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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 janvier 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

281

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
Autre: Non interventionnel
Non interventionnel
RC Patients
RA patients managed with routine care(RC)
Autre: Non interventionnel
Non interventionnel

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of T2T patients achieving sustained CDAI LDA
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of patients achieving SDAI remission
Délai: 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
Délai: Up to 24 months
Length of time from treatment initiation SDAI remission
Up to 24 months
Number of patients achieving CDAI remission
Délai: 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
Délai: Up to 24 months
Length of time from treatment initiation CDAI remission
Up to 24 months
Number of patients achieving DAS28-CRP LDA
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 24 months
Length of time from treatment initiation to Boolean remission.
Up to 24 months
Number of patients achieving RAPID3 LDA
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Up to 24 months
Assessed using simple Visual Analogue Scales (VAS)
Up to 24 months
Change from baseline in DAS28-CRP score
Délai: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in CDAI score
Délai: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in SDAI score
Délai: Baseline up to 24 months
Measured by investigator assessment
Baseline up to 24 months
Change from baseline in RAPID3 score
Délai: 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
Délai: 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
Délai: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in HAQ-DI score
Délai: 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
Délai: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Patient Pain
Délai: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Change from baseline in Patient Fatigue
Délai: Baseline up to 24 months
Measured by patient assessment
Baseline up to 24 months
Number of patients continuing treatment
Délai: At 12 months
Measured by investigator assessment
At 12 months
Number of patients continuing treatment
Délai: At 24 months
Measured by investigator assessment
At 24 months
Number of changes to Rheumatoid Arthritis (RA) treatment
Délai: Up to 24 months
Measured by investigator assessment
Up to 24 months
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
Délai: Up to 12 months
Measured by questionnaire
Up to 12 months
Incidence of treatment-emergent Adverse Events
Délai: Up to 24 months
Measured by investigator assessment
Up to 24 months
Time to achieve sustained CDAI LDA
Délai: Up to 12 Months
Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
Up to 12 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bristol-Myers Squibb

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 octobre 2011

Achèvement primaire (Réel)

31 octobre 2018

Achèvement de l'étude (Réel)

31 octobre 2018

Dates d'inscription aux études

Première soumission

5 septembre 2017

Première soumission répondant aux critères de contrôle qualité

5 septembre 2017

Première publication (Réel)

6 septembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 janvier 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 janvier 2019

Dernière vérification

1 janvier 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IM101-331

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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