Sicherheitssicherheit und Verträglichkeit von 0,5 mg Fingolimod bei Patienten mit rezidivierenden Formen der Multiplen Sklerose

Eine einarmige, offene, multizentrische Studie zur Sicherheit und Verträglichkeit von 0,5 mg Fingolimod (FTY720), die einmalige bei Patienten mit rezidivativen Formen der Multiplen Sklerose wirdlich wird wird

Sponsoren

Hauptsponsor: Novartis Pharmaceuticals

Quelle Novartis
Kurze Zusammenfassung

Der Zweck dieser Studie war es, die Sicherheit und die Verträglichkeit, die zu sammeln ist Daten zur Lösung und zum Gesundheitsergebnis bei allen Patienten, die jetzt im Fingolimod werden Programm zur Entwicklung Entwicklung von Multipler Sklerose. Diese Studie kombinierte alle Funktionen Fingolimod-Interessenungsstudien der Phasen II und III sowie laufende und neue Studien im einleitungsbedingverlängerungsprotokoll bis Fingolimodhafte, im Handel gehört und in der ersten erstattet wurde Länder.

detaillierte Beschreibung

Diese Studie bestand aus zwei Teilen: - Teil 1, Erfassung von Daten zu gehengehender Sicherheit, Verträglichkeit, Verbesserung und Gesundheitsergebnissesen bis ca. 30-Jun-2016 bis zum Ende des Studiums (EOS) von Teil 1 und letzte Follow-up-Besuch bis Januar 2017 und - Teil 2, Sammlungsschutzter Sicherheits- und Verträglichkeitsdaten bis ca. 30. Juni 2018, in einer Untergruppe von Patienten sterben die Teil 1 Rechte haben, und andere in Frage bestimmte Patienten aus laufende Fingolimod-Versuche.

Gesamtstatus Abgeschlossen
Anfangsdatum 2010-09-13
Fertigstellungstermin 2018-10-19
Primäres Abschlussdatum 2018-10-19
Phase Phase 3
Studientyp Interventionell
Primärer Ausgang
Messen Zeitfenster
Teile I und II: Anzahl der Teilnehmer mit der Wahrnehmung der Rechte, der Wahrnehmung der Wahrnehmung und des Todes Baseline (Teil I) bis Monat 6 Follow-up (Teil II), bis zu 8 Jahre
Sekundäres Ergebnis
Messen Zeitfenster
Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Teil I: Anzahl der Teilnehmer mit Rückfällen (bestätigt und unbestätigt) ab der ersten Dosis Fingolimod Monat 0 (Kernbasis) bis zum Ende des Follow-up-Besuchs (durchschnittlich 162 Monate)
Teil I: Annualisierte Raten neuer oder neu vergrößerter T2-Läsionen (ARneT2) im Vergleich zur ersten Dosis von Fingolimod Monat 0 (Grundlinie) bis zum Ende des Studiums (Durchschnitt des Monats 156)
Teil I: Änderung der Gesamtdosis von Fingolimod gegenüber dem Gesamtvolumen der T2-Läsionen Monat 3 bis Studienende (Studienabschlussbesuch)
Teil I: Änderung der ersten Dosis von Fingolimod im Gesamtvolumen der hypointensiven T1-Läsionen Monat 3 bis Studienende (Studienabschlussbesuch)
Teil I: Prozentuale Veränderung des Gehirnvolumens (PBVC) im Verhältnis zur ersten Dosis von Fingolimod Monat 3 bis Monat 156
Teil I: Annualisierte Rate der Hirnatrophie (ARBA) im Verhältnis zur ersten Dosis von Fingolimod Monat 3 bis Monat 156
Teil I: Anzahl der Teilnehmer mit bestätigtem 6-monatigem Fortschreiten der Behinderung nach der ersten Dosis von Fingolimod Monat 12 bis Monat 156
Teil I: Anzahl der Teilnehmer mit kategorisierter Änderung gegenüber der ersten Fingolimod-Dosis in der erweiterten EDSS-Gesamtbewertung (Disability Status Scale) Follow-up von Monat 3 bis Monat 6
Teil I: Änderung der ersten Fingolimod-Dosis in der erweiterten Behinderungsstatusskala (EDSS) Monat 0 (Kernbasis) bis zum Ende des Follow-up-Besuchs (durchschnittlich 162 Monate)
Einschreibung 4125
Bedingung
Intervention

Interventionsart: Arzneimittel

Interventionsname: Fingolimod

Beschreibung: 0,5 mg / Tag

Armgruppenetikett: Fingolimod 0,5 mg / Tag

Anderer Name: FTY720

Teilnahmeberechtigung

Kriterien:

Wichtige Einschlusskriterien: - Patienten, die laufende oder die Studien mit FTY720 abgeschlossen haben. Wichtige Ausschlusskriterien: - Vorzeitiger dauerhafter Abbruch einer falschen Fingolimod-Studie. - Schwangere oder stillende Frauen. - Frauen im gebärhaften Alter, es sei denn, sie wenden zwei Verhütungsmethoden an Mindestens 1 davon muss hormonelle Empfängververhütung, Tubensterilisation, Partner sein Vasektomie oder Intrauterinpessar. - Andere chronische Zustände des Immunsystems als Multiple Sklerose, die Arbeitskräfte sind sind immunsuppressive Behandlung. - Diabetiker mit mittelschwerer oder schwer nicht proliferativer diabetischer Retinopathie oder proliferative diabetische Retinopathie und unkontrollierte Diabetiker mit HbA1c> 8%. - Aktive systemische bakterielle, virale oder Pilzinfektionen oder bekannt gewordene AIDS, Hepatitis B, Hepatitis C-Infektion oder positive HIV-Vertretung, Hepatitis B-Vertretung Antigen- oder Hepatitis-C-Tests. - Vorherige Behandlung mit Cladribin, Cyclophosphamid oder Mitoxantron. - Behandlung mit Immunglobulinen und / oder monoklonalen Antik die letzten 3 Monate der der Fingolimod-Studie: - Eine der folgenden kardiovaskbaren Zustände, die sich in der Vergangenheit entwickelt haben Fingolimod-Studie: - Myokardinfarkt verschiedene der letzten 6 Monate vor dem Eintritt in die Liste Studie oder mit politischen instabilen ischämischen Herzbehandlungen; - Herzinsuffizienz (Klasse III nach Angaben der New Yorker Herzvereinigung) Einstufung) oder eine vom Prüfer festliche schwere Herzerkrankung; - Arrhythmie, die eine Behandlung Behandlung mit Antiarrhythmika der Klasse III (z. Amiodaron, Bretylium, Sotalol, Ibutilid, Azimilid, Dofetilid) - Vorgeschichte oder Einleitung eines AV-Blocks - Nachlicheene Vorgeschichte eines Sinus-Sick-Syndroms oder eines sino-atrialen Herzblocks - Bekannte Geschichte der Angina pectoris wachsen eines Koronarkrampfes oder des Raynaud-Phänomens - Eine der folgenden Lungenprobleme, die der Fingolimod-Studie entsprechen: - Schwere Atemwegserkrankung oder Lungenfibrose Fingolimod-Studie) - Aktive Tuberkulose - Alkoholische, chronische Lebererkrankung, die der Fingolimod-Studie entspricht. Der Patient muss eine bestimmte Fingolimod-Studie haben haben, um zu sein eine dieser Studie wurde durchgeführt.

Geschlecht:

Alle

Mindestalter:

18 Jahre

Maximales Alter:

N / A

Gesunde Freiwillige:

через канал

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
Ort
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Novartis Investigative Site | Seoul, 06351, Korea, Republic of
Novartis Investigative Site | Kuala Lumpur, Wilayah Persekutuan, 50586, Malaysia
Novartis Investigative Site | Kuala Lumpur, 59100, Malaysia
Novartis Investigative Site | Breda, CK, 4818, Netherlands
Novartis Investigative Site | Amsterdam, 1061 AE, Netherlands
Novartis Investigative Site | Amsterdam, 1081 HV, Netherlands
Novartis Investigative Site | Blaricum, 1261 AN, Netherlands
Novartis Investigative Site | Enschede, 7513 ER, Netherlands
Novartis Investigative Site | Gouda, 2803 HH, Netherlands
Novartis Investigative Site | Nieuwegein, Netherlands
Novartis Investigative Site | Nijmegen, 6525 GC, Netherlands
Novartis Investigative Site | Rotterdam, 3015 CE, Netherlands
Novartis Investigative Site | Sittard-Geleen, 6162 BG, Netherlands
Novartis Investigative Site | Tilburg, 5022 GC, Netherlands
Novartis Investigative Site | Lillehammer, 2629, Norway
Novartis Investigative Site | Molde, 6412, Norway
Novartis Investigative Site | Stavanger, 4068, Norway
Novartis Investigative Site | Panama City, 0801, Panama
Novartis Investigative Site | Panama City, Panama
Novartis Investigative Site | La Perla, Callao, 04, Peru
Novartis Investigative Site | Jesus Maria, Lima, 11, Peru
Novartis Investigative Site | San Isidro, Lima, 27, Peru
Novartis Investigative Site | Bialystok, 15-276, Poland
Novartis Investigative Site | Bialystok, 15-420, Poland
Novartis Investigative Site | Bydgoszcz, 85 681, Poland
Novartis Investigative Site | Gdansk, 80-803, Poland
Novartis Investigative Site | Katowice, 40 571, Poland
Novartis Investigative Site | Katowice, 40-648, Poland
Novartis Investigative Site | Lodz, 90 324, Poland
Novartis Investigative Site | Poznan, 60-355, Poland
Novartis Investigative Site | Warszawa, 02-097, Poland
Novartis Investigative Site | Warszawa, 02-507, Poland
Novartis Investigative Site | Warszawa, 02-957, Poland
Novartis Investigative Site | Warszawa, 04141, Poland
Novartis Investigative Site | Amadora, 2720-276, Portugal
Novartis Investigative Site | Coimbra, 3000075, Portugal
Novartis Investigative Site | Lisboa, 1150 314, Portugal
Novartis Investigative Site | Porto, 4099-001, Portugal
Novartis Investigative Site | Porto, 4200 319, Portugal
Novartis Investigative Site | Setubal, 2910-446, Portugal
Novartis Investigative Site | Bucharest, 010825, Romania
Novartis Investigative Site | Bucharest, 011461, Romania
Novartis Investigative Site | Bucharest, 050098, Romania
Novartis Investigative Site | Craiova, 200620, Romania
Novartis Investigative Site | Targu Mures, 540136, Romania
Novartis Investigative Site | Samara, Samara Region, 443095, Russian Federation
Novartis Investigative Site | Ekaterinburg, 620109, Russian Federation
Novartis Investigative Site | Kazan, 420021, Russian Federation
Novartis Investigative Site | Kazan, 420097, Russian Federation
Novartis Investigative Site | Moscow, 101990, Russian Federation
Novartis Investigative Site | Moscow, 121359, Russian Federation
Novartis Investigative Site | Moscow, 125367, Russian Federation
Novartis Investigative Site | Moscow, 127018, Russian Federation
Novartis Investigative Site | Nizhny Novgorod, 603018, Russian Federation
Novartis Investigative Site | Nizhny Novgorod, 603155, Russian Federation
Novartis Investigative Site | Saint Petersburg, 194044, Russian Federation
Novartis Investigative Site | Smolensk, 214019, Russian Federation
Novartis Investigative Site | St. Petersburg, 194291, Russian Federation
Novartis Investigative Site | St. Petersburg, 197376, Russian Federation
Novartis Investigative Site | Bratislava, Slovak Republic, 84103, Slovakia
Novartis Investigative Site | Bratislava, 813 69, Slovakia
Novartis Investigative Site | Bratislava, 826 06, Slovakia
Novartis Investigative Site | Martin, 036 59, Slovakia
Novartis Investigative Site | Trnava, 917 75, Slovakia
Novartis Investigative Site | Cape Town, 7925, South Africa
Novartis Investigative Site | Durban, South Africa
Novartis Investigative Site | Rosebank, 2196, South Africa
Novartis Investigative Site | Malaga, Andalucia, 29010, Spain
Novartis Investigative Site | Sevilla, Andalucia, 41009, Spain
Novartis Investigative Site | Barcelona, Catalunya, 08035, Spain
Novartis Investigative Site | Barcelona, Catalunya, 08036, Spain
Novartis Investigative Site | L Hospitalet De Llobregat, Catalunya, 08907, Spain
Novartis Investigative Site | Valencia, Comunidad Valenciana, 46010, Spain
Novartis Investigative Site | Valencia, Comunidad Valenciana, 46026, Spain
Novartis Investigative Site | Santiago de Compostela, Galicia, 15706, Spain
Novartis Investigative Site | Bilbao, Pais Vasco, 48013, Spain
Novartis Investigative Site | San Sebastian, Pais Vasco, 20080, Spain
Novartis Investigative Site | Barcelona, 08041, Spain
Novartis Investigative Site | Madrid, 28034, Spain
Novartis Investigative Site | Madrid, 28040, Spain
Novartis Investigative Site | Madrid, 28046, Spain
Novartis Investigative Site | Madrid, 28222, Spain
Novartis Investigative Site | Santa Cruz de Tenerife, 38009, Spain
Novartis Investigative Site | Goeteborg, 413 45, Sweden
Novartis Investigative Site | Linkoping, SE 581 85, Sweden
Novartis Investigative Site | Stockholm, 102 35, Sweden
Novartis Investigative Site | Stockholm, 14186, Sweden
Novartis Investigative Site | Umea, 901 85, Sweden
Novartis Investigative Site | Aarau, 5001, Switzerland
Novartis Investigative Site | Basel, 4031, Switzerland
Novartis Investigative Site | Carouge, 1227, Switzerland
Novartis Investigative Site | Lausanne, 1011, Switzerland
Novartis Investigative Site | Lugano, 6900, Switzerland
Novartis Investigative Site | St Gallen, 9007, Switzerland
Novartis Investigative Site | Zuerich, 8091, Switzerland
Novartis Investigative Site | Istanbul, TUR, 34098, Turkey
Novartis Investigative Site | Ankara, 06100, Turkey
Novartis Investigative Site | Ankara, 06500, Turkey
Novartis Investigative Site | Antalya, 07070, Turkey
Novartis Investigative Site | Gaziantep, 27310, Turkey
Novartis Investigative Site | Haseki / Istanbul, 34096, Turkey
Novartis Investigative Site | Istanbul, 34093, Turkey
Novartis Investigative Site | Istanbul, 34147, Turkey
Novartis Investigative Site | Istanbul, 34722, Turkey
Novartis Investigative Site | Izmir, 35040, Turkey
Novartis Investigative Site | Izmir, 35340, Turkey
Novartis Investigative Site | Mersin, 33079, Turkey
Novartis Investigative Site | Samsun, 55139, Turkey
Novartis Investigative Site | Trabzon, 61080, Turkey
Novartis Investigative Site | Yenisehir / Izmir, Turkey
Novartis Investigative Site | Truro, Cornwall, TR1 3LJ, United Kingdom
Novartis Investigative Site | Brighton, East Sussex, BN2 5BE, United Kingdom
Novartis Investigative Site | Salford, Manchester, M6 8HD, United Kingdom
Novartis Investigative Site | Headington, Oxfordshire, OX3 9DU, United Kingdom
Novartis Investigative Site | Sheffield, South Yorkshire, S10 2JF, United Kingdom
Novartis Investigative Site | Stoke on Trent, Staffordshire, ST46QG, United Kingdom
Novartis Investigative Site | Birmingham, B15 2TH, United Kingdom
Novartis Investigative Site | Bristol, BS10 5NB, United Kingdom
Novartis Investigative Site | Dundee, DD1 9SY, United Kingdom
Novartis Investigative Site | Edinburgh, EH4 2XU, United Kingdom
Novartis Investigative Site | Essex, RM7 0BE, United Kingdom
Novartis Investigative Site | Great Yarmouth, NR31 6LA, United Kingdom
Novartis Investigative Site | Liverpool, L9 7LJ, United Kingdom
Novartis Investigative Site | London, SE22 8PT, United Kingdom
Novartis Investigative Site | London, SW17 0QT, United Kingdom
Novartis Investigative Site | London, W8 6RF, United Kingdom
Novartis Investigative Site | Middlesbrough, TS4 3BW, United Kingdom
Novartis Investigative Site | Newcastle Upon Tyne, NE1 4LP, United Kingdom
Novartis Investigative Site | Northampton, NN1 5BD, United Kingdom
Novartis Investigative Site | Nottingham, NG7 2UH, United Kingdom
Novartis Investigative Site | Poole, BH15 2JB, United Kingdom
Novartis Investigative Site | Swindon, SN3 6BB, United Kingdom
Standort Länder

Argentina

Australia

Austria

Belgium

Brazil

Canada

Czechia

Denmark

Egypt

Estonia

Finland

France

Germany

Greece

Guatemala

Hungary

Ireland

Israel

Italy

Jordan

Korea, Republic of

Malaysia

Netherlands

Norway

Panama

Peru

Poland

Portugal

Romania

Russian Federation

Slovakia

South Africa

Spain

Sweden

Switzerland

Turkey

United Kingdom

United States

Überprüfungsdatum

2021-03-01

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert через канал
Anzahl der Waffen 1
Armgruppe

Etikette: Fingolimod 0,5 mg / Tag

Art: Experimental

Beschreibung: Open-Label-Fingolimod 0,5 mg, einmal täglich oral eingenommen

Studiendesign Info

Zuweisung: N / A

Interventionsmodell: Einzelgruppenzuordnung

Hauptzweck: Behandlung

Maskierung: Keine (Open Label)

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