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

Sponsor:	EMD Serono
Information provided by (Responsible Party):	EMD Serono
ClinicalTrials.gov Identifier:	NCT00262314

Purpose

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.

Condition	Phase
Multiple Sclerosis	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Heart Failure Multiple Sclerosis

Drug Information available for: Mitoxantrone Mitoxantrone hydrochloride

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Congestive Heart Failure (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
Number of patients experiencing congestive heart failure during the treatment phase of the trial
Congestive Heart Failure (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
Left Ventricular Ejection Fraction (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial
Left Ventricular Ejection Fraction (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
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) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
Number of serious infections during the treatment phase of the trial
Serious Infections (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
Number of serious infections during the annual follow-up phase of the trial
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
Severe Neutropenia (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
Number of infections associated with severe neutropenia at onset during the treatment phase
Severe Neutropenia (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
Number of infections associated with severe neutropenia at onset during the annual follow-up phase
Clinical Relapses (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
Number of clinical relapses reported during the treatment phase of the trial
Clinical Relapses (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
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 [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
Outcomes are presented separately above apart from adverse events which are presented in the adverse event section

Enrollment:	509
Study Start Date:	October 2000
Study Completion Date:	September 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262314

Locations

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

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Randy Bennett

EMD Serono Inc.

More Information

Additional Information:

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

No publications provided

Responsible Party:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00262314 History of Changes
Obsolete Identifiers:	NCT00016614
Other Study ID Numbers:	24293, 19-297
Study First Received:	December 5, 2005
Results First Received:	May 21, 2010
Last Updated:	August 23, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

Mitoxantrone
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2012