NCT06121349

WOE of Anti-CD20 Therapies

The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 157 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	ocrelizumab	infusion therapy administered every six months
DRUG	ofatumumab	self-injectable every month

Timeline

• Start date: 2023-12-04
• Primary completion: 2025-06-13
• Completion: 2025-06-13
• First posted: 2023-11-07
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States