WOE of Anti-CD20 Therapies

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06121349
Study type	Observational
Source	Novartis
Contact	Novartis Pharmaceuticals
Phone	+41613241111
Email	novartis.email@novartis.com
Status	Recruiting
Phase
Start date	December 4, 2023
Completion date	February 3, 2025

View Details

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