Multiple SclerosisNCT03291756
CorEvitas Multiple Sclerosis (MS) Registry
An observational study of Multiple Sclerosis, run by CorEvitas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to Dec 2100
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are enrolled in the Multiple Sclerosis (MS) Registry during regularly -scheduled office visits. Selected neurologists are invited to participate as investigators in the Registry.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Multiple Sclerosis Pts presenting to enrolling sites across the US are invited to enroll if eligible |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events (AEs) or serious adverse events (SAEs).
Targeted events include malignancy, anaphylaxis, cardiovascular disease, serious infection, autoimmune disease, MS Relapse, hepatic events, and general serious adverse events.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Time Frame: A minimum of 10 years from last patient enrolled
Secondary outcomes (8)
Patient reported: Patient Clinical Global Impression (PCGI) Scale
Measured: Time Frame: every 6 months for 10 years
Disease burden: Relapse Information
Measured: Time Frame: every 6 months for 10 years
Percentage of patients with history of comorbidities
Measured: Time Frame: at registry enrollment
Physician reported: Nine-Hole Peg Test (9-HPT)
Measured: Time Frame: every 6 months for 10 years
Physician reported: Symbol Digit Modalities Test (SMDT)
Measured: Time Frame: every 6 months for 10 years
Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI)
Measured: Time Frame: every 6 months for 10 years
Patient reported: Patient reported :MS Quality of Life, MSIS-29
Measured: Time Frame: every 6 months for 10 years
Patient reported: MS Disability Score29
Measured: Time Frame: every 6 months for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start10 Aug 2017
- Primary completionDec 2100 (estimated)
- Study completionDec 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291756
- Sponsor's protocol ID
- CorEvitas-MS-700
- Status last verified
- Jan 2026
- First submitted
- 24 Aug 2017
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas Multiple Sclerosis (MS) Registry
- ClinicalTrials.gov ID
- NCT03291756
- Acronym / sponsor ID
- CorEvitas-MS-700
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- Dec 2100 (estimated)
- Study completion
- Dec 2100 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | –Multiple Sclerosis Pts presenting to enrolling sites across the US are invited to enroll if eligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are enrolled in the Multiple Sclerosis (MS) Registry during regularly -scheduled office visits. Selected neurologists are invited to participate as investigators in the Registry.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Targeted events include malignancy, anaphylaxis, cardiovascular disease, serious infection, autoimmune disease, MS Relapse, hepatic events, and general serious adverse events. An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- CorEvitas home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.