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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 januari 2019 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Werkelijk)
281
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Quebec
-
Westmount, Quebec, Canada, H3Z 1R7
- Local Institution
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
|
Niet-interventioneel
|
RC Patients
RA patients managed with routine care(RC)
|
Niet-interventioneel
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of T2T patients achieving sustained CDAI LDA
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of patients achieving SDAI remission
Tijdsspanne: 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
Tijdsspanne: Up to 24 months
|
Length of time from treatment initiation SDAI remission
|
Up to 24 months
|
Number of patients achieving CDAI remission
Tijdsspanne: 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
Tijdsspanne: Up to 24 months
|
Length of time from treatment initiation CDAI remission
|
Up to 24 months
|
Number of patients achieving DAS28-CRP LDA
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 24 months
|
Length of time from treatment initiation to Boolean remission.
|
Up to 24 months
|
Number of patients achieving RAPID3 LDA
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 24 months
|
Assessed using simple Visual Analogue Scales (VAS)
|
Up to 24 months
|
Change from baseline in DAS28-CRP score
Tijdsspanne: Baseline up to 24 months
|
Measured by investigator assessment
|
Baseline up to 24 months
|
Change from baseline in CDAI score
Tijdsspanne: Baseline up to 24 months
|
Measured by investigator assessment
|
Baseline up to 24 months
|
Change from baseline in SDAI score
Tijdsspanne: Baseline up to 24 months
|
Measured by investigator assessment
|
Baseline up to 24 months
|
Change from baseline in RAPID3 score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
Change from baseline in HAQ-DI score
Tijdsspanne: 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
Tijdsspanne: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
Change from baseline in Patient Pain
Tijdsspanne: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
Change from baseline in Patient Fatigue
Tijdsspanne: Baseline up to 24 months
|
Measured by patient assessment
|
Baseline up to 24 months
|
Number of patients continuing treatment
Tijdsspanne: At 12 months
|
Measured by investigator assessment
|
At 12 months
|
Number of patients continuing treatment
Tijdsspanne: At 24 months
|
Measured by investigator assessment
|
At 24 months
|
Number of changes to Rheumatoid Arthritis (RA) treatment
Tijdsspanne: Up to 24 months
|
Measured by investigator assessment
|
Up to 24 months
|
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
Tijdsspanne: Up to 12 months
|
Measured by questionnaire
|
Up to 12 months
|
Incidence of treatment-emergent Adverse Events
Tijdsspanne: Up to 24 months
|
Measured by investigator assessment
|
Up to 24 months
|
Time to achieve sustained CDAI LDA
Tijdsspanne: Up to 12 Months
|
Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
|
Up to 12 Months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 oktober 2011
Primaire voltooiing (Werkelijk)
31 oktober 2018
Studie voltooiing (Werkelijk)
31 oktober 2018
Studieregistratiedata
Eerst ingediend
5 september 2017
Eerst ingediend dat voldeed aan de QC-criteria
5 september 2017
Eerst geplaatst (Werkelijk)
6 september 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 januari 2019
Laatste update ingediend die voldeed aan QC-criteria
28 januari 2019
Laatst geverifieerd
1 januari 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IM101-331
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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