A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)
- Registration Number
- NCT06780150
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 349
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ocrelizumab 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.
- Primary Outcome Measures
Name Time Method Number of Participants Their Level of by Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
Correlation Between NfL Protein Levels in Serum With Expanded Disability Status Scale (EDSS) 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.
Correlation Between NfL Protein Levels in Serum With Previous MS Disease Modifying Therapy (DMT) 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.
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Serum Creatinine 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.
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Co-morbidities 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.
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Age 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.
Correlation Between NfL Protein Levels in Serum With NfL Confounder - Body Mass Index [BMI] 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.
Correlation Between NfL Protein Levels in Serum With Magnetic Resonance Imaging (MRI) Lesion Count 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.
Correlation Between NfL Protein Levels in Serum With Glial Fibrillary Acidic Protein (GFAP) Levels 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.
Correlation Between NfL Protein Levels in Serum With No Evidence of Disease Activity-3 (NEDA-3) 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.
Change From Baseline in Participant Satisfaction With Ocrelizumab SC Assessed Using Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4 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.
Number of Participants by Their Level of Satisfaction With Ocrelizumab SC Assessed by Physician Survey Baseline, Month 6, Month 12 Annualized Relapse Rate Month 12 Percentage of Participants With Progression Independent of Relapse Activity (PIRA) Up to Month 12 Number of Participants With Non-serious Adverse Events (nsAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs) Up to Month 12
Related Research Topics
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Trial Locations
- Locations (53)
Jüdisches Krankenhaus Berlin
🇩🇪Berlin, Germany
Dres. Lippert/Kausch
🇩🇪Bogen, Germany
Neurologie im Ulrichshaus Magdeburg
🇩🇪Magdeburg, Germany
Krankenhaus Buchholz Abt. Neurologie
🇩🇪Buchholz, Germany
Gemeinschaftspraxis Dr. med. Josef Leclaire und Dr. med. Thomas Rotermund
🇩🇪Dortmund, Germany
Zentrum für ambulante Neurologie / Praxis Knorn Landefeld Friedrich
🇩🇪Essen, Germany
Arztpraxis Dr. med. Torsten Sühnel
🇩🇪Leipzig, Germany
Uniklinik RWTH Aachen
🇩🇪Aachen, Germany
Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR
🇩🇪Aschaffenburg, Germany
Neurologische Praxis - Kallmann Neurologie - mszb
🇩🇪Bamberg, Germany
Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann
🇩🇪Berlin-Steglitz, Germany
Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus
🇩🇪Berlin, Germany
Praxis Dr. Said Masri
🇩🇪Berlin, Germany
St. Josef-Hospital
🇩🇪Bochum, Germany
Neuropraxis Celle: Praxis für Neurologie & Psychatrie
🇩🇪Celle, Germany
Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov
🇩🇪Chemnitz, Germany
Gemeinschaftspraxis für Neurologie
🇩🇪Regensburg, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Gemeinschaftspraxis für Neurologie und Psychiatrie, Psychotherapie
🇩🇪Eltville, Germany
NeuroCentrum Odenwald
🇩🇪Erbach/Odenwald, Germany
Universitätsklinikum Erlangen, Neurologische Klinik
🇩🇪Erlangen, Germany
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
🇩🇪Freiburg, Germany
Neurologie & Psychiatrie Gladenbach - MS-Zentrum
🇩🇪Gladenbach, Germany
Neurologische Praxis Eppendorf
🇩🇪Hamburg, Germany
Neurologische Praxis
🇩🇪Hannover, Germany
Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie
🇩🇪Hennigsdorf, Germany
Praxis Dr. Hospely
🇩🇪Herford, Germany
Klinikum Ibbenbüren gmbH
🇩🇪Ibbenbüren, Germany
Universitätsklinikum Jena, Klinik für Neurologie
🇩🇪Jena, Germany
NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus
🇩🇪Köln, Germany
Neurologische Praxis Dr. Ehrlich
🇩🇪Leipzig, Germany
Neuroplus Dres. Lennart Thilmann/ Patrick Thilmann
🇩🇪Mannheim, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Praxis Dr. Leussink
🇩🇪Meerbusch, Germany
Neurologie am Preußenmuseum
🇩🇪Minden, Germany
Neurologie München Nord
🇩🇪München, Germany
Praxis für Neurologie und Psychiatrie am Prinzregentenplatz
🇩🇪München, Germany
Neurologisch-psychiatrische Praxis im A4
🇩🇪Neu - Ulm, Germany
Praxis Dr. med. Bergmann
🇩🇪Neuburg, Germany
Neurologie Nürnberg-Eibach
🇩🇪Nürnberg, Germany
Facharztpraxis für Neurologie und Psychiatrie Dres Mattes/Stockert
🇩🇪Pforzheim, Germany
Neurologisches Studienzentrum Artland
🇩🇪Quakenbrück, Germany
Praxis Dr. Stienker-Fisse
🇩🇪Remscheid, Germany
Neurologische Praxis Dr. Wagner
🇩🇪Schwetzingen, Germany
Praxis für Neurologie und Psychiatrie
🇩🇪Siegen, Germany
EMSA - Zentrum für Neurologie?/?Psychiatrie?/?Neuroradiologie
🇩🇪Singen, Germany
Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie
🇩🇪Stuttgart, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
🇩🇪Tübingen, Germany
Nervenfachaerztliche Gemeinschaftspraxis Ulm
🇩🇪Ulm, Germany
Neuropraxis München Süd
🇩🇪Unterhaching, Germany
Praxis für Neurologie, Psychiatrie und Epileptologie
🇩🇪Weil der Stadt, Germany
Praxis Dr. Michaela Krause
🇩🇪Wolfratshausen, Germany
Heinrich-Braun-Krankenhaus Städtisches Klinikum
🇩🇪Zwickau, Germany