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)

Study Overview
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Brief Summary
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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.

Official Title
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The Abatacept Best Care (ABC) Trial

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2T Patients<br>RA patients managed with a treat-to-target (T2T) strategy | Other: Non-Interventional<br>* Non-Interventional<br>|
| RC Patients<br>RA patients managed with routine care(RC) | Other: Non-Interventional<br>* Non-Interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of T2T patients achieving sustained CDAI LDA | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients achieving SDAI remission | 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 | Length of time from treatment initiation SDAI remission | Up to 24 months | 
| Number of patients achieving CDAI remission | 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 | Length of time from treatment initiation CDAI remission | Up to 24 months | 
| Number of patients achieving DAS28-CRP LDA | 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 | 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 | 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 | 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 | 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 | Length of time from treatment initiation to Boolean remission. | Up to 24 months | 
| Number of patients achieving RAPID3 LDA | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Assessed using simple Visual Analogue Scales (VAS) | Up to 24 months | 
| Change from baseline in DAS28-CRP score | Measured by investigator assessment | Baseline up to 24 months | 
| Change from baseline in CDAI score | Measured by investigator assessment | Baseline up to 24 months | 
| Change from baseline in SDAI score | Measured by investigator assessment | Baseline up to 24 months | 
| Change from baseline in RAPID3 score | Measured by investigator assessment | Baseline up to 24 months | 
| Change from baseline in Tender Joint Count of 28 joints (TJC28) score | Measured by patient assessment | Baseline up to 24 months | 
| Change from baseline in Swollen Joint Count of 28 joints (SJC28) score | Measured by patient assessment | Baseline up to 24 months | 
| Change from baseline in HAQ-DI score | Measured by patient assessment | Baseline up to 24 months | 
| Change from baseline in Work Productivity and Activity Impairment (WPAI) score | Measured by patient assessment | Baseline up to 24 months | 
| Change from baseline in Patient Pain | Measured by patient assessment | Baseline up to 24 months | 
| Change from baseline in Patient Fatigue | Measured by patient assessment | Baseline up to 24 months | 
| Number of patients continuing treatment | Measured by investigator assessment | At 12 months | 
| Number of patients continuing treatment | Measured by investigator assessment | At 24 months | 
| Number of changes to Rheumatoid Arthritis (RA) treatment | Measured by investigator assessment | Up to 24 months | 
| Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment | Measured by questionnaire | Up to 12 months | 
| Incidence of treatment-emergent Adverse Events | Measured by investigator assessment | Up to 24 months | 
| Time to achieve sustained CDAI LDA | Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA) | Up to 12 Months |