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

September 11, 2026 updated by: Hoffmann-La Roche

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
842

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • Uniklinik RWTH Aachen
      • Amberg, Germany, 92224
        • Recruiting
        • Gesundheitszentrum St. Marien GmbH
      • Arnsdorf, Germany, 01477
        • Recruiting
        • Sächsisches Krankenhaus Arnsdorf
      • Aschaffenburg, Germany, 63739
        • Recruiting
        • Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR
      • Bad Soden, Germany, 65812
        • Recruiting
        • Neurologie Bad Soden
      • Bamberg, Germany, 96052
        • Recruiting
        • Neurologische Praxis - Kallmann Neurologie - mszb
      • Berg, Germany, 82335
        • Withdrawn
        • Marianne-Strauß-klinik
      • Berlin, Germany, 13347
        • Recruiting
        • Jüdisches Krankenhaus Berlin
      • Berlin, Germany, 12099
        • Recruiting
        • NEUROZENTRUM tempelhof.berlin
      • Berlin, Germany, 10713
        • Recruiting
        • Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus
      • Berlin, Germany, 12099
        • Recruiting
        • Praxis Dr. Said Masri
      • Berlin, Germany, 14169
        • Recruiting
        • NeuroZentrum Zehlendorf Dr. Ringel und Dr. Scherer
      • Berlin, Germany, 14195
        • Recruiting
        • Neurologisches Zentrum für Bewegungsstörungen und Diagnostik
      • Bochum, Germany, 44791
        • Recruiting
        • St. Josef-Hospital
      • Bogen, Germany, 94327
        • Recruiting
        • Dres. Lippert/Kausch
      • Buchholz, Germany, 21244
        • Withdrawn
        • Krankenhaus Buchholz Abt. Neurologie
      • Celle, Germany, 29223
        • Recruiting
        • Neuropraxis Celle: Praxis für Neurologie & Psychatrie
      • Celle, Germany, 29223
        • Recruiting
        • Allgemeines Krankenhaus Celle / Klinik für Neurologie
      • Chemnitz, Germany, 09117
        • Active, not recruiting
        • Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov
      • Cologne, Germany, 50935
        • Recruiting
        • NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus
      • Dortmund, Germany, 44137
        • Withdrawn
        • Gemeinschaftspraxis Dr. med. Josef Leclaire und Dr. med. Thomas Rotermund
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Universitätsklinikum Düsseldorf
      • Düsseldorf, Germany, 40211
        • Recruiting
        • Gemeinschaftspraxis für Neurologie
      • Düsseldorf, Germany, 40625
        • Withdrawn
        • Nervenarztpraxis Gerresheim
      • Eltville, Germany, 65343
        • Recruiting
        • Gemeinschaftspraxis für Neurologie und Psychiatrie, Psychotherapie
      • Erbach/Odenwald, Germany, 64711
        • Recruiting
        • NeuroCentrum Odenwald
      • Erlangen, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen, Neurologische Klinik
      • Essen, Germany, 45138
        • Recruiting
        • Zentrum für ambulante Neurologie / Praxis Knorn Landefeld Friedrich
      • Essen, Germany, 45257
        • Recruiting
        • Praxis Nervenstark
      • Forchheim, Germany, 91301
        • Completed
        • Praxis für Neurologie, Nervenheilkunde & Neurochirurgie
      • Frankfurt, Germany, 65929
        • Recruiting
        • Varisano Klinikum Frankfurt Höchst GmbH
      • Frankfurt, Germany, 60528
        • Recruiting
        • Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
      • Füssen, Germany, 87629
        • Recruiting
        • Praxis im Bahnhof
      • Giessen, Germany, 35392
        • Recruiting
        • Universitätsklinikum Gießen und Marburg GmbH
      • Gladenbach, Germany, 35075
        • Recruiting
        • Neurologie & Psychiatrie Gladenbach - MS-Zentrum
      • Günzburg, Germany, 89312
        • Recruiting
        • MVZ Bezirkskliniken Schwaben, Standort Günzburg
      • Halle, Germany, 06120
        • Recruiting
        • Krankenhaus Martha-Maria Halle-Doelau
      • Hamburg, Germany, 20249
        • Recruiting
        • Neurologische Praxis Eppendorf
      • Hamburg, Germany, 20246
        • Recruiting
        • Universiätsklinikum Hamburg-Eppendorf
      • Hanover, Germany, 30171
        • Recruiting
        • Neurologische Praxis
      • Hennigsdorf, Germany, 16761
        • Recruiting
        • Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie
      • Herford, Germany, 32052
        • Recruiting
        • Praxis Dr. Hospely
      • Hettingen, Germany, 72513
        • Recruiting
        • Haus- und Facharztzentrum Laucherttal / Alb
      • Ibbenbueren, Germany, 49477
        • Recruiting
        • Klinikum Ibbenbüren gmbH
      • Isselburg, Germany, 46419
        • Recruiting
        • Augustahospital Anholt;Neurologie
      • Jena, Germany, 07747
        • Recruiting
        • Universitätsklinikum Jena, Klinik für Neurologie
      • Kiel, Germany, 24105
        • Recruiting
        • Uniklinik Schleswig-Holstein
      • Leipzig, Germany, 04315
        • Recruiting
        • Neurologische Praxis Dr. Ehrlich
      • Leipzig, Germany, 04299
        • Recruiting
        • Arztpraxis Dr. med. Torsten Sühnel
      • Lübeck, Germany, 23538
        • Recruiting
        • Universitätsklinik Schleswig Holstein, Campus Lübeck
      • Magdeburg, Germany, 39120
        • Recruiting
        • Universitätsklinikum Magdeburg
      • Magdeburg, Germany, 39104
        • Recruiting
        • Neurologie im Ulrichshaus Magdeburg
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsklinikum Mannheim
      • Mannheim, Germany, 68163
        • Recruiting
        • Neuroplus Dres. Lennart Thilmann/ Patrick Thilmann
      • Marburg, Germany, 35043
        • Recruiting
        • Universitätsklinikum Giessen und Marburg
      • Meerbusch, Germany, 40667
        • Recruiting
        • Praxis Dr. Leussink
      • Minden, Germany, 32423
        • Recruiting
        • Neurologie am Preußenmuseum
      • München, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar der TU Munchen
      • München, Germany, 81675
        • Recruiting
        • Praxis für Neurologie und Psychiatrie am Prinzregentenplatz
      • München, Germany, 80939
        • Recruiting
        • Neurologie München Nord
      • Münster, Germany, 48165
        • Recruiting
        • Herz-Jesu-Krankenhaus Hiltrup GmbH
      • Neu-Ulm, Germany, 89231
        • Recruiting
        • Neurologisch-psychiatrische Praxis im A4
      • Neuburg am Inn, Germany, 86633
        • Recruiting
        • Praxis Dr. med. Bergmann
      • Neuruppin, Germany, 16816
        • Recruiting
        • Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie
      • Nuremberg, Germany, 90451
        • Recruiting
        • Neurologie Nürnberg-Eibach
      • Nuremberg, Germany, 90419
        • Recruiting
        • Gemeinschaftspraxis Uhlig und Windsheimer
      • Osnabrück, Germany, 49074
        • Withdrawn
        • Neurologie an der Hase
      • Pforzheim, Germany, 75172
        • Recruiting
        • Facharztpraxis für Neurologie und Psychiatrie Dres Mattes/Stockert
      • Quakenbrück, Germany, 49610
        • Recruiting
        • Neurologisches Studienzentrum Artland
      • Regensburg, Germany, 93059
        • Recruiting
        • Gemeinschaftspraxis für Neurologie
      • Remscheid, Germany, 42853
        • Recruiting
        • Gemeinschaftspraxis Dr. Stienker-Fisse & Dr. Fisse
      • Rülzheim, Germany, 76761
        • Recruiting
        • ZNS Südpfalz
      • Schwetzingen, Germany, 68723
        • Recruiting
        • Neurologische Praxis Dr. Wagner
      • Siegen, Germany, 57076
        • Recruiting
        • Praxis für Neurologie und Psychiatrie
      • Siegen, Germany, 57072
        • Recruiting
        • Gemeinschaftspraxis für Neurologie, Psychiatrie und Psychotherapie
      • Singen, Germany, 78224
        • Recruiting
        • EMSA - Zentrum für Neurologie?/?Psychiatrie?/?Neuroradiologie
      • Sinsheim, Germany, 74889
        • Recruiting
        • Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim
      • Steglitz, Germany, 12163
        • Recruiting
        • Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
      • Stuttgart, Germany, 70174
        • Recruiting
        • Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
      • Stuttgart, Germany, 70176
        • Recruiting
        • Neuropraxis Sotiriadis
      • Stuttgart, Germany, 70178
        • Recruiting
        • Neurozentrum Stuttgart Mitte Sophienstraße
      • Sundern, Germany, 59846
        • Recruiting
        • Sauerlandklinik Hachen
      • Tübingen, Germany, 72076
        • Recruiting
        • Universitätsklinikum Tübingen, Zentrum für Neurologie
      • Ulm, Germany, 89078
        • Recruiting
        • Nervenfachaerztliche Gemeinschaftspraxis Ulm
      • Unterhaching, Germany, 82008
        • Recruiting
        • Neuropraxis München Süd
      • Weil der Stadt, Germany, 71263
        • Recruiting
        • Praxis für Neurologie, Psychiatrie und Epileptologie
      • Wolfratshausen, Germany, 82515
        • Recruiting
        • Praxis Dr. Michaela Krause
      • Zwickau, Germany, 08060
        • Recruiting
        • Heinrich-Braun-Krankenhaus Städtisches Klinikum
      • Öhringen, Germany, 74613
        • Recruiting
        • Dres. Beckmann / Schlüter
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital-Universitaetsspital Bern
      • Zurich, Switzerland, 8001
        • Recruiting
        • Bellevue Medical Grop AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 or revised McDonald criteria 2024, and treated with ocrelizumab SC for the first time during routine clinical practice will be observed in this study.

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Ocrelizumab will be administered as SC injection as per discretion of the treating physician in accordance with local clinical practice and local labeling.
Other Names:
  • RO4964913, Ocrevus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC
Time Frame: Month 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After the First Injection and After 6 Months Assessed Using TASQ-SC
Time Frame: Baseline, Month 6
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.
Baseline, Month 6
Concentration of NfL Protein Levels in Serum
Time Frame: Baseline, Month 6, Month 12
Baseline, Month 6, Month 12
Correlation Between NfL Protein Levels in Serum With MS Relapse
Time Frame: Up to Month 12
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.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS)
Time Frame: Up to Month 12
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.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT)
Time Frame: Up to Month 12
The changes in levels of NfL protein in serum and its correlation with DMT will be analyzed using Pearson or Spearman correlation coefficients.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine
Time Frame: Up to Month 12
The changes in levels of NfL protein in serum and its correlation with serum creatinine will be analyzed using Pearson or Spearman correlation coefficients.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities
Time Frame: Up to Month 12
The changes in levels of NfL protein in serum and its correlation with co-morbidities will be analyzed using Pearson or Spearman correlation coefficients.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age
Time Frame: Up to Month 12
The changes in levels of NfL protein in serum and its correlation with age will be analyzed using Pearson or Spearman correlation coefficients.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI]
Time Frame: Up to Month 12
The changes in levels of NfL protein in serum and its correlation with BMI will be analyzed using Pearson or Spearman correlation coefficients.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count
Time Frame: Up to Month 12
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.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels
Time Frame: Up to Month 12
The changes in levels of NfL protein in serum and its correlation with GFAP levels will be analyzed using Pearson or Spearman correlation coefficients.
Up to Month 12
Correlation Between NfL Protein Levels in Serum With No Evidence of Disease Activity-3 (NEDA-3)
Time Frame: Up to Month 12
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.
Up to Month 12
Number of Participants by Their Level of Satisfaction With Ocrelizumab SC Assessed by Physician Survey
Time Frame: Baseline, Month 6, Month 12
Baseline, Month 6, Month 12
Annualized Relapse Rate
Time Frame: Month 12
Month 12
Percentage of Participants With Progression Independent of Relapse Activity (PIRA)
Time Frame: Up to Month 12
Up to Month 12
Number of Participants With Non-serious Adverse Events (nsAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)
Time Frame: Up to Month 12
Up to Month 12
Change From Baseline in NfL Protein Levels in Serum
Time Frame: Baseline, Month 6, Month 12
Baseline, Month 6, Month 12
Change From Baseline in Participant Satisfaction With Ocrelizumab SC Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4
Time Frame: Baseline, Month 6, Month 12
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.
Baseline, Month 6, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML45551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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