Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation

NCT06668324 | Completed

• 1 other identifier: COMB157AUS25
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reported local injection-related reaction post first injection

  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 Outcomes (3)

• Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post first injection)

  Day 1 - 7 post first injection, at the time of survey completion

• Proportion of patients reported local injection-related reaction post second injection

  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)

  Day 1- 7 post second injection, at the time of survey completion

Study Arms (2)

ofatumumab

ocrelizumab SC formulation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative site

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 31, 2024
• Study Start: November 15, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)