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Completed

NCT Number: NCT04478591

The Wearing-off Phenomenon of Ocrelizumab in Patients With Multiple Sclerosis

The primary goal of this research is to study the prevalence of the wearing-off effect and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab with the use of questionnaires. Furthermore, the goal is to study whether patients receiving extended dosing of ocrelizumab experience more wearing-off symptoms or adverse events in general. Finally, we would like to extend knowledge on wearing-off symptoms in general.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Charcot-Marie-Tooth disease, Type 1F Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1007 MB, Netherlands

About this study

Ocrelizumab is a monoclonal antibody very effective for the treatment of relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis. Ocrelizumab is usually administered intravenous every six months. Natalizumab is another type of treatment used for relapsing-remitting multiple sclerosis and is administered every four weeks. Often patients report MS-related symptoms just prior to their next infusion such as fatigue, coordination problems or motor problems, the so-called wearing-off phenomenon. The exact etiology of this phenomenon remains unknown. Although not studied before, patients do report similar symptoms when using ocrelizumab. Furthermore, because of the COVID-19 pandemic, some patients receive extended dosing of ocrelizumab based on b-cell count. Whether this can increase wearing-off symptoms is unknown.

The goal of this research is to study the prevalence of wearing-off symptoms and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab. All patients using ocrelizumab during one year or more that provided written informed consent to participate in the study will be asked to complete three questionnaires before or during their next treatment with ocrelizumab. The questionnaires that will be used are the MSIS-29, the treatment satisfaction questionnaire and a questionnaire about wearing-off symptoms. Exact weight of the participants will be measured. Information about age, gender, date of diagnosis, start date of ocrelizumab, clinical and radiological disease activity, EDSS score, b-cell count and the biomarker neurofilament light will be extracted from the patient files. After two weeks, participants receive two additional digital questionnaires, the MSIS-29 and a follow-up questionnaire about wearing-off symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Diagnosis multiple sclerosis
  • Use of ocrelizumab as a treatment for multiple sclerosis for a minimum of one year

Exclusion criteria

  • Unable to answer questionnaires in Dutch
  • Different infusion protocol during the previous ocrelizumab infusion (e.g. 300 mg of ocrelizumab instead of 600 mg).

Treatment and study plan

questionnaires

Other

All participants will fill in two questionnaires before or during their next treatment with ocrelizumab: the MSIS-29 questionnaire and a wearing-off questionnaire. After two weeks, participants fill in two digital questionnaires (MSIS-29, additional wearing-off questionnaire).

Primary outcomes

  1. Wearing-off symptoms

    Time frame: Baseline

    Prevalence of wearing-off symptoms prior to ocrelizumab infusion (yes/no assessed on questionnaires)

Secondary outcomes

  1. % of wearing-off symptoms (yes/no assessed on questionnaires) in correlation to the % of patients with extended dosing versus standard dosing with ocrelizumab.

    Time frame: At baseline (prior to next infusion with ocrelizumab)

    % of wearing-off symptoms (yes/no assessed on questionnaires) in correlation to the % of patients with extended dosing versus standard dosing with ocrelizumab.

  2. Neurofilament light levels in patients with wearing-off symptoms.

    Time frame: At baseline (prior to next infusion with ocrelizumab)

    Neurofilament light levels in patients with wearing-off symptoms compared to patients without wearing-off symptoms.

  3. Absolute B-cells count in blood in correlation to the presence of wearing-off symptoms (yes/no assessed on questionnaires)

    Time frame: At baseline (prior to next infusion with ocrelizumab)

    Absolute B-cells count in blood in correlation to the presence of wearing-off symptoms (yes/no assessed on questionnaires) levels in patients with wearing-off symptoms.

  4. Type of multiple sclerosis (either RRMS or PPMS) in correlation to % of patients with wearing-off symptoms (yes/no assessed on questionnaires).

    Time frame: At baseline (prior to next infusion with ocrelizumab)

    Type of multiple sclerosis (either RRMS or PPMS) in correlation to % of patients with wearing-off symptoms (yes/no assessed on questionnaires).

  5. Treatment satisfaction score measured by the treatment satisfaction questionnaire in correlation to the % of patients with wearing-off symptoms (yes/no assessed on questionnaires)

    Time frame: At baseline (prior to next infusion with ocrelizumab)

    Treatment satisfaction score measured by the treatment satisfaction questionnaire in correlation to the % of patients with wearing-off symptoms (yes/no assessed on questionnaires)

  6. Self-reported disability (MSIS-29 questionnaire) compared before and after ocrelizumab infusion in patients with wearing-off symptoms

    Time frame: At baseline (prior to next infusion with ocrelizumab) and after two weeks

    Self-reported disability before ocrelizumab infusion compared before and after ocrelizumab (delta scores) in patients with wearing-off symptoms

  7. Self-reported disability (MSIS-29 questionnaire) after ocrelizumab infusion in patients without wearing-off symptoms

    Time frame: At baseline (prior to next infusion with ocrelizumab) and after two weeks

    Self-reported disability after ocrelizumab infusioSelf-reported disability before ocrelizumab infusion compared before and after ocrelizumab (delta scores) in patients with wearing-off symptomsn in patients without wearing-off symptoms

  8. Change of wearing-off symptoms after ocrelizumab infusion in patients with wearing-off symptoms

    Time frame: Two weeks after ocrelizumab infusion

    Change of wearing-off symptoms after ocrelizumab infusion in patients with wearing-off symptoms as measured with the wearing-off questionnaire (questionnaire designed for this study evaluating wearing-off symptoms).

  9. Post-dose symptoms after ocrelizumab infusion

    Time frame: Two weeks after ocrelizumab infusion

    Post-dose symptoms after ocrelizumab infusion as measured with the wearing-off questionnaire (questionnaire designed for this study evaluating wearing-off symptoms).

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Acronym: WOC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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