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

Hoffmann-La Roche842 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

842

Conditions

Multiple Sclerosis

Interventions

OcrelizumabDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 women

Locations (72)

Outcomes

Primary Outcomes

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.

Time frame: Month 12

Secondary Outcomes

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

Change From Baseline in NfL Protein Levels in Serum

Time frame: Month 6, Month 12

Concentration of NfL Protein Levels in Serum

Time frame: Baseline, Month 6, Month 12

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.

Time frame: Up to Month 12

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.

Central Contacts

Reference Study ID Number: ML45551 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Uniklinik RWTH Aachen

Aachen, Germany

RECRUITING

Neuropraxis im Stadtpalais Dres. Ulzheimer/Herröder/Wessig GbR

Aschaffenburg, Germany

RECRUITING

Neurologie Bad Soden

Bad Soden, Germany

RECRUITING

Neurologische Praxis - Kallmann Neurologie - mszb

Bamberg, Germany

RECRUITING

Neurologisches Facharztzentrum Berlin am Sankt Gertrauden-Krankenhaus

Berlin, Germany

RECRUITING

NEUROZENTRUM tempelhof.berlin

Berlin, Germany

RECRUITING

Praxis Dr. Said Masri

Berlin, Germany

RECRUITING

Jüdisches Krankenhaus Berlin

Berlin, Germany

RECRUITING

NeuroZentrum Zehlendorf Dr. Ringel und Dr. Scherer

Berlin, Germany

RECRUITING

Neurologisches Zentrum für Bewegungsstörungen und Diagnostik

Berlin, Germany

RECRUITING

...and 62 more locations

Time frame: Up to Month 12

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.

Time frame: Up to Month 12

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.

Time frame: Up to Month 12

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.

Time frame: Up to Month 12

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.

Time frame: Up to Month 12

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.

Time frame: Up to Month 12

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.

Time frame: Up to Month 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.

Time frame: Up to Month 12

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.

Time frame: Up to Month 12

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.

Time frame: Month 6, Month 12

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

Time frame: Baseline, Month 6, Month 12

Annualized Relapse Rate

Time frame: Month 12

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

Time frame: 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