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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00262314
First received: December 5, 2005
Last updated: October 21, 2013
Last verified: October 2013

December 5, 2005
October 21, 2013
October 2000
January 2008   (final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT00262314 on ClinicalTrials.gov Archive Site
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Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Multiple Sclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
509
September 2008
January 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00262314
24293, 19-297
Not Provided
EMD Serono
EMD Serono
Not Provided
Study Director: Randy Bennett EMD Serono, Inc.
EMD Serono
October 2013

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