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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 de noviembre de 2016 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

De observación

Inscripción (Actual)

1239

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

  • Alemania
      • Aachen, Alemania, 52064
      • Bremen, Alemania, 28199
      • Cuxhaven, Alemania, 27476
      • Erlangen, Alemania, 91054
      • Frankenberg, Alemania, 09669
      • Frankfurt, Alemania, 60596
      • Gräfelfing, Alemania, 82166
      • Halle, Alemania, 06128
      • Hannover, Alemania, 30625
      • Köln, Alemania, 50679
      • Münster, Alemania, 48149
      • Neuss, Alemania, 41460
      • Rostock, Alemania, 18059
      • Villingen-Schwenningen, Alemania, 78054
  • Canadá
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3A 1M3
    • New Brunswick
      • Saint John, New Brunswick, Canadá, E4L 4L2
    • Ontario
      • Brampton, Ontario, Canadá, L6T 3J1
      • Burlington, Ontario, Canadá, L7R 1E2
      • Hamilton, Ontario, Canadá, L8N 1Y2
      • Kitchener, Ontario, Canadá, N2M 5N6
      • London, Ontario, Canadá, N6A 4V2
      • Mississauga, Ontario, Canadá, L5M 2V8
      • St. Catharines, Ontario, Canadá, L2N 7E4
      • Toronto, Ontario, Canadá, M5G 1X5
      • Toronto, Ontario, Canadá, M9B 1B1
      • Windsor, Ontario, Canadá, N8X 5A6
    • Quebec
      • Montreal, Quebec, Canadá, H1T 2M4
      • Montreal, Quebec, Canadá, H2L 1S6
      • Montreal, Quebec, Canadá, H3T 1Y6
      • Rimouski, Quebec, Canadá, G5L 8W1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canadá, S7K 0H6
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Cali, Colombia
  • España
      • Cordoba, España, 14004
      • Granada, España, 18014
      • Granada, España, 18003
      • Leon, España, 24071
      • Lugo, España, 27004
      • Madrid, España, 28034
      • Madrid, España, 28905
      • Madrid, España, 28222
      • Salamanca, España, 37007
      • Sevilla, España, 41009
      • Torrevieja, España, 03186
    • Murcia
      • El Palmar, Murcia, España, 30120
      • Lorca, Murcia, España, 30800
  • Francia
      • Abbeville, Francia, 80142
      • Aix Les Bains, Francia, 73106
      • Amiens, Francia, 80000
      • Amiens, Francia, 80094
      • Argenteuil, Francia, 95107
      • Bayonne, Francia, 64109
      • Belfort, Francia, 90000
      • Besancon, Francia, 25030
      • Bonneville, Francia, 74136
      • Bordeaux, Francia, 33076
      • Bordeaux, Francia, 33100
      • Boulogne-billancourt, Francia, 92104
      • Brest, Francia, 29609
      • Bruges, Francia, 33523
      • Bry Sur Marne, Francia, 94366
      • Caen, Francia, 14033
      • Cahors, Francia, 46005
      • Cambrai, Francia, 59407
      • Cannes, Francia, 06401
      • Carcassonne, Francia, 11890
      • Carhaix Plouguer, Francia, 29835
      • Chambray Les Tours, Francia, 37171
      • Clermont-Ferrand, Francia, 63000
      • Clermont-ferrand, Francia, 63003
      • Colmar, Francia, 68024
      • Corbeil-essonnes, Francia, 91106
      • Draguignan, Francia, 83300
      • Echirolles, Francia, 38434
      • Evreux, Francia, 27023
      • Issy Les Moulineaux, Francia, 92130
      • La Roche Sur Yon, Francia, 85925
      • La Source, Francia, 45100
      • Laon, Francia, 02001
      • Laval, Francia, 53015
      • Le Coudray, Francia, 28360
      • Le Kremlin Bicetre, Francia, 94275
      • Le Mans, Francia, 72037
      • Libourne, Francia, 33505
      • Lievin, Francia, 62801
      • Lille, Francia, 59037
      • Limoges, Francia, 87042
      • Limoges, Francia, 87000
      • Lomme, Francia, 59160
      • Lorient, Francia, 56322
      • Lyon, Francia, 69002
      • Lyon, Francia, 69275
      • Lyon, Francia, 69448
      • Maisons Laffitte, Francia, 78600
      • Mantes La Jolie, Francia, 78201
      • Marseille, Francia, 13285
      • Marseille, Francia, 13385
      • Mennecy, Francia, 91540
      • Metz, Francia, 57077
      • Montauban, Francia, 82017
      • Montauban, Francia, 82013
      • Montivilliers, Francia, 76290
      • Montpellier, Francia, 34295
      • Mulhouse, Francia, 68070
      • Nantes, Francia, 44093
      • Nevers, Francia, 58033
      • Nice, Francia, 06202
      • Pachuca, Francia, 42070
      • Paris, Francia, 75018
      • Paris, Francia, 75014
      • Paris, Francia, 75651
      • Paris, Francia, 75475
      • Paris, Francia, 75674
      • Paris, Francia, 75571
      • Paris, Francia, 75679
      • Paris, Francia, 75877
      • Paris, Francia, 75020
      • Perpignan, Francia, 66046
      • Pierre Benite, Francia, 69495
      • Reims, Francia, 51092
      • Reims, Francia, 51100
      • Rennes, Francia, 35203
      • Rodez, Francia, 12027
      • Roubaix, Francia, 59056
      • St Aubin Les Elbeuf, Francia, 76410
      • St Brieuc, Francia, 22027
      • St Priest En Jarez, Francia, 42277
      • Toulon, Francia, 83000
      • Toulouse, Francia, 31059
      • Toulouse, Francia, 31000
      • Tours, Francia, 37000
      • Valence, Francia, 26000
      • Valenciennes, Francia, 59322
      • Vandoeuvre-les-nancy, Francia, 54511
      • Vannes, Francia, 56017
      • Villeneuve Sur Lot, Francia, 47307
      • Vincennes, Francia, 94300
  • Grecia
      • Athens, Grecia, 11527
      • Athens, Grecia, 16673
      • Athens, Grecia, 14527
      • Athens, Grecia, 155 62
      • Athens, Grecia, 10676
      • Larissa, Grecia, 411 10
  • Italia
    • Abruzzo
      • Coppito, Abruzzo, Italia, 67100
    • Basilicata
      • Potenza, Basilicata, Italia, 85100
    • Campania
      • Napoli, Campania, Italia, 80131
      • Telese Terme, Campania, Italia, 82037
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italia, 44100
      • Modena, Emilia-Romagna, Italia, 41100
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italia, 33100
    • Lombardia
      • Milano, Lombardia, Italia, 20157
      • Milano, Lombardia, Italia, 20162
    • Marche
      • Ancona, Marche, Italia, 60020
      • Jesi, Marche, Italia, 60035
    • Puglia
      • Bari, Puglia, Italia, 70124
      • San Cesario Di Lecce, Puglia, Italia, 73016
    • Sicilia
      • Gazzi, Sicilia, Italia, 98125
      • Palermo, Sicilia, Italia, 90127
    • Toscana
      • Firenze, Toscana, Italia, 50139
      • Pisa, Toscana, Italia, 56100
      • Prato, Toscana, Italia, 59100
      • Siena, Toscana, Italia, 53100
    • Veneto
      • Padova, Veneto, Italia, 35128
      • Verona, Veneto, Italia, 37134
  • México
      • Chihuahua, México, 31238
      • Mexicali, México, 21100
      • Mexico City, México, 10700
      • Mexico City, México, 11850
      • Mexico City, México, 14141
      • Pozarica, México, 93260
  • Mónaco
      • Monaco, Mónaco, 98012
  • Noruega
      • Ålesund, Noruega, 6026
  • Portugal
      • Amadora, Portugal, 3814-501
      • Guimaraes, Portugal, 4835-044
      • Lisboa, Portugal, 1069-639
      • Porto, Portugal, 4050-011
  • Reino Unido
      • Abergavenny, Reino Unido, NP7 7EG
      • Aylesbury, Reino Unido, HP21 8AL
      • Blackburn, Reino Unido, BB2 3HH
      • Cambridge, Reino Unido, CB2 2QQ
      • Cannock, Reino Unido, WS11 5XY
      • Cardiff, Reino Unido, CF14 4XW
      • Cheltenham, Reino Unido, GL53 7AN
      • Chertsey, Reino Unido, KT16 0PZ
      • Cosham, Reino Unido, PO6 3LY
      • Derby, Reino Unido, DE1 2QY
      • Durham, Reino Unido, DH15TW
      • Exeter, Reino Unido, EX2 5DW
      • Glasgow, Reino Unido, G12 0XH
      • Harrogate, Reino Unido, HG2 7SX
      • Inverness, Reino Unido, IV2 3UV
      • Lancaster, Reino Unido, LA1 4RP
      • Leeds, Reino Unido, LS7 4SA
      • Lincoln, Reino Unido, LN2 5QY
      • Liverpool, Reino Unido, L9 7AL
      • London, Reino Unido, SE1 9RT
      • London, Reino Unido, SW17 0QT
      • London, Reino Unido, SE5 9PJ
      • Manchester, Reino Unido, M13 9PT
      • Poole, Reino Unido, BH15 2JB
      • Salford, Reino Unido, M6 8HD
      • Solihull, Reino Unido, B91 2JL
      • Southport, Reino Unido, PR8 6PN
      • St Helens, Reino Unido, WA9 3DA
      • Stockport, Reino Unido, SK2 7JE
      • Sunderland, Reino Unido, SR4 7TP
      • Sutton in Ashfield, Reino Unido, NG17 4JL
      • Torquay, Reino Unido, TQ2 7AA
      • Truro, Reino Unido, TR1 3LJ
      • Warrington, Reino Unido, WA5 1QG
      • Wirral, Reino Unido, CH49 5PE
      • Wolverhampton, Reino Unido, DY1 2HQ
      • Worthing, Reino Unido, BN11 2DH
      • Wrightington, Reino Unido, WN6 9EP

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

Rheumatoid arthritis patients who are non-responders or intolerant to a single TNF-inhibitor

Descripción

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

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
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12
Periodo de tiempo: 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
Least Squares Mean Change From Baseline in TJC at Months 6 and 12
Periodo de tiempo: 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
Least Squares Mean Change From Baseline in SJC at Months 6 and 12
Periodo de tiempo: 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
Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12
Periodo de tiempo: 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
Least Squares Mean Change From Baseline in ESR at Months 6 and 12
Periodo de tiempo: 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.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12
Periodo de tiempo: 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.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12
Periodo de tiempo: 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
Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12
Periodo de tiempo: 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.
Baseline, Month 6, and Month 12
Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12
Periodo de tiempo: 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
Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12
Periodo de tiempo: 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.
Baseline, Month 6, and Month 12
Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy
Periodo de tiempo: 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.
Month 6 and Month 12
Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice
Periodo de tiempo: Up to 12 months
Up to 12 months
Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
Periodo de tiempo: 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.
Up to 12 Months
Number of Participants With Reasons for Discontinuation of the First TNFi Therapy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Hoffmann-La Roche

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 junio de 2009

Finalización primaria (Actual)

1 de marzo de 2012

Finalización del estudio (Actual)

1 de marzo de 2012

Fechas de registro del estudio

Enviado por primera vez

13 de marzo de 2012

Primero enviado que cumplió con los criterios de control de calidad

16 de marzo de 2012

Publicado por primera vez (Estimar)

19 de marzo de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de enero de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

28 de noviembre de 2016

Última verificación

1 de noviembre de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MA22401

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. .

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