Clinical trial NCT05528666: Risk Perception in Multiple Sclerosis
Official title: Risk Perception in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis (MS),
Disease-modifying therapies (DMTs),
High efficacy treatments (HETs),
Nonhigh efficacy treatments (Non-HETs)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-09-06
Enrollment: 4361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study cohort consisted of RRMS and SPMS patients identified in the Adelphi Real World MS Disease Specific Program (DSP) (2017-2021) with a current and previous treatment at index date, and whose physician decided to switch their treatment.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who were switched based on risk perception (infections, malignancies, others)
timeFrame: Throughout the study, approximately 5 years (2017 to 2021)
Secondary outcomes:
measure: Number of patients with ranking of the frequency of switches due to risk perception
timeFrame: Throughout the study, approximately 5 years (2017 to 2021)
measure: Proportion of patients who switched due to lack of efficacy
timeFrame: Throughout the study, approximately 5 years (2017 to 2021)
measure: Proportion of patients who changed treatment group versus patients who continued in the same treatment group
timeFrame: Throughout the study, approximately 5 years (2017 to 2021)
measure: Number of relapses
timeFrame: Baseline
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Number of patients: Employment status
timeFrame: Baseline
measure: Number of patients with Initial MS diagnosis
timeFrame: Baseline
measure: Number of patients with Current MS diagnosis
timeFrame: Baseline
measure: Number of patients with previous disease modifying treatment
timeFrame: Baseline
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: