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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. januar 2019 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

281

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
Annen: Ikke-intervensjonell
Ikke-intervensjonell
RC Patients
RA patients managed with routine care(RC)
Annen: Ikke-intervensjonell
Ikke-intervensjonell

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of T2T patients achieving sustained CDAI LDA
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Publikasjoner og nyttige lenker

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Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. oktober 2011

Primær fullføring (Faktiske)

31. oktober 2018

Studiet fullført (Faktiske)

31. oktober 2018

Datoer for studieregistrering

Først innsendt

5. september 2017

Først innsendt som oppfylte QC-kriteriene

5. september 2017

Først lagt ut (Faktiske)

6. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IM101-331

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