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Comparing the Effectiveness of a Treat-to-target (T2T) Disease Management Strategy vs. Routine Care (RC) in Adult Patients With Moderate to Severe Rheumatoid Arthritis (RA) Treated With Subcutaneous Abatacept (Orencia - SC) (ABC)

28 gennaio 2019 aggiornato da: Bristol-Myers Squibb

The Abatacept Best Care (ABC) Trial

This is a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to participate in a 12-month extension of their follow-up provided that this is in agreement with the judgment of the treating physician.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Effettivo)

281

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

  • Canada
    • Quebec
      • Westmount, Quebec, Canada, H3Z 1R7
        • Local Institution

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 non probabilistico

Popolazione di studio

Adult patients with active RA defined as a CDAI > 10 for whom the treating physician has made the decision to initiate treatment with SC abatacept according to the approved Canadian product monograph and regional reimbursement criteria will be potentially eligible for inclusion in the study. The decision to treat the patient with SC abatacept must have been reached prior to and independently of considering the patient for study enrollment.

Descrizione

Inclusion Criteria:

  • 18 years of age or older.
  • Active moderate to severe RA, defined as CDAI > 10.
  • The treating physician has made the decision to initiate treatment with SC abatacept in accordance with the Canadian product monograph.
  • Patient has provided a written informed consent and is able to complete the survey requirements.
  • Patient fulfills the reimbursement criteria for treatment with SC abatacept under provincial or private health insurance reimbursement coverage.

Exclusion Criteria:

  • Has received abatacept (SC or IV) prior to the enrolment visit.
  • Has failed more than one prior biologic DMARD therapy
  • Has a history of autoimmune disease or of any joint inflammatory disease other than RA with the exception of concomitant secondary Sjogren's syndrome.
  • Is participating in an ongoing clinical trial and/or has received treatment with an investigational agent within 4 weeks before starting treatment with SC abatacept.
  • Is participating in another industry-sponsored observational study.
  • Patients participating to non-industry related registries or other data collection studies can be included
  • Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of RA treatment.

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
Intervento / Trattamento
T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
Altro: Non interventistico
Non interventistico
RC Patients
RA patients managed with routine care(RC)
Altro: Non interventistico
Non interventistico

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of T2T patients achieving sustained CDAI LDA
Lasso di tempo: Approximately 1 year
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
Approximately 1 year
Number of RC patients achieving sustained CDAI LDA
Lasso di tempo: Approximately 1 year
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
Approximately 1 year

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of patients achieving SDAI remission
Lasso di tempo: Up to 24 months
Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3
Up to 24 months
Mean time for patients to achieve SDAI remission
Lasso di tempo: Up to 24 months
Length of time from treatment initiation SDAI remission
Up to 24 months
Number of patients achieving CDAI remission
Lasso di tempo: Up to 24 months
Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8
Up to 24 months
Mean time for patients to achieve CDAI remission
Lasso di tempo: Up to 24 months
Length of time from treatment initiation CDAI remission
Up to 24 months
Number of patients achieving DAS28-CRP LDA
Lasso di tempo: Up to 24 months
Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2
Up to 24 months
Mean time for patients to achieve DAS28-CRP LDA
Lasso di tempo: Up to 24 months
Length of time from treatment initiation to a DAS28-CRP score of less than 3.2
Up to 24 months
Number of patients achieving DAS28-CRP remission
Lasso di tempo: Up to 24 months
Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6
Up to 24 months
Mean time for patients to achieve DAS28-CRP remission
Lasso di tempo: Up to 24 months
Length of time from treatment initiation to a DAS28-CRP score of less than 2.6
Up to 24 months
Number of patients achieving Boolean remission
Lasso di tempo: Up to 24 months
Boolean remission is defined as TJC28 ≤1 and SJC28 ≤1 and CRP ≤1 mg/dl and PtGA ≤1 (on a 0-10 scale)
Up to 24 months
Mean time for patients to achieve Boolean remission
Lasso di tempo: Up to 24 months
Length of time from treatment initiation to Boolean remission.
Up to 24 months
Number of patients achieving RAPID3 LDA
Lasso di tempo: Up to 24 months
Routine Assessment of Patient Index Data 3 (RAPID3) Low Disease Activity (LDA) is achieved when RAPID3 score is less than or equal to 6.
Up to 24 months
Mean time for patients to achieve RAPID3 LDA
Lasso di tempo: Up to 24 months
Length of time from treatment initiation to a RAPID3 score of less than or equal to 6
Up to 24 months
Number of patients achieving RAPID3 remission
Lasso di tempo: Up to 24 months
Routine Assessment of Patient Index Data 3 (RAPID3) remission is achieved when RAPID3 score is less than or equal to 3.
Up to 24 months
Mean time for patients to achieve RAPID3 remission
Lasso di tempo: Up to 24 months
Length of time from treatment initiation to a RAPID3 score of less than or equal to 3
Up to 24 months
Number of patients achieving MCID in HAQ-DI
Lasso di tempo: Up to 24 months
minimal clinically important difference (MCID; Δ ≥ 0.22, ≥0.25, and ≥0.5) in Health Assessment Questionnaire Disability Index (HAQ-DI)
Up to 24 months
Mean time for patients to achieve MCID in HAQ-DI
Lasso di tempo: Up to 24 months
Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI
Up to 24 months
Number of patients achieving clinically meaningful improvement
Lasso di tempo: Up to 24 months
Number of patients achieving clinically meaningful improvement as measured by a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
Up to 24 months
Mean time for patients to achieve clinically meaningful improvement
Lasso di tempo: Up to 24 months
Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
Up to 24 months
Number of patients achieving patient expectations for treatment of their RA
Lasso di tempo: Up to 24 months
Assessed using simple Visual Analogue Scales (VAS)
Up to 24 months
Change from baseline in DAS28-CRP score
Lasso di tempo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in CDAI score
Lasso di tempo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in SDAI score
Lasso di tempo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in RAPID3 score
Lasso di tempo: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in Tender Joint Count of 28 joints (TJC28) score
Lasso di tempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
Lasso di tempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in HAQ-DI score
Lasso di tempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Work Productivity and Activity Impairment (WPAI) score
Lasso di tempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Patient Pain
Lasso di tempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Patient Fatigue
Lasso di tempo: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Number of patients continuing treatment
Lasso di tempo: At 12 months
Measured by investigator assessment
At 12 months
Number of patients continuing treatment
Lasso di tempo: At 24 months
Measured by investigator assessment
At 24 months
Number of changes to Rheumatoid Arthritis (RA) treatment
Lasso di tempo: Up to 24 months
Measured by investigator assessment
Up to 24 months
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
Lasso di tempo: Up to 12 months
Measured by questionnaire
Up to 12 months
Incidence of treatment-emergent Adverse Events
Lasso di tempo: Up to 24 months
Measured by investigator assessment
Up to 24 months
Time to achieve sustained CDAI LDA
Lasso di tempo: Up to 12 Months
Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
Up to 12 Months

Collaboratori e investigatori

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

Sponsor

Bristol-Myers Squibb

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.

Collegamenti utili

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 (Effettivo)

31 ottobre 2011

Completamento primario (Effettivo)

31 ottobre 2018

Completamento dello studio (Effettivo)

31 ottobre 2018

Date di iscrizione allo studio

Primo inviato

5 settembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

5 settembre 2017

Primo Inserito (Effettivo)

6 settembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 gennaio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 gennaio 2019

Ultimo verificato

1 gennaio 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IM101-331

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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