Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

Completed

Conditions: Multiple Sclerosis

Registration Number: NCT00262314

Lead Sponsor: EMD Serono

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 509

Inclusion Criteria

To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria:
Platelet count >100,000 cells/µL
Granulocyte count > 2000 cells/µL
Age 18-65 years
Negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control
For patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of Novantrone®
Signed Inform Consent.

Exclusion Criteria

To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
Presence of cardiac risk factors:
History of congestive heart failure
LVEF < 50% determined by echocardiography or MUGA
Previous treatment with Novantrone®, other anthracenediones, or anthracyclines
Prior mediastinal radiotherapy or total lymphoidal irradiation
AST, ALT, bilirubin > 2x upper limits of normal
Severe untreated infection (including current urinary tract infection)
Nursing or pregnant women)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Congestive Heart Failure (Annual Follow-Up Phase)	up to 5 years	Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
Left Ventricular Ejection Fraction (Annual Follow-Up Phase)	up to 5 years	Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial
Serious Infections (Treatment Phase)	up to 36 months	Number of serious infections during the treatment phase of the trial
Congestive Heart Failure (Treatment Phase)	up to 36 months	Number of patients experiencing congestive heart failure during the treatment phase of the trial
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)	up to 36 months	Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
Left Ventricular Ejection Fraction (Treatment Phase)	up to 36 months	Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)	up to 5 years	Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
Severe Neutropenia (Annual Follow-Up Phase)	up to 5 years	Number of infections associated with severe neutropenia at onset during the annual follow-up phase
Clinical Relapses (Treatment Phase)	up to 36 months	Number of clinical relapses reported during the treatment phase of the trial
Clinical Relapses (Annual Follow-Up Phase)	up to 5 years	Number of clinical relapses reported during the annual follow-up phase of the trial
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	up to 5 years	Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
Serious Infections (Annual Follow-Up Phase)	up to 5 years	Number of serious infections during the annual follow-up phase of the trial
Severe Neutropenia (Treatment Phase)	up to 36 months	Number of infections associated with severe neutropenia at onset during the treatment phase