Clinical trial NCT00262314: Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
Official title: Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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

Eligibility 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/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)

Primary outcomes:
measure: Congestive Heart Failure (Treatment Phase)
timeFrame: up to 36 months
measure: Congestive Heart Failure (Annual Follow-Up Phase)
timeFrame: up to 5 years
measure: Left Ventricular Ejection Fraction (Treatment Phase)
timeFrame: up to 36 months
measure: Left Ventricular Ejection Fraction (Annual Follow-Up Phase)
timeFrame: up to 5 years
measure: Serious Infections (Treatment Phase)
timeFrame: up to 36 months
measure: Serious Infections (Annual Follow-Up Phase)
timeFrame: up to 5 years
measure: IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)
timeFrame: up to 36 months
measure: IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)
timeFrame: up to 5 years
measure: Severe Neutropenia (Treatment Phase)
timeFrame: up to 36 months
measure: Severe Neutropenia (Annual Follow-Up Phase)
timeFrame: up to 5 years
measure: Clinical Relapses (Treatment Phase)
timeFrame: up to 36 months
measure: Clinical Relapses (Annual Follow-Up Phase)
timeFrame: up to 5 years
measure: 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
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Registrat Inc
state: Kentucky
Study officials:
affiliation: EMD Serono
name: Randy Bennett
role: STUDY_DIRECTOR
References: