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)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Non-Interventional

• Study Type: Observational
• Enrollment (Actual): 281

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T2T Patients; RA patients managed with a treat-to-target (T2T) strategy	Other: Non-Interventional; Non-Interventional
RC Patients; RA patients managed with routine care(RC)	Other: Non-Interventional; Non-Interventional

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2011
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: IM101-331