Rheumatoid Arthritis
Conditions
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.
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mean time for patients to achieve CDAI remission | Up to 24 months | Length of time from treatment initiation CDAI remission |
| 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 |
| 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 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 |
| 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. |
| 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 RAPID3 LDA | Up to 24 months | Length of time from treatment initiation to a RAPID3 score of less than or equal to 6 |
| 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. |
| 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) |
| 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 |
| 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 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 |
| 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 SDAI score | Baseline up to 24 months | Measured by investigator assessment |
| Change from baseline in RAPID3 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 Swollen Joint Count of 28 joints (SJC28) score | Baseline up to 24 months | Measured by patient assessment |
| Change from baseline in HAQ-DI score | Baseline up to 24 months | Measured by patient assessment |
| Change from baseline in Work Productivity and Activity Impairment (WPAI) 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 |
| Change from baseline in Patient Fatigue | Baseline up to 24 months | Measured by patient assessment |
| Number of patients continuing treatment | At 12 months | Measured by investigator assessment |
| 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 |
| Incidence of treatment-emergent Adverse Events | Up to 24 months | Measured by investigator 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 patient expectations for treatment of their RA | Up to 24 months | Assessed using simple Visual Analogue Scales (VAS) |
| Mean time for patients to achieve SDAI remission | Up to 24 months | Length of time from treatment initiation SDAI remission |
Countries
Canada
Outcome results
None listed