Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation

Not yet recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06668324
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-22
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Study Start: 2025-01-13
• Primary Completion: 2025-01-27
• Study Completion: 2025-01-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients reported local injection-related reaction post first injection	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 Outcome Measures

Name	Time	Method
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 in a 5-Likert scale (extremely dissatisfied, dissatisfied, neutral, satisfied, and extremely satisfied) for satisfaction on injection-related experience
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 reported local injection-related reactions (including pain, erythema, induration, and pruritus) by using modified Defense and Veterans Pain Rating Scale (DVPRS)
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	Proportion of patients in a 5-Likert scale (extremely dissatisfied, dissatisfied, neutral, satisfied, and extremely satisfied) for satisfaction on injection-related experience