WOE of Anti-CD20 Therapies

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

Conditions

Multiple Sclerosis

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Study Overview

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Study Details

Study overview

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

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

WOE of Anti-CD20 Therapies

Condition
Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

East Hanover

Novartis Investigational site, East Hanover, New Jersey, United States, 07936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * Currently participating in a clinical trial involving MS drugs
  • * Last Ocrevus infusion was less than 3 months back

Ages Eligible for Study

21 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2025-02-03