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OpenTrials
Completed

NCT Number: NCT00262314

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Registrat Inc

Lexington, Kentucky, 40504-3276, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. Serious Infections (Treatment Phase)

    Time frame: up to 36 months

    Number of serious infections during the treatment phase of the trial

  6. 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

  7. 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

  8. 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

  9. Severe Neutropenia (Treatment Phase)

    Time frame: up to 36 months

    Number of infections associated with severe neutropenia at onset during the treatment phase

  10. 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

  11. Clinical Relapses (Treatment Phase)

    Time frame: up to 36 months

    Number of clinical relapses reported during the treatment phase of the trial

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Acronym: RENEW

Important dates

Study start
2000
Primary completion
2008
Study completion
2008
First posted
Dec 6, 2005
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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