An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
12 de enero de 2016 actualizado por: Hoffmann-La Roche
A Global Comparative Observational Study In Rheumatoid Arthritis (RA) Patients Who Are Treated With A TNF Inhibitor Or Tocilizumab As The First Biologic Therapy
This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy.
Data will be collected for 52 weeks.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
1225
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Aachen, Alemania, 52064
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Bad Aibling, Alemania, 83043
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Bad Neuenahr-Ahrweiler, Alemania, 53474
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Bayreuth, Alemania, 95445
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Berlin, Alemania, 13055
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Dresden, Alemania, 01109
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Erfurt, Alemania, 99096
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Erlangen, Alemania, 91056
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Fulda, Alemania, 36043
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Hamburg, Alemania, 22767
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Hamburg, Alemania, 22147
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Heidelberg, Alemania, 69121
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Herne, Alemania, 44652
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Köln, Alemania, 50937
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Ludwigsfelde, Alemania, 14974
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München, Alemania, 81541
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München, Alemania, 80639
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Passau, Alemania, 94032
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Rostock, Alemania, 18059
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Stuttgart, Alemania, 70178
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Traunstein, Alemania, 83278
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Wuppertal, Alemania, 42105
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Catamarca Capital, Argentina, 4700
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Mendoza, Argentina, 5500
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Mendoza, Argentina, 5501
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Rosario, Argentina, S2000PBJ
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AYE, Bélgica, 6900
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Aalst, Bélgica, 9300
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Assebroek, Bélgica, 8310
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Bruxelles, Bélgica, 1050
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Bruxelles, Bélgica, 1000
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Edegem, Bélgica, 2650
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Genk, Bélgica, 3600
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Gent, Bélgica, 9000
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Godinne, Bélgica, 5530
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Heusy, Bélgica, 4802
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Liège, Bélgica, 4000
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Oostende, Bélgica, 8400
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Verviers, Bélgica, 4800
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Westmalle, Bélgica, 2390
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Barranquilla, Colombia
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Bogota, Colombia
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Bucaramanga, Colombia
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Medellin, Colombia
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Cuenca, Ecuador
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Esmeraldas, Ecuador, EC080150
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Guayaquil, Ecuador, EC090114
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Portoviejo, Ecuador
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Quito, Ecuador, 005932
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Quito, Ecuador, EC170135
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Quito, Ecuador, EC170412
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Madrid, España, 28006
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Madrid, España, 28905
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Madrid, España, 28007
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Madrid
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Fuenlabrada, Madrid, España, 28942
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San Sebastian de los Reyes, Madrid, España, 28702
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Athens, Grecia, 11527
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Athens, Grecia, 155 62
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Patra, Grecia, 26335
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Thessaloniki, Grecia, 56429
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Thessaloniki, Grecia, 544 65
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Ciudad de Guatemala, Guatemala
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Abruzzo
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Coppito, Abruzzo, Italia, 67100
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Pescara, Abruzzo, Italia, 65100
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Calabria
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Reggio Calabria, Calabria, Italia, 89133
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Campania
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Avellino, Campania, Italia, 83100
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Napoli, Campania, Italia, 80131
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Napoli, Campania, Italia, 80144
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Salerno, Campania, Italia, 84131
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Friuli-Venezia Giulia
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Udine, Friuli-Venezia Giulia, Italia, 33100
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Lazio
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Roma, Lazio, Italia, 00133
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Roma, Lazio, Italia, 00189
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Liguria
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Arenzano, Liguria, Italia, 16011
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Lombardia
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Brescia, Lombardia, Italia, 25123
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Legnano, Lombardia, Italia, 20025
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Milano, Lombardia, Italia, 20157
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Milano, Lombardia, Italia, 20162
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Marche
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Jesi Ancona, Marche, Italia, 60035
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Molise
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Agnone, Molise, Italia, 86081
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Piemonte
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Torino, Piemonte, Italia, 10126
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Torino, Piemonte, Italia, 10128
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Puglia
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Brindisi, Puglia, Italia, 72100
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Martina Franca, Puglia, Italia, 74015
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San Cesario Di Lecce, Puglia, Italia, 73016
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Sicilia
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Catania, Sicilia, Italia, 95124
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Toscana
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Prato, Toscana, Italia, 59100
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Umbria
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Perugia, Umbria, Italia, 06122
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Guadalajara, México, 44650
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Guadalajara, México, 44600
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Guadalajara, México, 45040
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Mexicali, México, 21100
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Mexico Ctiy, México, 07760
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Panama City, Panamá, 32400
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Almada, Portugal, 2801-951
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Amadora, Portugal, 2720-276
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Lisboa, Portugal, 1649-035
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Lisboa, Portugal, 1069-166
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Porto, Portugal, 4200-319
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Porto, Portugal, 4099-001
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Vila Nova de Gaia, Portugal, 4400-129
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Barnsley, Reino Unido, S75 2EP
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Basildon, Reino Unido, SS16 5NL
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Basingstoke, Reino Unido, RG24 9NA
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Brighton, Reino Unido, BN2 5BE
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Cannock, Reino Unido, WS11 5XY
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Cardiff, Reino Unido, CF14 4XW
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Chertsey, Reino Unido, KT16 0PZ
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Crawley, Reino Unido, RH11 7DH
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Darlington, Reino Unido, DL3 6HX
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Enfield, Reino Unido, EN2 8JL
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Grimsby, Reino Unido, DN33 2BA
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Guildford, Reino Unido, GU2 7XX
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Ipswich, Reino Unido, IP4 5PD
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Kettering, Reino Unido, NN16 8UZ
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Lancaster, Reino Unido, LA1 4RP
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Leeds, Reino Unido, LS7 4SA
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Llandudno, Reino Unido, LL30 1LB
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London, Reino Unido, W6 8RF
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London, Reino Unido, SW17 0QT
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London, Reino Unido, SE18 4QH
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Luton, Reino Unido, LU4 0DZ
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Maidstone, Reino Unido, ME16 9QQ
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Margate, Reino Unido, CT9 4AN
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North Shields, Reino Unido, NE29 8NH
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Oswestry, Reino Unido, SY10 7AG
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Plymouth, Reino Unido, PL6 8DH
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Portsmouth, Reino Unido, PO6 3LY
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Reading, Reino Unido, RG1 5AN
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Rhyl, Reino Unido, LL18 5UJ
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Romford, Reino Unido, RM7 0AG
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Sheffield, Reino Unido, S10 2JF
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Stockport, Reino Unido, SK2 7JE
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Sunderland, Reino Unido, SR4 7TP
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Swindon, Reino Unido, SN3 6BB
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Torquay, Reino Unido, TQ2 7AA
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Warrington, Reino Unido, WA5 1QG
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Wirral, Reino Unido, CH49 5PE
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Wolverhampton, Reino Unido, WV10 0QP
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Wrightington, Reino Unido, WN6 9EP
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Aarau, Suiza, 5000
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Basel, Suiza, 4031
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Chur, Suiza, 7000
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St. Gallen, Suiza, 9007
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Donetsk, Ucrania, 83045
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Kharkiv, Ucrania, 61052
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Kmelnytskyy, Ucrania, 29000
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Kyiv, Ucrania, 02125
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Kyiv, Ucrania, 03151
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Kyiv, Ucrania, 1023
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Odesa, Ucrania, 65026
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Uzhgorod, Ucrania, 88000
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Zaporizhzhya, Ucrania, 69600
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Montevideo, Uruguay, 11000
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Montevideo, Uruguay, 11800
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
Adult patients with rheumatoid arthritis
Descripción
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Diagnosis of rheumatoid arthritis
- Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
- Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed
Exclusion Criteria:
- Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
- Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
- Patients whose first biologic is rituximab, abatacept or anakinra.
- Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Grupo
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
Periodo de tiempo: Baseline and Week 24
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Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)].
For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR).
Higher the scores, greater is the disease activity.
A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Week 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
Periodo de tiempo: Baseline and Week 52
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Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L).
For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR).
Higher the scores, greater is the disease activity.
A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Week 52
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Mean Change From Baseline in Erythrocyte Sedimentation Rate
Periodo de tiempo: Baseline, Week 24, Week 52
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Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation.
BL = baseline.
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Baseline, Week 24, Week 52
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Mean Change From Baseline in C-reactive Protein
Periodo de tiempo: Baseline, Week 24, Week 52
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Blood samples were collected for C-reactive protein (CRP).
CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
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Baseline, Week 24, Week 52
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Mean Change From Baseline in Swollen Joint Count
Periodo de tiempo: Baseline, Week 24, Week 52
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A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
Twenty-eight joints were assessed for swelling.
Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.
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Baseline, Week 24, Week 52
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Mean Change From Baseline in Tender Joint Count
Periodo de tiempo: Baseline, Week 24, Week 52
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A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
Twenty-eight joints were assessed for tenderness.
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.
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Baseline, Week 24, Week 52
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Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score
Periodo de tiempo: Baseline, Week 24, Week 52
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Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity.
VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'.
CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity.
Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP.
SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.
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Baseline, Week 24, Week 52
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Mean Change From Baseline in Physician Global Assessment Score
Periodo de tiempo: Baseline, Week 24, Week 52
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The Physician's Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS.
The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).
Change from baseline = scores at observation minus score at baseline.
An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
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Baseline, Week 24, Week 52
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Loss of Efficacy or Development of Intolerance to Biologic Therapy
Periodo de tiempo: Up to Week 52
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Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy.
Lack of efficacy was one of the reasons for termination of biology therapy.
The number of participants showing lack of efficacy to biologic therapy is presented.
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Up to Week 52
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Proportion of Participants Who Terminated Biologic Treatment
Periodo de tiempo: Up to Week 52
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The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.
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Up to Week 52
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Reasons for Treatment Discontinuation
Periodo de tiempo: Up to Week 52
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The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.
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Up to Week 52
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Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period
Periodo de tiempo: Up to end of treatment
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The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented.
Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as 'censored' at the date study termination.
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Up to end of treatment
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Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy
Periodo de tiempo: Up to Week 52
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An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions.
Injection site reactions were included in the summaries for infusion reactions.
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Up to Week 52
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Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events
Periodo de tiempo: Up to Week 52
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An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
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Up to Week 52
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Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study
Periodo de tiempo: Up to Week 52
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Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.
Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.
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Up to Week 52
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Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score
Periodo de tiempo: Baseline, Week 24, Week 52
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The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living).
Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area).
HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild
functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
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Baseline, Week 24, Week 52
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Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score
Periodo de tiempo: Baseline, Week 24, Week 52
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Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire.
Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much).
The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue.
The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score).
A higher score reflects an improvement in the participant's health status.
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Baseline, Week 24, Week 52
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Mean Change From Baseline in Visual Analogue Scale Pain Score
Periodo de tiempo: Baseline, Week 24, Week 52
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VAS is a 100 mm scale.
Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.
Change from baseline =scores at observation minus score at baseline.
An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
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Baseline, Week 24, Week 52
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Shift From Baseline in Morning Stiffness
Periodo de tiempo: Baseline, Week 24, Week 52
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Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm.
For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day.
Baseline = BL
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Baseline, Week 24, Week 52
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Change From Baseline in Patient Global Assessment of Disease Activity
Periodo de tiempo: Baseline, Week 24, Week 52
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The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant.
The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).
A negative change from Baseline indicated improvement.
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Baseline, Week 24, Week 52
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2012
Finalización primaria (Actual)
1 de febrero de 2015
Finalización del estudio (Actual)
1 de febrero de 2015
Fechas de registro del estudio
Enviado por primera vez
28 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
28 de febrero de 2012
Publicado por primera vez (Estimar)
5 de marzo de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
10 de febrero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
12 de enero de 2016
Última verificación
1 de enero de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MA27950
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .