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

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis

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.

• Study Type: Observational
• Enrollment (Actual): 509

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40504-3276
      • Registrat Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with a clinically definite or laboratory supported diagnosis of MS and having secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurologic status is significantly abnormal between relapses). Patients with primary progressive disease will not be included in this study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Congestive Heart Failure (Treatment Phase)	Number of patients experiencing congestive heart failure during the treatment phase of the trial	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	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	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	up to 5 years
Serious Infections (Treatment Phase)	Number of serious infections during the treatment phase of the trial	up to 36 months
Serious Infections (Annual Follow-Up Phase)	Number of serious infections during the annual follow-up phase of the trial	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	up to 36 months
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)	Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase	up to 5 years
Severe Neutropenia (Treatment Phase)	Number of infections associated with severe neutropenia at onset during the treatment phase	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	up to 5 years
Clinical Relapses (Treatment Phase)	Number of clinical relapses reported during the treatment phase of the trial	up to 36 months
Clinical Relapses (Annual Follow-Up Phase)	Number of clinical relapses reported during the annual follow-up phase of the trial	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	up to 5 years

Collaborators and Investigators

• Sponsor: EMD Serono
• Investigators: Study Director: Randy Bennett, EMD Serono

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: December 5, 2005
• First Submitted That Met QC Criteria: December 5, 2005
• First Posted (Estimate): December 6, 2005

Study Record Updates

• Last Update Posted (Estimate): November 14, 2013
• Last Update Submitted That Met QC Criteria: October 21, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 24293; 19-297