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

Multiple Sclerosis Clinical Trial

— RENEW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262314
• Other study ID #: 24293
• Secondary ID: 19-297
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2005
• Last updated: October 21, 2013
• Start date: October 2000
• Est. completion date: September 2008

Study information

• Verified date: October 2013
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00016614

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: September 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Registrat Inc	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Congestive Heart Failure (Treatment Phase)	Number of patients experiencing congestive heart failure during the treatment phase of the trial	up to 36 months	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Serious Infections (Treatment Phase)	Number of serious infections during the treatment phase of the trial	up to 36 months	Yes
Primary	Serious Infections (Annual Follow-Up Phase)	Number of serious infections during the annual follow-up phase of the trial	up to 5 years	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Severe Neutropenia (Treatment Phase)	Number of infections associated with severe neutropenia at onset during the treatment phase	up to 36 months	Yes
Primary	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	Yes
Primary	Clinical Relapses (Treatment Phase)	Number of clinical relapses reported during the treatment phase of the trial	up to 36 months	No
Primary	Clinical Relapses (Annual Follow-Up Phase)	Number of clinical relapses reported during the annual follow-up phase of the trial	up to 5 years	No
Primary	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	Yes