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

Information source: EMD Serono
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Phase: Phase 4

Status: Completed

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Randy Bennett, Study Director, Affiliation: EMD Serono

Summary

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.

Clinical Details

Official title: Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Congestive Heart Failure (Treatment Phase)

Congestive Heart Failure (Annual Follow-Up Phase)

Left Ventricular Ejection Fraction (Treatment Phase)

Left Ventricular Ejection Fraction (Annual Follow-Up Phase)

Serious Infections (Treatment Phase)

Serious Infections (Annual Follow-Up Phase)

IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)

IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)

Severe Neutropenia (Treatment Phase)

Severe Neutropenia (Annual Follow-Up Phase)

Clinical Relapses (Treatment Phase)

Clinical Relapses (Annual Follow-Up Phase)

Symptomatic CHF, Left Ventricular Ejection Fraction - Prior to Each Dose ā€¢ Serious Infections, IV Antibiotics, or Assoc w/ Severe Neutropenia-evaluated. Novantrone Admin - Per PI ā€¢ SAE, Clinical Relapses

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 NovantroneĀ® therapy in patients with multiple sclerosis (MS) using dosing and monitoring recommendations specified in the package insert.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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/ĀµL

- Granulocyte count > 2000 cells/ĀµL

- 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 NovantroneĀ®

- 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 NovantroneĀ®, 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)

Locations and Contacts

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

Full FDA approved prescribing information can be found here

Starting date: October 2000
Last updated: October 21, 2013

Page last updated: August 23, 2015

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