Risk Perception in Multiple Sclerosis

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: High Efficacy Therapy (HET); Other: Non High Efficacy Therapy (Non-HET)

Study type: Observational

Funder types: Industry

Identifiers

NCT05528666

COMB157G3001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4,361 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

4,361 participants in 3 patient groups

Overall cohort

Description:

Included all patients

Previous Non-HET

Description:

Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.

Treatment:

Other: Non High Efficacy Therapy (Non-HET)

Previous HET

Description:

HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.

Treatment:

Other: High Efficacy Therapy (HET)