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)

Bristol-Myers Squibb281 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

281

Conditions

Rheumatoid Arthritis

Interventions

Non-InterventionalOTHER

Non-Interventional

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Approximately 1 year

Secondary Outcomes

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

Time frame: Up to 24 months

Mean time for patients to achieve SDAI remission

Length of time from treatment initiation SDAI remission

Time frame: 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

Time frame: Up to 24 months

Mean time for patients to achieve CDAI remission

Length of time from treatment initiation CDAI remission

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: Up to 24 months

Mean time for patients to achieve Boolean remission

Length of time from treatment initiation to Boolean remission.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 24 months

Number of patients achieving patient expectations for treatment of their RA

Assessed using simple Visual Analogue Scales (VAS)

Time frame: Up to 24 months

Change from baseline in DAS28-CRP score

Measured by investigator assessment