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

NCT05301907 | Completed

• 2 other identifiers: CBAF312A2006EUPAS44782
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MS; NIS; survey

Outcome Measures

Primary Outcomes (3)

• Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.

  Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials to be collected

  Throughout study completion, an average of 3 years

• Knowledge and understanding of the HCPs as per detailed in the educational information provided

  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 was measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.

  Throughout study completion, an average of 3 years

• Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided

  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 was measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.

  Throughout study completion, an average of 3 years

Study Arms (2)

Health Care Professionals (HCPs)

HCPs who prescribe, monitor and oversee the management / or provide in person medical supervision of patients on Mayzent (siponimod).

Patients/Caregivers

Patients/Caregivers of patients who are taking Mayzent (siponimod) to treat their MS and according to the prescription of their neurologists across EU countries and Canada that were included in the launch program

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HCPs who prescribe, monitor and oversee the management / or provide in person medical supervision of patients on Mayzent (siponimod). And Patients/Caregivers of patients who are taking Mayzent (siponimod) to treat their MS and according to the prescription of their neurologists in selected EU countries

You may qualify if:

• Physicians were 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 were 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.
• \- Had initiated onto Mayzent (siponimod) to treat their MS since reimbursement

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Basel, Switzerland

Location

Related Links

• Link to study results

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 Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: December 2, 2021
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)