Prospective, Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients (RENEW)
21. oktober 2013 oppdatert av: EMD Serono
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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
509
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Kentucky
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Lexington, Kentucky, Forente stater, 40504-3276
- Registrat Inc
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Congestive Heart Failure (Treatment Phase)
Tidsramme: up to 36 months
|
Number of patients experiencing congestive heart failure during the treatment phase of the trial
|
up to 36 months
|
|
Congestive Heart Failure (Annual Follow-Up Phase)
Tidsramme: up to 5 years
|
Number of patients experiencing congestive heart failure during the annual follow-up phase of the trial
|
up to 5 years
|
|
Left Ventricular Ejection Fraction (Treatment Phase)
Tidsramme: 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
|
up to 36 months
|
|
Left Ventricular Ejection Fraction (Annual Follow-Up Phase)
Tidsramme: 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
|
up to 5 years
|
|
Serious Infections (Treatment Phase)
Tidsramme: up to 36 months
|
Number of serious infections during the treatment phase of the trial
|
up to 36 months
|
|
Serious Infections (Annual Follow-Up Phase)
Tidsramme: up to 5 years
|
Number of serious infections during the annual follow-up phase of the trial
|
up to 5 years
|
|
IV Antibiotics (Individual Drugs Unspecified) Utilized Due to Serious Infection (Treatment Phase)
Tidsramme: up to 36 months
|
Number of subjects in whom IV antibiotics were utilized due to serious infection during the treatment phase
|
up to 36 months
|
|
IV Antibiotics (Individual Drugs Unspecified) Utilized Due To Serious Infection (Annual Follow-Up Phase)
Tidsramme: up to 5 years
|
Number of subjects in whom IV antibiotics were utilized due to serious infection during the annual follow-up phase
|
up to 5 years
|
|
Severe Neutropenia (Treatment Phase)
Tidsramme: up to 36 months
|
Number of infections associated with severe neutropenia at onset during the treatment phase
|
up to 36 months
|
|
Severe Neutropenia (Annual Follow-Up Phase)
Tidsramme: up to 5 years
|
Number of infections associated with severe neutropenia at onset during the annual follow-up phase
|
up to 5 years
|
|
Clinical Relapses (Treatment Phase)
Tidsramme: up to 36 months
|
Number of clinical relapses reported during the treatment phase of the trial
|
up to 36 months
|
|
Clinical Relapses (Annual Follow-Up Phase)
Tidsramme: up to 5 years
|
Number of clinical relapses reported during the annual follow-up phase of the trial
|
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
Tidsramme: up to 5 years
|
Outcomes are presented separately above apart from adverse events which are presented in the adverse event section
|
up to 5 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Randy Bennett, EMD Serono
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2000
Primær fullføring (Faktiske)
1. januar 2008
Studiet fullført (Faktiske)
1. september 2008
Datoer for studieregistrering
Først innsendt
5. desember 2005
Først innsendt som oppfylte QC-kriteriene
5. desember 2005
Først lagt ut (Anslag)
6. desember 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. november 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. oktober 2013
Sist bekreftet
1. oktober 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 24293
- 19-297
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