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CorEvitas Multiple Sclerosis (MS) Registry

NCT ID: NCT03291756

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-10

Study Completion Date

2100-12-31

Brief Summary

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This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for MS in a cohort of patients cared for by neurologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Detailed Description

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The objective of the CorEvitas Multiple Sclerosis (MS) Registry is to create a national cohort of patients with MS. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of MS. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the prevalence and incidence of comorbidities and adverse events, medication utilization patterns and patient productivity measures.

The design is a prospective, non-interventional, observational registry for patients with MS under the care of a licensed neurologist. Longitudinal follow-up data is collected from both patients and their treating neurologist (also known as "Providers" for a CorEvitas registry study) every 6 months (+/- 30 days) during routine clinical encounters using CorEvitas registry forms. These forms collect data on patient demographics, disease duration, medical history (including all prior and current treatments for MS), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes. After the enrollment visit, MS patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals. Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Sclerosis

Multiple Sclerosis Pts presenting to enrolling sites across the US are invited to enroll if eligible

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Has a diagnosis of MS at the time of enrollment.
2. Age 18 years or older at the time of enrollment.
3. Willing to provide Personal Information.
4. Initiating (prescribed or starting) an Eligible Medication for the treatment of MS at the enrollment visit.

Exclusion Criteria

1\) Is participating or planning to participate in a double-blind randomized trial for an MS drug. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CorEvitas

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CorEvitas, LLC

Waltham, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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https://www.corevitas.com/

CorEvitas home page

Other Identifiers

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CorEvitas-MS-700

Identifier Type: -

Identifier Source: org_study_id