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Sponsor: Novartis Pharmaceuticals
Conditions: Multiple Sclerosis
Interventions: ocrelizumab, ofatumumab
Countries: United States
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
Sex: ALL
Age: 21 Years to 85 Years
Healthy volunteers: No
Study type: OBSERVATIONAL
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
- East Hanover, New Jersey, United States