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

Tracking Information

First Received Date ^ICMJE

December 5, 2005

Last Updated Date

March 21, 2009

Start Date ^ICMJE

October 2000

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: Per Package Insert ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00262314 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Study Phase

Phase IV

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Multiple Sclerosis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

509

Completion Date

September 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00262314

Responsible Party

Jacqueline C. Beagan, RN, BSN, EMD Serono Inc.

Study ID Numbers ^ICMJE

24293, 19-297

Study Sponsor ^ICMJE

EMD Serono

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Randy Bennett, MD

EMD Serono Inc.

Information Provided By

EMD Serono

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP