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

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

This study is ongoing, but not recruiting participants.
Information provided by EMD Serono

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Observational

Study Design ^†

Cohort, Prospective

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Condition ^†

Multiple Sclerosis

Intervention ^†

MEDLINE PMIDs

Links

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

509

Start Date ^†

October 2000

Completion Date

March 2008

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00262314

Organization ID

24293

Secondary IDs ^††

19-297

Study Sponsor ^†

EMD Serono

Collaborators ^††

Investigators ^†

Study Director:

Randy Bennett, MD

EMD Serono Inc.

Information Provided By

EMD Serono

Verification Date

March 2008

First Received Date ^†

December 5, 2005

Last Updated Date

March 13, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.