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OpenTrials
Completed

NCT Number: NCT06668324

Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative site

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to use a mobile device or computer with broadband internet access (or data streaming available)
  • Ability to read, understand, and respond in English
  • Adult aged 18 years of age or over at the time of the survey
  • Self-confirmed diagnosis of MS
  • 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

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: MS-PEKOS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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