An observational study in Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Bristol-Myers Squibb · Observational
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.
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.
Exclusion Criteria:
RA patients managed with a treat-to-target (T2T) strategy
Other: Non-Interventional
RA patients managed with routine care(RC)
Other: Non-Interventional
Non-Interventional
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
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
Time frame: Baseline up to 24 months
Change from baseline in CDAI score
Measured by investigator assessment
Time frame: Baseline up to 24 months
Change from baseline in SDAI score
Measured by investigator assessment
Time frame: Baseline up to 24 months
Change from baseline in RAPID3 score
Measured by investigator assessment
Time frame: Baseline up to 24 months
Change from baseline in Tender Joint Count of 28 joints (TJC28) score
Measured by patient assessment
Time frame: Baseline up to 24 months
Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
Measured by patient assessment
Time frame: Baseline up to 24 months
Change from baseline in HAQ-DI score
Measured by patient assessment
Time frame: Baseline up to 24 months
Change from baseline in Work Productivity and Activity Impairment (WPAI) score
Measured by patient assessment
Time frame: Baseline up to 24 months
Change from baseline in Patient Pain
Measured by patient assessment
Time frame: Baseline up to 24 months
Change from baseline in Patient Fatigue
Measured by patient assessment
Time frame: Baseline up to 24 months
Number of patients continuing treatment
Measured by investigator assessment
Time frame: At 12 months
Number of patients continuing treatment
Measured by investigator assessment
Time frame: At 24 months
Number of changes to Rheumatoid Arthritis (RA) treatment
Measured by investigator assessment
Time frame: Up to 24 months
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
Measured by questionnaire
Time frame: Up to 12 months
Incidence of treatment-emergent Adverse Events
Measured by investigator assessment
Time frame: Up to 24 months
Time to achieve sustained CDAI LDA
Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
Time frame: Up to 12 Months
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb