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Risk Perception in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT05528666
Recruitment Status : Completed
First Posted : September 6, 2022
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: High Efficacy Therapy (HET) Other: Non High Efficacy Therapy (Non-HET)

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).

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Study Type : Observational
Actual Enrollment : 4361 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Perception in Multiple Sclerosis
Actual Study Start Date : September 9, 2021
Actual Primary Completion Date : September 17, 2021
Actual Study Completion Date : September 17, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Overall cohort
Included all patients
Previous Non-HET
Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.
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.

Previous HET
HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.
Other: High Efficacy Therapy (HET)
HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05528666


Locations
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United States, New Jersey
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05528666    
Other Study ID Numbers: COMB157G3001
First Posted: September 6, 2022    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple sclerosis (MS),
Disease-modifying therapies (DMTs),
High efficacy treatments (HETs),
Nonhigh efficacy treatments (Non-HETs)
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases