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Multiple SclerosisSurfSubQNCT06780150

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

An observational study of Multiple Sclerosis, run by Hoffmann-La Roche at 93 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
How many people
842 participants
Where
93 sitesin 2 countries
Study dates
26 Sep 2024to 31 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), diagnosed according to McDonald criteria of 2017 or revised McDonald criteria 2024, and treated with ocrelizumab SC for the first time during routine clinical practice will be observed in this study.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

93 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

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

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

global-roche-genentech-trials@gene.com

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

93 sites in 2 countries

Germany91 sites, 84 recruiting

  • Uniklinik RWTH Aachen

    Aachen, 52074

    Recruiting

  • Gesundheitszentrum St. Marien GmbH

    Amberg, 92224

    Recruiting

  • Sächsisches Krankenhaus Arnsdorf

    Arnsdorf, 01477

    Recruiting

  • Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR

    Aschaffenburg, 63739

    Recruiting

  • Neurologie Bad Soden

    Bad Soden, 65812

    Recruiting

  • Neurologische Praxis - Kallmann Neurologie - mszb

    Bamberg, 96052

    Recruiting

  • Marianne-Strauß-klinik

    Berg, 82335

    Withdrawn

  • Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus

    Berlin, 10713

    Recruiting

  • NEUROZENTRUM tempelhof.berlin

    Berlin, 12099

    Recruiting

  • Praxis Dr. Said Masri

    Berlin, 12099

    Recruiting

  • Jüdisches Krankenhaus Berlin

    Berlin, 13347

    Recruiting

  • NeuroZentrum Zehlendorf Dr. Ringel und Dr. Scherer

    Berlin, 14169

    Recruiting

  • Neurologisches Zentrum für Bewegungsstörungen und Diagnostik

    Berlin, 14195

    Recruiting

  • St. Josef-Hospital

    Bochum, 44791

    Recruiting

  • Dres. Lippert/Kausch

    Bogen, 94327

    Recruiting

  • Krankenhaus Buchholz Abt. Neurologie

    Buchholz, 21244

    Withdrawn

  • Allgemeines Krankenhaus Celle / Klinik für Neurologie

    Celle, 29223

    Recruiting

  • Neuropraxis Celle: Praxis für Neurologie & Psychatrie

    Celle, 29223

    Recruiting

  • Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov

    Chemnitz, 09117

    Active, not recruiting

  • NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus

    Cologne, 50935

    Recruiting

  • Gemeinschaftspraxis Dr. med. Josef Leclaire und Dr. med. Thomas Rotermund

    Dortmund, 44137

    Withdrawn

  • Gemeinschaftspraxis für Neurologie

    Düsseldorf, 40211

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

    Recruiting

  • Nervenarztpraxis Gerresheim

    Düsseldorf, 40625

    Withdrawn

  • Gemeinschaftspraxis für Neurologie und Psychiatrie, Psychotherapie

    Eltville, 65343

    Recruiting

  • NeuroCentrum Odenwald

    Erbach/Odenwald, 64711

    Recruiting

  • Universitätsklinikum Erlangen, Neurologische Klinik

    Erlangen, 91054

    Recruiting

  • Zentrum für ambulante Neurologie / Praxis Knorn Landefeld Friedrich

    Essen, 45138

    Recruiting

  • Praxis Nervenstark

    Essen, 45257

    Recruiting

  • Praxis für Neurologie, Nervenheilkunde & Neurochirurgie

    Forchheim, 91301

    Completed

  • Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

    Frankfurt, 60528

    Recruiting

  • Varisano Klinikum Frankfurt Höchst GmbH

    Frankfurt, 65929

    Recruiting

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106

    Recruiting

  • Praxis im Bahnhof

    Füssen, 87629

    Recruiting

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392

    Recruiting

  • Neurologie & Psychiatrie Gladenbach - MS-Zentrum

    Gladenbach, 35075

    Recruiting

  • MVZ Bezirkskliniken Schwaben, Standort Günzburg

    Günzburg, 89312

    Recruiting

  • Krankenhaus Martha-Maria Halle-Doelau

    Halle, 06120

    Recruiting

  • Universiätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Recruiting

  • Neurologische Praxis Eppendorf

    Hamburg, 20249

    Recruiting

  • Neurologische Praxis

    Hanover, 30171

    Recruiting

  • Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie

    Hennigsdorf, 16761

    Recruiting

  • Praxis Dr. Hospely

    Herford, 32052

    Recruiting

  • Haus- und Facharztzentrum Laucherttal / Alb

    Hettingen, 72513

    Recruiting

  • Klinikum Ibbenbüren gmbH

    Ibbenbueren, 49477

    Recruiting

  • Augustahospital Anholt;Neurologie

    Isselburg, 46419

    Recruiting

  • Universitätsklinikum Jena, Klinik für Neurologie

    Jena, 07747

    Recruiting

  • Uniklinik Schleswig-Holstein

    Kiel, 24105

    Recruiting

  • Arztpraxis Dr. med. Torsten Sühnel

    Leipzig, 04299

    Recruiting

  • Neurologische Praxis Dr. Ehrlich

    Leipzig, 04315

    Recruiting

  • Universitätsklinik Schleswig Holstein, Campus Lübeck

    Lübeck, 23538

    Recruiting

  • Neurologie im Ulrichshaus Magdeburg

    Magdeburg, 39104

    Recruiting

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

    Recruiting

  • Neuroplus Dres. Lennart Thilmann/ Patrick Thilmann

    Mannheim, 68163

    Recruiting

  • Universitätsklinikum Mannheim

    Mannheim, 68167

    Recruiting

  • Universitätsklinikum Giessen und Marburg

    Marburg, 35043

    Recruiting

  • Praxis Dr. Leussink

    Meerbusch, 40667

    Recruiting

  • Neurologie am Preußenmuseum

    Minden, 32423

    Recruiting

  • Neurologie München Nord

    München, 80939

    Recruiting

  • Klinikum rechts der Isar der TU München

    München, 81675

    Recruiting

  • Praxis für Neurologie und Psychiatrie am Prinzregentenplatz

    München, 81675

    Recruiting

  • Universitätsklinikum Münster

    Münster, 48149

    Recruiting

  • Herz-Jesu-Krankenhaus Hiltrup GmbH

    Münster, 48165

    Recruiting

  • Neurologisch-psychiatrische Praxis im A4

    Neu-Ulm, 89231

    Recruiting

  • Praxis Dr. med. Bergmann

    Neuburg am Inn, 86633

    Recruiting

  • Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie

    Neuruppin, 16816

    Recruiting

  • Gemeinschaftspraxis Uhlig und Windsheimer

    Nuremberg, 90419

    Recruiting

  • Neurologie Nürnberg-Eibach

    Nuremberg, 90451

    Recruiting

  • Dres. Beckmann / Schlüter

    Öhringen, 74613

    Recruiting

  • Neurologie an der Hase

    Osnabrück, 49074

    Withdrawn

  • Facharztpraxis für Neurologie und Psychiatrie Dres Mattes/Stockert

    Pforzheim, 75172

    Recruiting

  • Neurologisches Studienzentrum Artland

    Quakenbrück, 49610

    Recruiting

  • Gemeinschaftspraxis für Neurologie

    Regensburg, 93059

    Recruiting

  • Gemeinschaftspraxis Dr. Stienker-Fisse & Dr. Fisse

    Remscheid, 42853

    Recruiting

  • ZNS Südpfalz

    Rülzheim, 76761

    Recruiting

  • Neurologische Praxis Dr. Wagner

    Schwetzingen, 68723

    Recruiting

  • Gemeinschaftspraxis für Neurologie, Psychiatrie und Psychotherapie

    Siegen, 57072

    Recruiting

  • Praxis für Neurologie und Psychiatrie

    Siegen, 57076

    Recruiting

  • EMSA - Zentrum für Neurologie?/?Psychiatrie?/?Neuroradiologie

    Singen, 78224

    Recruiting

  • Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim

    Sinsheim, 74889

    Recruiting

  • Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann

    Steglitz, 12163

    Recruiting

  • Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie

    Stuttgart, 70174

    Recruiting

  • Neuropraxis Sotiriadis

    Stuttgart, 70176

    Recruiting

  • Neurozentrum Stuttgart Mitte Sophienstraße

    Stuttgart, 70178

    Recruiting

  • Sauerlandklinik Hachen

    Sundern, 59846

    Recruiting

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076

    Recruiting

  • Nervenfachaerztliche Gemeinschaftspraxis Ulm

    Ulm, 89078

    Recruiting

  • Neuropraxis München Süd

    Unterhaching, 82008

    Recruiting

  • Praxis für Neurologie, Psychiatrie und Epileptologie

    Weil der Stadt, 71263

    Recruiting

  • Praxis Dr. Michaela Krause

    Wolfratshausen, 82515

    Recruiting

  • Heinrich-Braun-Krankenhaus Städtisches Klinikum

    Zwickau, 08060

    Recruiting

Other trials in Germany

Switzerland2 sites, 2 recruiting

  • Inselspital-Universitaetsspital Bern

    Bern, 3010

    Recruiting

  • Bellevue Medical Grop AG

    Zurich, 8001

    Recruiting

Other trials in Switzerland

About this study

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

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).

Being tested
Ocrelizumab
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

    Also called RO4964913, Ocrevus

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

Study groups in NCT06780150
Study groupRoleWhat they receive
OcrelizumabParticipants 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.
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants by Their Level of 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.

    Measured: Month 12

Secondary outcomes (18)

  1. Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After the First Injection and After 6 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.

    Measured: Baseline, Month 6

  2. Change From Baseline in NfL Protein Levels in Serum

    Measured: Baseline, Month 6, Month 12

  3. Concentration of NfL Protein Levels in Serum

    Measured: Baseline, Month 6, Month 12

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

    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.

    Measured: Up to Month 12

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

    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.

    Measured: Up to Month 12

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

    The changes in levels of NfL protein in serum and its correlation with DMT will be analyzed using Pearson or Spearman correlation coefficients.

    Measured: Up to Month 12

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

    The changes in levels of NfL protein in serum and its correlation with serum creatinine will be analyzed using Pearson or Spearman correlation coefficients.

    Measured: Up to Month 12

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

    The changes in levels of NfL protein in serum and its correlation with co-morbidities will be analyzed using Pearson or Spearman correlation coefficients.

    Measured: Up to Month 12

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

    The changes in levels of NfL protein in serum and its correlation with age will be analyzed using Pearson or Spearman correlation coefficients.

    Measured: Up to Month 12

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

    The changes in levels of NfL protein in serum and its correlation with BMI will be analyzed using Pearson or Spearman correlation coefficients.

    Measured: Up to Month 12

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

    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.

    Measured: Up to Month 12

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

    The changes in levels of NfL protein in serum and its correlation with GFAP levels will be analyzed using Pearson or Spearman correlation coefficients.

    Measured: Up to Month 12

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

    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.

    Measured: Up to Month 12

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

    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.

    Measured: Baseline, Month 6, Month 12

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

    Measured: Baseline, Month 6, Month 12

  16. Annualized Relapse Rate

    Measured: Month 12

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

    Measured: 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)

    Measured: Up to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start26 Sep 2024
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
842 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06780150
Sponsor's protocol ID
ML45551
Acronym
SurfSubQ
Status last verified
Oct 2026
First submitted
13 Jan 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Hoffmann-La Roche at 93 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: ML45551 https://forpatients.roche.com/ No attachments to email below (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06780150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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