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

NCT04478591 | Completed

• 1 other identifier: 2020.191
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Ocrelizumab; Wearing-off effect; Neurofilament Light; Extended dosing

Outcome Measures

Primary Outcomes (1)

• Wearing-off symptoms

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

  Baseline

Secondary Outcomes (9)

• % 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.

  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)

  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)

  At baseline (prior to next infusion with ocrelizumab)

Study Arms (1)

Patients with multiple sclerosis using ocrelizumab.

Patients with multiple sclerosis using ocrelizumab for a minimum of one year.

Other: Questionnaires

Interventions

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).

Patients with multiple sclerosis using ocrelizumab.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple sclerosis using ocrelizumab.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1007 MB, Netherlands

Location

MeSH Terms

Conditions

Multiple Sclerosis; Charcot-Marie-Tooth disease, Type 1F

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Joep Killestein, MD, PhD.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 20, 2020
• Study Start: May 12, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

NL (1)