Risk Perception in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Risk Perception in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05528666
• Other study ID #: COMB157G3001
• Status: Completed
• Start date: September 9, 2021
• Est. completion date: September 17, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4361
• Est. completion date: September 17, 2021
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with ranking of the frequency of switches due to risk perception	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	Proportion of patients who switched due to lack of efficacy	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.	Throughout the study, approximately 5 years (2017 to 2021)
Secondary	Proportion of patients who changed treatment group versus patients who continued in the same treatment group	Proportion of patients who changed treatment group versus patients who continued in the same treatment group were reported.	Throughout the study, approximately 5 years (2017 to 2021)
Secondary	Number of relapses	Number of relapses were reported.	Baseline
Secondary	Expanded Disability Status Scale (EDSS)	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.	Baseline
Secondary	Age	Age information reported	Baseline
Secondary	Gender	Gender information reported	Baseline
Secondary	Number of patients: Employment status	Patient employment status reported	Baseline
Secondary	Number of patients with Initial MS diagnosis	Number of patients with Initial MS diagnosis were reported.	Baseline
Secondary	Number of patients with Current MS diagnosis	Number of patients with Current MS diagnosis were reported.	Baseline
Secondary	Number of patients with previous disease modifying treatment	Number of patients with previous disease modifying treatment were reported.	Baseline

External Links

•   Results for COMB157G3001 from the Novartis Clinical Trials Website