COMPLETED

WOE of Anti-CD20 Therapies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-12-04
Study Completion:2025-06-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06121349

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.

Ages Eligible for Study:21 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-reported diagnosis of RMS, SPMS or CIS
  2. * ≥21 years old at the time of initial contact
  3. * Under treatment with OCR at the time of initial contact
  4. * Have been on OCR for ≥ 1 year at the time of initial contact (i.e., prevalent users)
  5. * Able to answer the questionnaires in English
  6. * Self-reported diagnosis of RMS, SPMS or CIS
  7. * ≥21 years old at the time of initial contact
  8. * Under treatment with OMB at the time of initial contact
  9. * Have been on OMB for ≥6 months at the time of initial contact (i.e., prevalent users)
  10. * Able to answer the questionnaires in English
  1. * Currently participating in a clinical trial involving MS drugs
  2. * Last Ocrevus infusion was less than 3 months back

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

Novartis Investigative Site
East Hanover, New Jersey, 07936
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04
Study Completion Date2025-06-13

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2025-06-13

Terms related to this study

Keywords Provided by Researchers

  • NIS
  • Anti-CD20 Therapies
  • Multiple Sclerosis
  • OCR
  • Ocrevus
  • OMB
  • KESIMPTA

Additional Relevant MeSH Terms

  • Multiple Sclerosis