Multiple SclerosisRENEWNCT00262314
Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
An observational study of Multiple Sclerosis, run by EMD Serono at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 509 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Sep 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- AST, ALT, bilirubin > 2x upper limits of normal
- Severe untreated infection (including current urinary tract infection)
- Nursing or pregnant women)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Congestive Heart Failure (Treatment Phase)
Number of patients experiencing congestive heart failure during the treatment phase of the trial
Measured: up to 36 months
Congestive Heart Failure (Annual Follow-Up Phase)
Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
Measured: up to 5 years
Left Ventricular Ejection Fraction (Treatment Phase)
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the treatment phase of the trial
Measured: up to 36 months
Left Ventricular Ejection Fraction (Annual Follow-Up Phase)
Number of patients with left ventricular ejection fraction test results that decreased below 50% during the annual follow-up phase of the trial
Measured: up to 5 years
Serious Infections (Treatment Phase)
Number of serious infections during the treatment phase of the trial
Measured: up to 36 months
Serious Infections (Annual Follow-Up Phase)
Number of serious infections during the annual follow-up phase of the trial
Measured: up to 5 years
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)
Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
Measured: up to 36 months
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)
Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
Measured: up to 5 years
Severe Neutropenia (Treatment Phase)
Number of infections associated with severe neutropenia at onset during the treatment phase
Measured: up to 36 months
Severe Neutropenia (Annual Follow-Up Phase)
Number of infections associated with severe neutropenia at onset during the annual follow-up phase
Measured: up to 5 years
Clinical Relapses (Treatment Phase)
Number of clinical relapses reported during the treatment phase of the trial
Measured: up to 36 months
Clinical Relapses (Annual Follow-Up Phase)
Number of clinical relapses reported during the annual follow-up phase of the trial
Measured: up to 5 years
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
Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startOct 2000
- Primary completionJan 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randy Bennett, Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262314
- Sponsor's protocol ID
- 24293
- Other IDs
- 19-297
- Acronym
- RENEW
- Status last verified
- Oct 2013
- First submitted
- 5 Dec 2005
- Last updated
- 14 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT00262314
- Acronym / sponsor ID
- RENEW / 24293
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Jan 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Dec 2005 (estimated)
- Results
- Posted 23 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Congestive Heart Failure (Treatment Phase)
Time frame: up to 36 months
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
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
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
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
Number of serious infections during the treatment phase of the trial
Serious Infections (Annual Follow-Up Phase)
Time frame: up to 5 years
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
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
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
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
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
Number of clinical relapses reported during the treatment phase of the trial
Clinical Relapses (Annual Follow-Up Phase)
Time frame: up to 5 years
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
Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randy Bennett study director
EMD Serono
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by EMD Serono at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Congestive Heart Failure (Treatment Phase) (time frame: up to 36 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.