NCT06780150

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

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
842

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Sep 2024

Typical duration for all trials

Geographic Reach
2 countries

90 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Sep 2024Mar 2028

Study Start

First participant enrolled

September 26, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

3.5 years

First QC Date

January 13, 2025

Last Update Submit

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.

Drug: Ocrelizumab

Interventions

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

Also known as: RO4964913, Ocrevus
Ocrelizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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 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

RECRUITING

Gesundheitszentrum St. Marien GmbH

Amberg, 92224, Germany

RECRUITING

Sächsisches Krankenhaus Arnsdorf

Arnsdorf, 01477, Germany

RECRUITING

Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR

Aschaffenburg, 63739, Germany

RECRUITING

Neurologie Bad Soden

Bad Soden, 65812, Germany

RECRUITING

Neurologische Praxis - Kallmann Neurologie - mszb

Bamberg, 96052, Germany

RECRUITING

Marianne-Strauß-klinik

Berg, 82335, Germany

RECRUITING

Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus

Berlin, 10713, Germany

RECRUITING

NEUROZENTRUM tempelhof.berlin

Berlin, 12099, Germany

RECRUITING

Praxis Dr. Said Masri

Berlin, 12099, Germany

RECRUITING

Jüdisches Krankenhaus Berlin

Berlin, 13347, Germany

RECRUITING

NeuroZentrum Zehlendorf Dr. Ringel und Dr. Scherer

Berlin, 14169, Germany

RECRUITING

Neurologisches Zentrum für Bewegungsstörungen und Diagnostik

Berlin, 14195, Germany

RECRUITING

St. Josef-Hospital

Bochum, 44791, Germany

RECRUITING

Dres. Lippert/Kausch

Bogen, 94327, Germany

RECRUITING

Krankenhaus Buchholz Abt. Neurologie

Buchholz, 21244, Germany

WITHDRAWN

Allgemeines Krankenhaus Celle / Klinik für Neurologie

Celle, 29223, Germany

RECRUITING

Neuropraxis Celle: Praxis für Neurologie & Psychatrie

Celle, 29223, Germany

RECRUITING

Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov

Chemnitz, 09117, Germany

RECRUITING

NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus

Cologne, 50935, Germany

RECRUITING

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

Dortmund, 44137, Germany

WITHDRAWN

Gemeinschaftspraxis für Neurologie

Düsseldorf, 40211, Germany

RECRUITING

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

RECRUITING

Nervenarztpraxis Gerresheim

Düsseldorf, 40625, Germany

RECRUITING

Gemeinschaftspraxis für Neurologie und Psychiatrie, Psychotherapie

Eltville, 65343, Germany

RECRUITING

NeuroCentrum Odenwald

Erbach/Odenwald, 64711, Germany

RECRUITING

Universitätsklinikum Erlangen, Neurologische Klinik

Erlangen, 91054, Germany

RECRUITING

Zentrum für ambulante Neurologie / Praxis Knorn Landefeld Friedrich

Essen, 45138, Germany

RECRUITING

Praxis Nervenstark

Essen, 45257, Germany

RECRUITING

Praxis für Neurologie, Nervenheilkunde & Neurochirurgie

Forchheim, 91301, Germany

COMPLETED

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

Frankfurt, 60528, Germany

RECRUITING

Varisano Klinikum Frankfurt Höchst GmbH

Frankfurt, 65929, Germany

RECRUITING

Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

Freiburg im Breisgau, 79106, Germany

RECRUITING

Praxis im Bahnhof

Füssen, 87629, Germany

RECRUITING

Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35392, Germany

RECRUITING

Neurologie & Psychiatrie Gladenbach - MS-Zentrum

Gladenbach, 35075, Germany

RECRUITING

MVZ Bezirkskliniken Schwaben, Standort Günzburg

Günzburg, 89312, Germany

RECRUITING

Krankenhaus Martha-Maria Halle-Doelau

Halle, 06120, Germany

RECRUITING

Universiätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Neurologische Praxis Eppendorf

Hamburg, 20249, Germany

RECRUITING

Neurologische Praxis

Hanover, 30171, Germany

RECRUITING

Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie

Hennigsdorf, 16761, Germany

RECRUITING

Praxis Dr. Hospely

Herford, 32052, Germany

RECRUITING

Haus- und Facharztzentrum Laucherttal / Alb

Hettingen, 72513, Germany

RECRUITING

Klinikum Ibbenbüren gmbH

Ibbenbueren, 49477, Germany

RECRUITING

Augustahospital Anholt;Neurologie

Isselburg, 46419, Germany

RECRUITING

Universitätsklinikum Jena, Klinik für Neurologie

Jena, 07747, Germany

RECRUITING

Uniklinik Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

Arztpraxis Dr. med. Torsten Sühnel

Leipzig, 04299, Germany

RECRUITING

Neurologische Praxis Dr. Ehrlich

Leipzig, 04315, Germany

RECRUITING

Neurologie im Ulrichshaus Magdeburg

Magdeburg, 39104, Germany

RECRUITING

Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Neuroplus Dres. Lennart Thilmann/ Patrick Thilmann

Mannheim, 68163, Germany

RECRUITING

Universitätsklinikum Mannheim

Mannheim, 68167, Germany

RECRUITING

Universitätsklinikum Giessen und Marburg

Marburg, 35043, Germany

RECRUITING

Praxis Dr. Leussink

Meerbusch, 40667, Germany

RECRUITING

Neurologie am Preußenmuseum

Minden, 32423, Germany

RECRUITING

Neurologie München Nord

München, 80939, Germany

RECRUITING

Klinikum rechts der Isar der TU München

München, 81675, Germany

RECRUITING

Praxis für Neurologie und Psychiatrie am Prinzregentenplatz

München, 81675, Germany

RECRUITING

Herz-Jesu-Krankenhaus Hiltrup GmbH

Münster, 48165, Germany

RECRUITING

Neurologisch-psychiatrische Praxis im A4

Neu-Ulm, 89231, Germany

RECRUITING

Praxis Dr. med. Bergmann

Neuburg am Inn, 86633, Germany

RECRUITING

Gemeinschaftspraxis Uhlig und Windsheimer

Nuremberg, 90419, Germany

RECRUITING

Neurologie Nürnberg-Eibach

Nuremberg, 90451, Germany

RECRUITING

Neurologie an der Hase

Osnabrück, 49074, Germany

RECRUITING

Dres. Beckmann / Schlüter

Öhringen, 74613, Germany

RECRUITING

Facharztpraxis für Neurologie und Psychiatrie Dres Mattes/Stockert

Pforzheim, 75172, Germany

RECRUITING

Neurologisches Studienzentrum Artland

Quakenbrück, 49610, Germany

RECRUITING

Gemeinschaftspraxis für Neurologie

Regensburg, 93059, Germany

RECRUITING

Praxis Dr. Stienker-Fisse

Remscheid, 42853, Germany

RECRUITING

ZNS Südpfalz

Rülzheim, 76761, Germany

RECRUITING

Neurologische Praxis Dr. Wagner

Schwetzingen, 68723, Germany

RECRUITING

Gemeinschaftspraxis für Neurologie, Psychiatrie und Psychotherapie

Siegen, 57072, Germany

RECRUITING

Praxis für Neurologie und Psychiatrie

Siegen, 57076, Germany

RECRUITING

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

Singen, 78224, Germany

RECRUITING

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

Sinsheim, 74889, Germany

RECRUITING

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

Steglitz, 12163, Germany

RECRUITING

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

Stuttgart, 70174, Germany

RECRUITING

Neuropraxis Sotiriadis

Stuttgart, 70176, Germany

RECRUITING

Neurozentrum Stuttgart Mitte Sophienstraße

Stuttgart, 70178, Germany

RECRUITING

Sauerlandklinik Hachen

Sundern, 59846, Germany

RECRUITING

Universitätsklinikum Tübingen, Zentrum für Neurologie

Tübingen, 72076, Germany

RECRUITING

Nervenfachaerztliche Gemeinschaftspraxis Ulm

Ulm, 89078, Germany

RECRUITING

Neuropraxis München Süd

Unterhaching, 82008, Germany

RECRUITING

Praxis für Neurologie, Psychiatrie und Epileptologie

Weil der Stadt, 71263, Germany

RECRUITING

Praxis Dr. Michaela Krause

Wolfratshausen, 82515, Germany

RECRUITING

Heinrich-Braun-Krankenhaus Städtisches Klinikum

Zwickau, 08060, Germany

RECRUITING

Inselspital-Universitaetsspital Bern

Bern, 3010, Switzerland

RECRUITING

Bellevue Medical Grop AG

Zurich, 8001, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

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

Locations