Risk Perception in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Non High Efficacy Therapy (Non-HET); Other: High Efficacy Therapy (HET)

• Registration Number: NCT05528666
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs). HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.

Detailed Description

The study cohort consisted of RMS patients identified in the Adelphi Real World MS DSP, which was current up until the Q2/2021. The study was using waves VI-IX of the Adelphi DSP dataset.

Study period: Q1 2017 - Q1 \& Q2 2021 (waves VI-IX of Adelphi DSP dataset).

Identification period: Q1 2017 - Q1 \& Q2 2021 (waves VI-IX of Adelphi DSP dataset).

Index date: defined as the dates when the surveys were carried out (Q1 2017 - Q1 \& Q2 2021).

Study Timeline

• Study Start: 2021-09-09
• Primary Completion: 2021-09-17
• Study Completion: 2021-09-17
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4361

Inclusion Criteria

• Patients included in the database with a diagnosis of RRMS and SPMS.
• Patients with current treatment at the index date.
• Patients with previous treatment at the index date.
• Patients to whom the physician decided to switch the treatment from the previous treatment to current treatment at the index date.
• Patients (males & females) with 18 years or older at index date.

Exclusion Criteria

• Patients included in the database with the diagnosis of primary progressive MS (PPMS).
• Patients with other major neurological or psychiatric condition, which could potentially hinder the analysis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Previous Non-HET	Non High Efficacy Therapy (Non-HET)	Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.
Previous HET	High Efficacy Therapy (HET)	HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who were switched based on risk perception (infections, malignancies, others)	Throughout the study, approximately 5 years (2017 to 2021)	Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported.

Secondary Outcome Measures

Name	Time	Method
Age	Baseline	Age information reported
Number of patients with Initial MS diagnosis	Baseline	Number of patients with Initial MS diagnosis were reported.
Number of patients with previous disease modifying treatment	Baseline	Number of patients with previous disease modifying treatment were reported.
Number of patients with ranking of the frequency of switches due to risk perception	Throughout the study, approximately 5 years (2017 to 2021)	Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported.
Proportion of patients who switched due to lack of efficacy	Throughout the study, approximately 5 years (2017 to 2021)	Proportion of patients who switched due to lack of efficacy due to new or enlarging lesions on MRI, increase in the frequency and/or severity of the relapses, progression in physical disability measured by EDSS or patient compliance issues between groups were reported.
Expanded Disability Status Scale (EDSS)	Baseline	The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Number of patients: Employment status	Baseline	Patient employment status reported
Number of relapses	Baseline	Number of relapses were reported.
Proportion of patients who changed treatment group versus patients who continued in the same treatment group	Throughout the study, approximately 5 years (2017 to 2021)	Proportion of patients who changed treatment group versus patients who continued in the same treatment group were reported.
Gender	Baseline	Gender information reported
Number of patients with Current MS diagnosis	Baseline	Number of patients with Current MS diagnosis were reported.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 East Hanover, New Jersey, United States