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OpenTrials
Completed

NCT Number: NCT05528666

Risk Perception in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Efficacy Therapy (HET)

Other

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

Non High Efficacy Therapy (Non-HET)

Other

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

Primary outcomes

  1. Proportion of patients who were switched based on risk perception (infections, malignancies, others)

    Time frame: 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 outcomes

  1. Number of patients with ranking of the frequency of switches due to risk perception

    Time frame: Throughout the study, approximately 5 years (2017 to 2021)

    Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported.

  2. Proportion of patients who switched due to lack of efficacy

    Time frame: 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.

  3. Proportion of patients who changed treatment group versus patients who continued in the same treatment group

    Time frame: 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.

  4. Number of relapses

    Time frame: Baseline

    Number of relapses were reported.

  5. Expanded Disability Status Scale (EDSS)

    Time frame: 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.

  6. Age

    Time frame: Baseline

    Age information reported

  7. Gender

    Time frame: Baseline

    Gender information reported

  8. Number of patients: Employment status

    Time frame: Baseline

    Patient employment status reported

  9. Number of patients with Initial MS diagnosis

    Time frame: Baseline

    Number of patients with Initial MS diagnosis were reported.

  10. Number of patients with Current MS diagnosis

    Time frame: Baseline

    Number of patients with Current MS diagnosis were reported.

  11. Number of patients with previous disease modifying treatment

    Time frame: Baseline

    Number of patients with previous disease modifying treatment were reported.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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