WOE of Anti-CD20 Therapies

NCT ID: NCT06121349

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 157 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2025-06-13

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

OCR

Patients under treatment with Ocrelizumab (OCR) for at least 1 year prior to study start.

ocrelizumab

Intervention Type: DRUG

infusion therapy administered every six months

OMB

Patients under treatment with ofatumumab (OMB) for at least 6 months prior to study start

ofatumumab

Intervention Type: DRUG

self-injectable every month

Interventions

ocrelizumab

infusion therapy administered every six months

Intervention Type: DRUG

ofatumumab

self-injectable every month

Intervention Type: DRUG

Other Intervention Names

Ocrevus; KESIMPTA

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

COMB157AUS22

Identifier Type: -

Identifier Source: org_study_id