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An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

12 de janeiro de 2016 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

1225

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Aachen, Alemanha, 52064
      • Bad Aibling, Alemanha, 83043
      • Bad Neuenahr-Ahrweiler, Alemanha, 53474
      • Bayreuth, Alemanha, 95445
      • Berlin, Alemanha, 13055
      • Dresden, Alemanha, 01109
      • Erfurt, Alemanha, 99096
      • Erlangen, Alemanha, 91056
      • Fulda, Alemanha, 36043
      • Hamburg, Alemanha, 22767
      • Hamburg, Alemanha, 22147
      • Heidelberg, Alemanha, 69121
      • Herne, Alemanha, 44652
      • Köln, Alemanha, 50937
      • Ludwigsfelde, Alemanha, 14974
      • München, Alemanha, 81541
      • München, Alemanha, 80639
      • Passau, Alemanha, 94032
      • Rostock, Alemanha, 18059
      • Stuttgart, Alemanha, 70178
      • Traunstein, Alemanha, 83278
      • Wuppertal, Alemanha, 42105
  • Argentina
      • Catamarca Capital, Argentina, 4700
      • Mendoza, Argentina, 5500
      • Mendoza, Argentina, 5501
      • Rosario, Argentina, S2000PBJ
  • Bélgica
      • AYE, Bélgica, 6900
      • Aalst, Bélgica, 9300
      • Assebroek, Bélgica, 8310
      • Bruxelles, Bélgica, 1050
      • Bruxelles, Bélgica, 1000
      • Edegem, Bélgica, 2650
      • Genk, Bélgica, 3600
      • Gent, Bélgica, 9000
      • Godinne, Bélgica, 5530
      • Heusy, Bélgica, 4802
      • Liège, Bélgica, 4000
      • Oostende, Bélgica, 8400
      • Verviers, Bélgica, 4800
      • Westmalle, Bélgica, 2390
  • Colômbia
      • Barranquilla, Colômbia
      • Bogota, Colômbia
      • Bucaramanga, Colômbia
      • Medellin, Colômbia
  • Equador
      • Cuenca, Equador
      • Esmeraldas, Equador, EC080150
      • Guayaquil, Equador, EC090114
      • Portoviejo, Equador
      • Quito, Equador, 005932
      • Quito, Equador, EC170135
      • Quito, Equador, EC170412
  • Espanha
      • Madrid, Espanha, 28006
      • Madrid, Espanha, 28905
      • Madrid, Espanha, 28007
    • Madrid
      • Fuenlabrada, Madrid, Espanha, 28942
      • San Sebastian de los Reyes, Madrid, Espanha, 28702
  • Grécia
      • Athens, Grécia, 11527
      • Athens, Grécia, 155 62
      • Patra, Grécia, 26335
      • Thessaloniki, Grécia, 56429
      • Thessaloniki, Grécia, 544 65
  • Guatemala
      • Ciudad de Guatemala, Guatemala
  • Itália
    • Abruzzo
      • Coppito, Abruzzo, Itália, 67100
      • Pescara, Abruzzo, Itália, 65100
    • Calabria
      • Reggio Calabria, Calabria, Itália, 89133
    • Campania
      • Avellino, Campania, Itália, 83100
      • Napoli, Campania, Itália, 80131
      • Napoli, Campania, Itália, 80144
      • Salerno, Campania, Itália, 84131
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Itália, 33100
    • Lazio
      • Roma, Lazio, Itália, 00133
      • Roma, Lazio, Itália, 00189
    • Liguria
      • Arenzano, Liguria, Itália, 16011
    • Lombardia
      • Brescia, Lombardia, Itália, 25123
      • Legnano, Lombardia, Itália, 20025
      • Milano, Lombardia, Itália, 20157
      • Milano, Lombardia, Itália, 20162
    • Marche
      • Jesi Ancona, Marche, Itália, 60035
    • Molise
      • Agnone, Molise, Itália, 86081
    • Piemonte
      • Torino, Piemonte, Itália, 10126
      • Torino, Piemonte, Itália, 10128
    • Puglia
      • Brindisi, Puglia, Itália, 72100
      • Martina Franca, Puglia, Itália, 74015
      • San Cesario Di Lecce, Puglia, Itália, 73016
    • Sicilia
      • Catania, Sicilia, Itália, 95124
    • Toscana
      • Prato, Toscana, Itália, 59100
    • Umbria
      • Perugia, Umbria, Itália, 06122
  • México
      • Guadalajara, México, 44650
      • Guadalajara, México, 44600
      • Guadalajara, México, 45040
      • Mexicali, México, 21100
      • Mexico Ctiy, México, 07760
  • Panamá
      • Panama City, Panamá, 32400
  • Portugal
      • Almada, Portugal, 2801-951
      • Amadora, Portugal, 2720-276
      • Lisboa, Portugal, 1649-035
      • Lisboa, Portugal, 1069-166
      • Porto, Portugal, 4200-319
      • Porto, Portugal, 4099-001
      • Vila Nova de Gaia, Portugal, 4400-129
  • Reino Unido
      • Barnsley, Reino Unido, S75 2EP
      • Basildon, Reino Unido, SS16 5NL
      • Basingstoke, Reino Unido, RG24 9NA
      • Brighton, Reino Unido, BN2 5BE
      • Cannock, Reino Unido, WS11 5XY
      • Cardiff, Reino Unido, CF14 4XW
      • Chertsey, Reino Unido, KT16 0PZ
      • Crawley, Reino Unido, RH11 7DH
      • Darlington, Reino Unido, DL3 6HX
      • Enfield, Reino Unido, EN2 8JL
      • Grimsby, Reino Unido, DN33 2BA
      • Guildford, Reino Unido, GU2 7XX
      • Ipswich, Reino Unido, IP4 5PD
      • Kettering, Reino Unido, NN16 8UZ
      • Lancaster, Reino Unido, LA1 4RP
      • Leeds, Reino Unido, LS7 4SA
      • Llandudno, Reino Unido, LL30 1LB
      • London, Reino Unido, W6 8RF
      • London, Reino Unido, SW17 0QT
      • London, Reino Unido, SE18 4QH
      • Luton, Reino Unido, LU4 0DZ
      • Maidstone, Reino Unido, ME16 9QQ
      • Margate, Reino Unido, CT9 4AN
      • North Shields, Reino Unido, NE29 8NH
      • Oswestry, Reino Unido, SY10 7AG
      • Plymouth, Reino Unido, PL6 8DH
      • Portsmouth, Reino Unido, PO6 3LY
      • Reading, Reino Unido, RG1 5AN
      • Rhyl, Reino Unido, LL18 5UJ
      • Romford, Reino Unido, RM7 0AG
      • Sheffield, Reino Unido, S10 2JF
      • Stockport, Reino Unido, SK2 7JE
      • Sunderland, Reino Unido, SR4 7TP
      • Swindon, Reino Unido, SN3 6BB
      • Torquay, Reino Unido, TQ2 7AA
      • Warrington, Reino Unido, WA5 1QG
      • Wirral, Reino Unido, CH49 5PE
      • Wolverhampton, Reino Unido, WV10 0QP
      • Wrightington, Reino Unido, WN6 9EP
  • Suíça
      • Aarau, Suíça, 5000
      • Basel, Suíça, 4031
      • Chur, Suíça, 7000
      • St. Gallen, Suíça, 9007
  • Ucrânia
      • Donetsk, Ucrânia, 83045
      • Kharkiv, Ucrânia, 61052
      • Kmelnytskyy, Ucrânia, 29000
      • Kyiv, Ucrânia, 02125
      • Kyiv, Ucrânia, 03151
      • Kyiv, Ucrânia, 1023
      • Odesa, Ucrânia, 65026
      • Uzhgorod, Ucrânia, 88000
      • Zaporizhzhya, Ucrânia, 69600
  • Uruguai
      • Montevideo, Uruguai, 11000
      • Montevideo, Uruguai, 11800

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

Adult patients with rheumatoid arthritis

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Coorte

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
Prazo: Baseline and Week 24
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.
Baseline and Week 24

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
Prazo: Baseline and Week 52
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.
Baseline and Week 52
Mean Change From Baseline in Erythrocyte Sedimentation Rate
Prazo: Baseline, Week 24, Week 52
Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.
Baseline, Week 24, Week 52
Mean Change From Baseline in C-reactive Protein
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52
Mean Change From Baseline in Swollen Joint Count
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52
Mean Change From Baseline in Tender Joint Count
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52
Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52
Mean Change From Baseline in Physician Global Assessment Score
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52
Loss of Efficacy or Development of Intolerance to Biologic Therapy
Prazo: Up to Week 52
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.
Up to Week 52
Proportion of Participants Who Terminated Biologic Treatment
Prazo: Up to Week 52
The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.
Up to Week 52
Reasons for Treatment Discontinuation
Prazo: Up to Week 52
The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.
Up to Week 52
Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period
Prazo: Up to end of treatment
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.
Up to end of treatment
Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy
Prazo: Up to Week 52
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.
Up to Week 52
Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events
Prazo: Up to Week 52
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.
Up to Week 52
Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study
Prazo: Up to Week 52
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.
Up to Week 52
Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52
Mean Change From Baseline in Visual Analogue Scale Pain Score
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52
Shift From Baseline in Morning Stiffness
Prazo: Baseline, Week 24, Week 52
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
Baseline, Week 24, Week 52
Change From Baseline in Patient Global Assessment of Disease Activity
Prazo: Baseline, Week 24, Week 52
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.
Baseline, Week 24, Week 52

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 2012

Conclusão Primária (Real)

1 de fevereiro de 2015

Conclusão do estudo (Real)

1 de fevereiro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

28 de fevereiro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de fevereiro de 2012

Primeira postagem (Estimativa)

5 de março de 2012

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

10 de fevereiro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de janeiro de 2016

Última verificação

1 de janeiro de 2016

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MA27950

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