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

Merck KGaA (EMD Serono) logo

Merck KGaA (EMD Serono)

Status

Completed

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Industry

Identifiers

NCT00262314
19-297
24293

Details and patient eligibility

About

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.

Full 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.

Enrollment

509 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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