Corrona Multiple Sclerosis (MS) Registry
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2018 |
| Start Date: | August 10, 2017 |
| End Date: | December 2100 |
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.
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.
The objective of the Corrona 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 Corrona registry
study) every 6 months (+/- 30 days) during routine clinical encounters using Corrona registry
questionnaires. These questionnaires 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 Corrona related visits with the Investigator, subjects will
be questioned regarding the occurrence of adverse events.
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 Corrona registry
study) every 6 months (+/- 30 days) during routine clinical encounters using Corrona registry
questionnaires. These questionnaires 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 Corrona related visits with the Investigator, subjects will
be questioned regarding the occurrence of adverse events.
Inclusion Criteria:
- At least 18 years of age or older.
- Willing and able to provide written consent for participation in the MS Registry.
- Willing and able to provide Personally Identifiable Information (PII) which includes
the following types of personal information at a minimum: full name, date of birth,
sex, and home address zip code.
- Diagnosis of multiple sclerosis (MS)
Exclusion Criteria:
• Participating in or planning to participate in a clinical trial with a non-marketed or
marketed investigational drug (i.e. phase I-IV drug trial).
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