Corrona Multiple Sclerosis (MS) Registry
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|ClinicalTrials.gov Identifier: NCT03291756|
Recruitment Status : Enrolling by invitation
First Posted : September 25, 2017
Last Update Posted : December 6, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Corrona Multiple Sclerosis (MS) Registry|
|Actual Study Start Date :||August 10, 2017|
|Estimated Primary Completion Date :||December 2100|
|Estimated Study Completion Date :||December 2100|
Multiple Sclerosis Pts presenting to enrolling sites across the US are invited to enroll if eligible
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291756
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02451|
|Study Director:||Jeffrey Greenberg, MD||Corrona, LLC.|