin
country: Germany
facility: Praxis Dr. Said Masri
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus Berlin
city: Bochum
country: Germany
facility: St. Josef-Hospital
city: Bogen
country: Germany
facility: Dres. Lippert/Kausch
city: Buchholz
country: Germany
facility: Krankenhaus Buchholz Abt. Neurologie
city: Celle
country: Germany
facility: Neuropraxis Celle: Praxis für Neurologie & Psychatrie
city: Chemnitz
country: Germany
facility: Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov
city: Dortmund
country: Germany
facility: Gemeinschaftspraxis Dr. med. Josef Leclaire und Dr. med. Thomas Rotermund
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis für Neurologie
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Eltville
country: Germany
facility: Gemeinschaftspraxis für Neurologie und Psychiatrie, Psychotherapie
city: Erbach/Odenwald
country: Germany
facility: NeuroCentrum Odenwald
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Neurologische Klinik
city: Essen
country: Germany
facility: Zentrum für ambulante Neurologie / Praxis Knorn Landefeld Friedrich
city: Forchheim
country: Germany
facility: Praxis für Neurologie, Nervenheilkunde & Neurochirurgie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
city: Gladenbach
country: Germany
facility: Neurologie & Psychiatrie Gladenbach - MS-Zentrum
city: Hamburg
country: Germany
facility: Neurologische Praxis Eppendorf
city: Hannover
country: Germany
facility: Neurologische Praxis
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie
city: Herford
country: Germany
facility: Praxis Dr. Hospely
city: Ibbenbüren
country: Germany
facility: Klinikum Ibbenbüren gmbH
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Neurologie
city: Köln
country: Germany
facility: NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus
city: Leipzig
country: Germany
facility: Arztpraxis Dr. med. Torsten Sühnel
city: Leipzig
country: Germany
facility: Neurologische Praxis Dr. Ehrlich
city: Magdeburg
country: Germany
facility: Neurologie im Ulrichshaus Magdeburg
city: Mannheim
country: Germany
facility: Neuroplus Dres. Lennart Thilmann/ Patrick Thilmann
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg
city: Meerbusch
country: Germany
facility: Praxis Dr. Leussink
city: Minden
country: Germany
facility: Neurologie am Preußenmuseum
city: München
country: Germany
facility: Neurologie München Nord
city: München
country: Germany
facility: Praxis für Neurologie und Psychiatrie am Prinzregentenplatz
city: Neu - Ulm
country: Germany
facility: Neurologisch-psychiatrische Praxis im A4
city: Neuburg
country: Germany
facility: Praxis Dr. med. Bergmann
city: Nürnberg
country: Germany
facility: Neurologie Nürnberg-Eibach
city: Pforzheim
country: Germany
facility: Facharztpraxis für Neurologie und Psychiatrie Dres Mattes/Stockert
city: Quakenbrück
country: Germany
facility: Neurologisches Studienzentrum Artland
city: Regensburg
country: Germany
facility: Gemeinschaftspraxis für Neurologie
city: Remscheid
country: Germany
facility: Praxis Dr. Stienker-Fisse
city: Schwetzingen
country: Germany
facility: Neurologische Praxis Dr. Wagner
city: Siegen
country: Germany
facility: Gemeinschaftspraxis für Neurologie, Psychiatrie und Psychotherapie
city: Siegen
country: Germany
facility: Praxis für Neurologie und Psychiatrie
city: Singen
country: Germany
facility: EMSA - Zentrum für Neurologie?/?Psychiatrie?/?Neuroradiologie
city: Stuttgart
country: Germany
facility: Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Zentrum für Neurologie
city: Ulm
country: Germany
facility: Nervenfachaerztliche Gemeinschaftspraxis Ulm
city: Unterhaching
country: Germany
facility: Neuropraxis München Süd
city: Weil der Stadt
country: Germany
facility: Praxis für Neurologie, Psychiatrie und Epileptologie
city: Wolfratshausen
country: Germany
facility: Praxis Dr. Michaela Krause
city: Zwickau
country: Germany
facility: Heinrich-Braun-Krankenhaus Städtisches Klinikum
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: