Risk Perception in Multiple Sclerosis

NCT ID: NCT05528666

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4361 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-09

Study Completion Date

2021-09-17

Brief Summary

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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

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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).

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Overall cohort

Included all patients

No interventions assigned to this group

Previous Non-HET

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

Non High Efficacy Therapy (Non-HET)

Intervention Type OTHER

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

Previous HET

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

High Efficacy Therapy (HET)

Intervention Type OTHER

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

Interventions

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High Efficacy Therapy (HET)

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17971

Results for COMB157G3001 from the Novartis Clinical Trials Website

Other Identifiers

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COMB157G3001

Identifier Type: -

Identifier Source: org_study_id

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