Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (MS-PEKOS)

September 15, 2025 updated by: Novartis Pharmaceuticals

Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (MS-PEKOS)

The study aims to compare the experiences, including injection-related reactions (IRRs) of patients newly receiving ofatumumab to those starting to receive ocrelizumab SC formulation

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with MS who are prescribed and initiating OMB or OCR SC and who are living in the US at the time of the survey will be invited to participate following a referral from their healthcare providers

Description

Inclusion Criteria:

  1. Ability to use a mobile device or computer with broadband internet access (or data streaming available)
  2. Ability to read, understand, and respond in English
  3. Adult aged 18 years of age or over at the time of the survey
  4. Self-confirmed diagnosis of MS
  5. Prescribed either OMB or OCR SC and will receive their first injection (Day 0) followed by completing the study survey between Day 1 and Day 7

Exclusion Criteria:

  1. Participated in an OMB or OCR randomized clinical trial
  2. Previously treated with OMB or OCR SC
  3. Cognitive impairment that impacts the patient's ability to participate in a survey study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ofatumumab
ocrelizumab SC formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients reported local injection-related reaction post first injection
Time Frame: Day 1- 7 post first injection, at the time of survey completion
Proportion of patients reported local injection-related reactions (including pain, erythema, induration, and pruritus) by using modified Defense and Veterans Pain Rating Scale (DVPRS)
Day 1- 7 post first injection, at the time of survey completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post first injection)
Time Frame: Day 1 - 7 post first injection, at the time of survey completion
Proportion of patients in a 5-Likert scale (extremely dissatisfied, dissatisfied, neutral, satisfied, and extremely satisfied) for satisfaction on injection-related experience
Day 1 - 7 post first injection, at the time of survey completion
Proportion of patients reported local injection-related reaction post second injection
Time Frame: Day 1- 7 post second injection, at the time of survey completion
Proportion of patients reported local injection-related reactions (including pain, erythema, induration, and pruritus) by using modified Defense and Veterans Pain Rating Scale (DVPRS)
Day 1- 7 post second injection, at the time of survey completion
Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post second injection)
Time Frame: Day 1- 7 post second injection, at the time of survey completion
Proportion of patients in a 5-Likert scale (extremely dissatisfied, dissatisfied, neutral, satisfied, and extremely satisfied) for satisfaction on injection-related experience
Day 1- 7 post second injection, at the time of survey completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Actual)

September 5, 2025

Study Completion (Actual)

September 5, 2025

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMB157AUS25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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