Last Update: Jan 29, 2024
The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis
ClinicalTrials.gov Identifier:
Novartis Reference Number:COMB157AUS22
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study 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 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

Multiple Sclerosis
Recruiting
150
Dec 04, 2023
Feb 03, 2025
All
21 Years - 85 Years (Adult, Older Adult)

Interventions

Drug

ocrelizumab

infusion therapy administered every six months
Drug

ofatumumab

self-injectable every month

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

Worldwide Contacts

If the location of your choosing does not feature any contact detail, please reach out using the information below.

Novartis Pharmaceuticals