The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.
This phase IV, multicenter, prospective, open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available Novantrone®. The patients will be assessed every 3 months during treatment followed by annual assessment for a total of five (5) years. The select cohort of MS patients enrolled will have secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurological status is significantly abnormal between relapses). The overall objective of this study is to collect data relevant to the tolerability of Novantrone® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.
Study Type
OBSERVATIONAL
Enrollment
509
Registrat Inc
Lexington, Kentucky, United States
Congestive Heart Failure (Treatment Phase)
Number of patients experiencing congestive heart failure during the treatment phase of the trial
Time frame: up to 36 months
Congestive Heart Failure (Annual Follow-Up Phase)
Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
Time frame: up to 5 years
Left Ventricular Ejection Fraction (Treatment Phase)
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial
Time frame: up to 36 months
Left Ventricular Ejection Fraction (Annual Follow-Up Phase)
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial
Time frame: up to 5 years
Serious Infections (Treatment Phase)
Number of serious infections during the treatment phase of the trial
Time frame: up to 36 months
Serious Infections (Annual Follow-Up Phase)
Number of serious infections during the annual follow-up phase of the trial
Time frame: up to 5 years
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)
Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
Time frame: up to 36 months
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)
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Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
Time frame: up to 5 years
Severe Neutropenia (Treatment Phase)
Number of infections associated with severe neutropenia at onset during the treatment phase
Time frame: up to 36 months
Severe Neutropenia (Annual Follow-Up Phase)
Number of infections associated with severe neutropenia at onset during the annual follow-up phase
Time frame: up to 5 years
Clinical Relapses (Treatment Phase)
Number of clinical relapses reported during the treatment phase of the trial
Time frame: up to 36 months
Clinical Relapses (Annual Follow-Up Phase)
Number of clinical relapses reported during the annual follow-up phase of the trial
Time frame: up to 5 years
Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose • Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI • SAE, Clinical Relapses
Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
Time frame: up to 5 years