- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04478591
The Wearing-off Phenomenon of Ocrelizumab in Patients With Multiple Sclerosis (WOC)
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North-Holland
-
Amsterdam, North-Holland, Netherlands, 1007 MB
- Amsterdam Umc, Location Vumc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with multiple sclerosis using ocrelizumab.
Patients with multiple sclerosis using ocrelizumab for a minimum of one year.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wearing-off symptoms
Time Frame: Baseline
|
Prevalence of wearing-off symptoms prior to ocrelizumab infusion (yes/no assessed on questionnaires)
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% 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.
|
At baseline (prior to next infusion with ocrelizumab)
|
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.
|
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)
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.
|
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).
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).
|
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)
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)
|
At baseline (prior to next infusion with ocrelizumab)
|
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
|
At baseline (prior to next infusion with ocrelizumab) and after two weeks
|
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
|
At baseline (prior to next infusion with ocrelizumab) and after two weeks
|
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).
|
Two weeks after ocrelizumab infusion
|
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).
|
Two weeks after ocrelizumab infusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joep Killestein, MD, PhD., Amsterdam Umc, Location Vumc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020.191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on Questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Sun Yat-sen UniversityNot yet recruiting
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
UNC Lineberger Comprehensive Cancer CenterCompletedBreast Cancer | MetastasisUnited States
-
M.D. Anderson Cancer CenterTerminatedSkin CancerUnited States