An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor
28 november 2016 uppdaterad av: Hoffmann-La Roche
A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.
This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor.
Data will be collected from each patient from the time of change in biologic therapy for 12 months.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
1239
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Barranquilla, Colombia
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Bogota, Colombia
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Cali, Colombia
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Abbeville, Frankrike, 80142
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Aix Les Bains, Frankrike, 73106
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Amiens, Frankrike, 80000
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Amiens, Frankrike, 80094
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Argenteuil, Frankrike, 95107
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Bayonne, Frankrike, 64109
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Belfort, Frankrike, 90000
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Besancon, Frankrike, 25030
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Bonneville, Frankrike, 74136
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Bordeaux, Frankrike, 33076
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Bordeaux, Frankrike, 33100
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Boulogne-billancourt, Frankrike, 92104
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Brest, Frankrike, 29609
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Bruges, Frankrike, 33523
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Bry Sur Marne, Frankrike, 94366
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Caen, Frankrike, 14033
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Cahors, Frankrike, 46005
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Cambrai, Frankrike, 59407
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Cannes, Frankrike, 06401
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Carcassonne, Frankrike, 11890
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Carhaix Plouguer, Frankrike, 29835
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Chambray Les Tours, Frankrike, 37171
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Clermont-Ferrand, Frankrike, 63000
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Clermont-ferrand, Frankrike, 63003
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Colmar, Frankrike, 68024
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Corbeil-essonnes, Frankrike, 91106
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Draguignan, Frankrike, 83300
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Echirolles, Frankrike, 38434
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Evreux, Frankrike, 27023
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Issy Les Moulineaux, Frankrike, 92130
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La Roche Sur Yon, Frankrike, 85925
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La Source, Frankrike, 45100
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Laon, Frankrike, 02001
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Laval, Frankrike, 53015
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Le Coudray, Frankrike, 28360
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Le Kremlin Bicetre, Frankrike, 94275
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Le Mans, Frankrike, 72037
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Libourne, Frankrike, 33505
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Lievin, Frankrike, 62801
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Lille, Frankrike, 59037
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Limoges, Frankrike, 87042
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Limoges, Frankrike, 87000
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Lomme, Frankrike, 59160
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Lorient, Frankrike, 56322
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Lyon, Frankrike, 69002
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Lyon, Frankrike, 69275
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Lyon, Frankrike, 69448
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Maisons Laffitte, Frankrike, 78600
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Mantes La Jolie, Frankrike, 78201
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Marseille, Frankrike, 13285
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Marseille, Frankrike, 13385
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Mennecy, Frankrike, 91540
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Metz, Frankrike, 57077
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Montauban, Frankrike, 82017
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Montauban, Frankrike, 82013
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Montivilliers, Frankrike, 76290
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Montpellier, Frankrike, 34295
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Mulhouse, Frankrike, 68070
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Nantes, Frankrike, 44093
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Nevers, Frankrike, 58033
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Nice, Frankrike, 06202
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Pachuca, Frankrike, 42070
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Paris, Frankrike, 75018
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Paris, Frankrike, 75014
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Paris, Frankrike, 75651
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Paris, Frankrike, 75475
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Paris, Frankrike, 75674
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Paris, Frankrike, 75571
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Paris, Frankrike, 75679
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Paris, Frankrike, 75877
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Paris, Frankrike, 75020
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Perpignan, Frankrike, 66046
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Pierre Benite, Frankrike, 69495
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Reims, Frankrike, 51092
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Reims, Frankrike, 51100
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Rennes, Frankrike, 35203
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Rodez, Frankrike, 12027
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Roubaix, Frankrike, 59056
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St Aubin Les Elbeuf, Frankrike, 76410
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St Brieuc, Frankrike, 22027
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St Priest En Jarez, Frankrike, 42277
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Toulon, Frankrike, 83000
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Toulouse, Frankrike, 31059
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Toulouse, Frankrike, 31000
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Tours, Frankrike, 37000
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Valence, Frankrike, 26000
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Valenciennes, Frankrike, 59322
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Vandoeuvre-les-nancy, Frankrike, 54511
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Vannes, Frankrike, 56017
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Villeneuve Sur Lot, Frankrike, 47307
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Vincennes, Frankrike, 94300
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Athens, Grekland, 11527
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Athens, Grekland, 16673
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Athens, Grekland, 14527
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Athens, Grekland, 155 62
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Athens, Grekland, 10676
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Larissa, Grekland, 411 10
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Abruzzo
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Coppito, Abruzzo, Italien, 67100
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Basilicata
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Potenza, Basilicata, Italien, 85100
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Campania
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Napoli, Campania, Italien, 80131
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Telese Terme, Campania, Italien, 82037
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Emilia-Romagna
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Ferrara, Emilia-Romagna, Italien, 44100
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Modena, Emilia-Romagna, Italien, 41100
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Friuli-Venezia Giulia
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Udine, Friuli-Venezia Giulia, Italien, 33100
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Lombardia
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Milano, Lombardia, Italien, 20157
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Milano, Lombardia, Italien, 20162
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Marche
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Ancona, Marche, Italien, 60020
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Jesi, Marche, Italien, 60035
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Puglia
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Bari, Puglia, Italien, 70124
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San Cesario Di Lecce, Puglia, Italien, 73016
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Sicilia
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Gazzi, Sicilia, Italien, 98125
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Palermo, Sicilia, Italien, 90127
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Toscana
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Firenze, Toscana, Italien, 50139
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Pisa, Toscana, Italien, 56100
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Prato, Toscana, Italien, 59100
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Siena, Toscana, Italien, 53100
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Veneto
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Padova, Veneto, Italien, 35128
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Verona, Veneto, Italien, 37134
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Manitoba
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Winnipeg, Manitoba, Kanada, R3A 1M3
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New Brunswick
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Saint John, New Brunswick, Kanada, E4L 4L2
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Ontario
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Brampton, Ontario, Kanada, L6T 3J1
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Burlington, Ontario, Kanada, L7R 1E2
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Hamilton, Ontario, Kanada, L8N 1Y2
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Kitchener, Ontario, Kanada, N2M 5N6
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London, Ontario, Kanada, N6A 4V2
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Mississauga, Ontario, Kanada, L5M 2V8
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St. Catharines, Ontario, Kanada, L2N 7E4
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Toronto, Ontario, Kanada, M5G 1X5
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Toronto, Ontario, Kanada, M9B 1B1
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Windsor, Ontario, Kanada, N8X 5A6
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
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Montreal, Quebec, Kanada, H2L 1S6
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Montreal, Quebec, Kanada, H3T 1Y6
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Rimouski, Quebec, Kanada, G5L 8W1
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7K 0H6
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Chihuahua, Mexiko, 31238
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Mexicali, Mexiko, 21100
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Mexico City, Mexiko, 10700
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Mexico City, Mexiko, 11850
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Mexico City, Mexiko, 14141
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Pozarica, Mexiko, 93260
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Monaco, Monaco, 98012
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Ålesund, Norge, 6026
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Amadora, Portugal, 3814-501
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Guimaraes, Portugal, 4835-044
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Lisboa, Portugal, 1069-639
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Porto, Portugal, 4050-011
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Cordoba, Spanien, 14004
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Granada, Spanien, 18014
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Granada, Spanien, 18003
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Leon, Spanien, 24071
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Lugo, Spanien, 27004
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Madrid, Spanien, 28034
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Madrid, Spanien, 28905
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Madrid, Spanien, 28222
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Salamanca, Spanien, 37007
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Sevilla, Spanien, 41009
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Torrevieja, Spanien, 03186
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Murcia
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El Palmar, Murcia, Spanien, 30120
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Lorca, Murcia, Spanien, 30800
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Abergavenny, Storbritannien, NP7 7EG
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Aylesbury, Storbritannien, HP21 8AL
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Blackburn, Storbritannien, BB2 3HH
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Cambridge, Storbritannien, CB2 2QQ
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Cannock, Storbritannien, WS11 5XY
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Cardiff, Storbritannien, CF14 4XW
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Cheltenham, Storbritannien, GL53 7AN
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Chertsey, Storbritannien, KT16 0PZ
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Cosham, Storbritannien, PO6 3LY
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Derby, Storbritannien, DE1 2QY
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Durham, Storbritannien, DH15TW
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Exeter, Storbritannien, EX2 5DW
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Glasgow, Storbritannien, G12 0XH
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Harrogate, Storbritannien, HG2 7SX
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Inverness, Storbritannien, IV2 3UV
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Lancaster, Storbritannien, LA1 4RP
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Leeds, Storbritannien, LS7 4SA
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Lincoln, Storbritannien, LN2 5QY
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Liverpool, Storbritannien, L9 7AL
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London, Storbritannien, SE1 9RT
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London, Storbritannien, SW17 0QT
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London, Storbritannien, SE5 9PJ
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Manchester, Storbritannien, M13 9PT
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Poole, Storbritannien, BH15 2JB
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Salford, Storbritannien, M6 8HD
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Solihull, Storbritannien, B91 2JL
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Southport, Storbritannien, PR8 6PN
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St Helens, Storbritannien, WA9 3DA
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Stockport, Storbritannien, SK2 7JE
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Sunderland, Storbritannien, SR4 7TP
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Sutton in Ashfield, Storbritannien, NG17 4JL
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Torquay, Storbritannien, TQ2 7AA
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Truro, Storbritannien, TR1 3LJ
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Warrington, Storbritannien, WA5 1QG
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Wirral, Storbritannien, CH49 5PE
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Wolverhampton, Storbritannien, DY1 2HQ
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Worthing, Storbritannien, BN11 2DH
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Wrightington, Storbritannien, WN6 9EP
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Aachen, Tyskland, 52064
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Bremen, Tyskland, 28199
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Cuxhaven, Tyskland, 27476
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Erlangen, Tyskland, 91054
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Frankenberg, Tyskland, 09669
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Frankfurt, Tyskland, 60596
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Gräfelfing, Tyskland, 82166
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Halle, Tyskland, 06128
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Hannover, Tyskland, 30625
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Köln, Tyskland, 50679
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Münster, Tyskland, 48149
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Neuss, Tyskland, 41460
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Rostock, Tyskland, 18059
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Villingen-Schwenningen, Tyskland, 78054
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Rheumatoid arthritis patients who are non-responders or intolerant to a single TNF-inhibitor
Beskrivning
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
- Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics
Exclusion Criteria:
- Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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Rituximab
Eligible participants will receive rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
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Alternative TNFi
Eligible participants will receive alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6
Tidsram: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6
|
The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis.
It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]).
Total score ranges from 0 to 9.4, where higher score indicated more disease activity.
Decrease in score indicated improvement in disease activity.
|
Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12
Tidsram: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12
|
The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis.
It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]).
Total score ranges from 0 to 9.4, where higher score indicated more disease activity.
Decrease in score indicated improvement in disease activity.
|
Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12
|
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Least Squares Mean Change From Baseline in TJC at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA).
A total of 28 joints were assessed for tenderness.
Decrease in score indicated an improvement in disease activity.
|
Baseline, Month 6, and Month 12
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Least Squares Mean Change From Baseline in SJC at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
The SJC is the most specific clinical method to quantify abnormalities in participants with RA.
A total of 28 joints were assessed for swelling.
Decrease in the score indicated improvement in disease activity.
|
Baseline, Month 6, and Month 12
|
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Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
C-reactive protein (CRP) is an inflammation marker.
Normal range is from 0-10 milligram/Liter.
A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity.
|
Baseline, Month 6, and Month 12
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Least Squares Mean Change From Baseline in ESR at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
The ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells sediment in a period of one hour.
Normal range is 0-30 mm/hr.
A reduction in the level of ESR is considered as an improvement in disease activity.
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Baseline, Month 6, and Month 12
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Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.
Higher scores indicate worsening of disease.
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Baseline, Month 6, and Month 12
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Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.
Higher scores indicate worsening of disease.
|
Baseline, Month 6, and Month 12
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Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as "no pain" and the right edge (100 mm) defined as "severest pain".
Higher scores indicate worsening of disease.
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Baseline, Month 6, and Month 12
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Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week.
Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do.
Overall score was computed as the sum of domain scores divided by the number of domains answered.
Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty.
|
Baseline, Month 6, and Month 12
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Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12
Tidsram: Baseline, Month 6, and Month 12
|
Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.
Participants with available data at the time of assessment were included in the analysis.
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Baseline, Month 6, and Month 12
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Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy
Tidsram: Month 6 and Month 12
|
Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.
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Month 6 and Month 12
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Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice
Tidsram: Up to 12 months
|
Up to 12 months
|
|
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Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
Tidsram: Up to 12 Months
|
An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.
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Up to 12 Months
|
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Number of Participants With Reasons for Discontinuation of the First TNFi Therapy
Tidsram: Day 1 (Study entry visit)
|
The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons.
The other reasons included complete remission and participants' non-compliance.
|
Day 1 (Study entry visit)
|
|
Number of Participants With Previous TNFi Therapy
Tidsram: Day 1 (Study entry visit)
|
The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab).
Number of participants with previous TNFi therapy history was reported.
|
Day 1 (Study entry visit)
|
|
Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
Tidsram: Day 1 (Study entry visit)
|
The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin.
Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported.
|
Day 1 (Study entry visit)
|
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Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Tidsram: Baseline
|
The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi.
The participant characteristics included participant's option for treatment and option for follow-up.
The other reasons included RA disease (rheumatoid factor [RF] and cyclic citrullinated peptide [CCP] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk).
Participants were included in more than one of these factors.
|
Baseline
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2009
Primärt slutförande (Faktisk)
1 mars 2012
Avslutad studie (Faktisk)
1 mars 2012
Studieregistreringsdatum
Först inskickad
13 mars 2012
Först inskickad som uppfyllde QC-kriterierna
16 mars 2012
Första postat (Uppskatta)
19 mars 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 januari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 november 2016
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MA22401
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .