Study Description
The nature, intensity, and prevalence of this wearing-off effect remain poorly understood. To our knowledge, there is no consensus in the literature on what symptoms constitute a wearing-off effect, nor is there a single validated scale that measures wearing-off effect. The current study will explore the wearing-off effect associated with OCR and OMB, using a variety of validated scales assessing MS symptoms (i.e., fatigue, mobility, pain, depression, cognition), as well as some global questions on wearing-off. In addition, impact of worsening of MS symptoms on patients' health-related quality of life (HRQoL) and their work productivity will be assessed using relevant MS-specific validated scales
This will be a non-interventional, primary data collection study in patients with MS treated with an established anti-CD20 treatment regimen (OCR or OMB) in the United States. Patients who satisfy the inclusion criteria and consent to participate in the study will be surveyed at four timepoints at the beginning and the end of OCR or OMB treatment cycles according to the following assessment schedule:
Assessment 1. 0-10 days before 1st dose post-enrollment (index dose)
Assessment 2: 5-14 days after index dose
Assessment 3: 0-10 days before 2nd dose post-enrollment (follow-up dose)
Assessment 4: 5-14 days after follow-up dose dose
Interventions
ocrelizumab
ofatumumab
Eligibility Criteria
Inclusion Criteria:
OCR sample:
Self-reported diagnosis of RMS, SPMS or CIS
≥21 years old at the time of initial contact
Under treatment with OCR at the time of initial contact
Have been on OCR for ≥ 1 year at the time of initial contact (i.e., prevalent users)
Able to answer the questionnaires in English
OMB sample
Self-reported diagnosis of RMS, SPMS or CIS
≥21 years old at the time of initial contact
Under treatment with OMB at the time of initial contact
Have been on OMB for ≥6 months at the time of initial contact (i.e., prevalent users)
Able to answer the questionnaires in English
Exclusion Criteria:
OCR sample:
Currently participating in a clinical trial involving MS drugs
Last Ocrevus infusion was less than 3 months back
OMB sample:
Currently participating in a clinical trial involving MS drugs
Study Location
Novartis Investigational site
Recruiting
East Hanover,New Jersey,07936,United States
Worldwide Contacts
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