Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients (RENEW)
This study has been completed.
Sponsor:
EMD Serono
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00262314
First received: December 5, 2005
Last updated: August 23, 2011
Last verified: August 2011
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Purpose
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients |
Resource links provided by NLM:
Further study details as provided by EMD Serono:
Primary Outcome Measures:
- Congestive Heart Failure (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]Number of patients experiencing congestive heart failure during the treatment phase of the trial
- Congestive Heart Failure (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
- Left Ventricular Ejection Fraction (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial
- Left Ventricular Ejection Fraction (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial
- Serious Infections (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]Number of serious infections during the treatment phase of the trial
- Serious Infections (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]Number of serious infections during the annual follow-up phase of the trial
- IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
- IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
- Severe Neutropenia (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]Number of infections associated with severe neutropenia at onset during the treatment phase
- Severe Neutropenia (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]Number of infections associated with severe neutropenia at onset during the annual follow-up phase
- Clinical Relapses (Treatment Phase) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]Number of clinical relapses reported during the treatment phase of the trial
- Clinical Relapses (Annual Follow-Up Phase) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]Number of clinical relapses reported during the annual follow-up phase of the trial
- 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 ] [ Designated as safety issue: Yes ]Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
| Enrollment: | 509 |
| Study Start Date: | October 2000 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00262314 History of Changes |
| Obsolete Identifiers: | NCT00016614 |
| Other Study ID Numbers: | 24293, 19-297 |
| Study First Received: | December 5, 2005 |
| Results First Received: | May 21, 2010 |
| Last Updated: | August 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
Mitoxantrone Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013