WOE of Anti-CD20 Therapies

Novartis

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Drug: ocrelizumab; Drug: ofatumumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06121349

COMB157AUS22

Details and patient eligibility

About

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

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

OCR

Description:

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

Treatment:

Drug: ocrelizumab

OMB

Description:

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

Treatment:

Drug: ofatumumab