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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
Sponsor:
Information provided by (Responsible Party):
Corrona, LLC.

Brief 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. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Condition or disease
Multiple Sclerosis

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Patient reported: Patient Clinical Global Impression (PCGI) Scale [ Time Frame: Time Frame: every 6 months for 10 years ]
  2. Disease burden: Relapse Information [ Time Frame: Time Frame: every 6 months for 10 years ]
  3. Percentage of patients with history of comorbidities [ Time Frame: Time Frame: at registry enrollment ]
  4. Physician reported: Nine-Hole Peg Test (9-HPT) [ Time Frame: Time Frame: every 6 months for 10 years ]
  5. Physician reported: Symbol Digit Modalities Test (SMDT) [ Time Frame: Time Frame: every 6 months for 10 years ]
  6. Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI) [ Time Frame: Time Frame: every 6 months for 10 years ]
  7. Patient reported: Patient reported :MS Quality of Life, MSIS-29 [ Time Frame: Time Frame: every 6 months for 10 years ]
  8. Patient reported: MS Disability Score29 [ Time Frame: Time Frame: every 6 months for 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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).


Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Corrona, LLC
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Corrona, LLC.
Investigators
Study Director: Jeffrey Greenberg, MD Corrona, LLC.

Additional Information:
Responsible Party: Corrona, LLC.
ClinicalTrials.gov Identifier: NCT03291756     History of Changes
Other Study ID Numbers: Corrona-MS-700
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases