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

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)