Survey Among Healthcare Professionals and MS Patients to Assess Their Understanding of RMP Materials

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT05301907
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Survey to be completed independently by HCPs (neurologists treating patients with MS and MS specialist nurses) and patients/caregivers.

Detailed Description

The survey- based study is conducting amongst HCPs and patients/caregivers in selected European countries including Germany, Netherlands, Nordics (Denmark, Sweden), Spain and Croatia, plus Canada, to evaluate whether HCPs and patients/caregivers receive the educational materials and to capture their knowledge of specific Mayzent (siponimod) safety measures.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2021-12-02
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

Physicians will be considered eligible for the survey if they meet the following screening criteria:

• Care for relapsing MS (RMS) patients
• Personally prescribed disease modifying therapies to MS patients, and;
• Have prescribed Mayzent (siponimod) in at least 1 SPMS patient.

Nurses will be considered eligible for the survey if they:

• Provide supportive care for RMS patients
• Have initiated and/or managed the use of Mayzent (siponimod) in at least 1 SPMS patient.

Patient inclusion criteria include:

• Have been initiated onto Mayzent (siponimod) to treat their MS since reimbursement

Read More

Exclusion Criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.	Throughout study completion, an average of 3 years	Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials to be collected
Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided	Throughout study completion, an average of 3 years	Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided relating to: * Specific safety measures when being treated with Mayzent (siponimod); * Side effects and potential risks; Knowledge and understanding will be measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.
Knowledge and understanding of the HCPs as per detailed in the educational information provided	Throughout study completion, an average of 3 years	Knowledge and understanding of the HCPs as per detailed in the educational information provided relating to: * The appropriate initiation; * Specific safety measures when treating patients with Mayzent (siponimod); * Steps when treating patients with sinus bradycardia, 1st/2nd degree AV block or history of myocardial infarction or health failure; * Procedures for the management of infections, macular edema, skin malignancies and pregnancy considerations.; * Steps in ophthalmology checklist, managing infection risk, pregnancy, liver function and skin examinations; Knowledge and understanding will be measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇭 Basel, Switzerland