CorEvitas Multiple Sclerosis (MS) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Primary outcome measures
- Number of patients with adverse events (AEs) or serious adverse events (SAEs). [Time frame: Time Frame: A minimum of 10 years from last patient enrolled]
Secondary outcome measures (8)
- Patient reported: Patient Clinical Global Impression (PCGI) Scale [Time frame: Time Frame: every 6 months for 10 years]
- Disease burden: Relapse Information [Time frame: Time Frame: every 6 months for 10 years]
- Percentage of patients with history of comorbidities [Time frame: Time Frame: at registry enrollment]
- Physician reported: Nine-Hole Peg Test (9-HPT) [Time frame: Time Frame: every 6 months for 10 years]
- Physician reported: Symbol Digit Modalities Test (SMDT) [Time frame: Time Frame: every 6 months for 10 years]
- Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI) [Time frame: Time Frame: every 6 months for 10 years]
- Patient reported: Patient reported :MS Quality of Life, MSIS-29 [Time frame: Time Frame: every 6 months for 10 years]
- Patient reported: MS Disability Score29 [Time frame: Time Frame: every 6 months for 10 years]
Eligibility criteria
Inclusion criteria
- Has a diagnosis of MS at the time of enrollment.
- Age 18 years or older at the time of enrollment.
- Willing to provide Personal Information.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- CorEvitas, LLC — Waltham
Identifiers
NCT: NCT03291756 · CorEvitas-MS-700