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)
- Conditions
- Rheumatoid Arthritis
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT03274141
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RC Patients Non-Interventional RA patients managed with routine care(RC) T2T Patients Non-Interventional RA patients managed with a treat-to-target (T2T) strategy
- Primary Outcome Measures
Name Time Method Number of T2T patients achieving sustained CDAI LDA 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.
Number of RC patients achieving sustained CDAI LDA 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.
- Secondary Outcome Measures
Name Time Method Change from baseline in SDAI score Baseline up to 24 months Measured by investigator assessment
Change from baseline in Tender Joint Count of 28 joints (TJC28) score Baseline up to 24 months Measured by patient assessment
Change from baseline in Patient Pain Baseline up to 24 months Measured by patient assessment
Number of patients achieving DAS28-CRP LDA Up to 24 months Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2
Number of changes to Rheumatoid Arthritis (RA) treatment Up to 24 months Measured by investigator assessment
Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment Up to 12 months Measured by questionnaire
Number of patients achieving SDAI remission Up to 24 months Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3
Mean time for patients to achieve SDAI remission Up to 24 months Length of time from treatment initiation SDAI remission
Mean time for patients to achieve CDAI remission Up to 24 months Length of time from treatment initiation CDAI remission
Number of patients achieving RAPID3 remission 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.
Change from baseline in DAS28-CRP score Baseline up to 24 months Measured by investigator assessment
Change from baseline in CDAI score Baseline up to 24 months Measured by investigator assessment
Change from baseline in Work Productivity and Activity Impairment (WPAI) score Baseline up to 24 months Measured by patient assessment
Incidence of treatment-emergent Adverse Events Up to 24 months Measured by investigator assessment
Mean time for patients to achieve DAS28-CRP LDA Up to 24 months Length of time from treatment initiation to a DAS28-CRP score of less than 3.2
Number of patients achieving RAPID3 LDA 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.
Mean time for patients to achieve clinically meaningful improvement Up to 24 months Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
Number of patients achieving patient expectations for treatment of their RA Up to 24 months Assessed using simple Visual Analogue Scales (VAS)
Number of patients achieving CDAI remission Up to 24 months Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8
Number of patients achieving Boolean remission 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)
Mean time for patients to achieve Boolean remission Up to 24 months Length of time from treatment initiation to Boolean remission.
Mean time for patients to achieve RAPID3 remission Up to 24 months Length of time from treatment initiation to a RAPID3 score of less than or equal to 3
Number of patients achieving MCID in HAQ-DI 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)
Change from baseline in HAQ-DI score Baseline up to 24 months Measured by patient assessment
Change from baseline in Patient Fatigue Baseline up to 24 months Measured by patient assessment
Time to achieve sustained CDAI LDA Up to 12 Months Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
Number of patients achieving DAS28-CRP remission Up to 24 months Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6
Mean time for patients to achieve DAS28-CRP remission Up to 24 months Length of time from treatment initiation to a DAS28-CRP score of less than 2.6
Mean time for patients to achieve RAPID3 LDA Up to 24 months Length of time from treatment initiation to a RAPID3 score of less than or equal to 6
Mean time for patients to achieve MCID in HAQ-DI Up to 24 months Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI
Number of patients achieving clinically meaningful improvement 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
Change from baseline in RAPID3 score Baseline up to 24 months Measured by investigator assessment
Change from baseline in Swollen Joint Count of 28 joints (SJC28) score Baseline up to 24 months Measured by patient assessment
Number of patients continuing treatment At 24 months Measured by investigator assessment
Trial Locations
- Locations (1)
Local Institution
🇨🇦Westmount, Quebec, Canada