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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00262314
First Posted: December 6, 2005
Last Update Posted: November 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
EMD Serono
December 5, 2005
December 6, 2005
May 21, 2010
June 23, 2010
November 14, 2013
October 2000
January 2008   (Final data collection date for primary outcome measure)
  • Congestive Heart Failure (Treatment Phase) [ Time Frame: up to 36 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    Number of serious infections during the treatment phase of the trial
  • Serious Infections (Annual Follow-Up Phase) [ Time Frame: up to 5 years ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Number of clinical relapses reported during the treatment phase of the trial
  • Clinical Relapses (Annual Follow-Up Phase) [ Time Frame: up to 5 years ]
    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 ]
    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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00262314
24293
19-297
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EMD Serono
EMD Serono
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Study Director: Randy Bennett EMD Serono
EMD Serono
October 2013