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

12 gennaio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1225

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Adult patients with rheumatoid arthritis

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Coorte

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2012

Completamento primario (Effettivo)

1 febbraio 2015

Completamento dello studio (Effettivo)

1 febbraio 2015

Date di iscrizione allo studio

Primo inviato

28 febbraio 2012

Primo inviato che soddisfa i criteri di controllo qualità

28 febbraio 2012

Primo Inserito (Stima)

5 marzo 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

10 febbraio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 gennaio 2016

Ultimo verificato

1 gennaio 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MA27950

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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