Risk Perception in Multiple Sclerosis

NCT05528666 | Completed

• 1 other identifier: COMB157G3001
• Study Type: observational
• Target: 4,361
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis (MS),; Disease-modifying therapies (DMTs),; High efficacy treatments (HETs),; Nonhigh efficacy treatments (Non-HETs)

Outcome Measures

Primary Outcomes (1)

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

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

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

Secondary Outcomes (11)

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

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

• Proportion of patients who switched due to lack of efficacy

  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

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

• Number of relapses

  Baseline

• Expanded Disability Status Scale (EDSS)

  Baseline

Study Arms (3)

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)

Previous HET

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

Other: High Efficacy Therapy (HET)

Interventions

High Efficacy Therapy (HET) OTHER

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

Previous HET

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.

Previous Non-HET

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

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

Location

Related Links

• Results for COMB157G3001 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 6, 2022
• Study Start: September 9, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 17, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)