Clinical trial NCT03274141: 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)
Official title: The Abatacept Best Care (ABC) Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-09-06
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of T2T patients achieving sustained CDAI LDA
timeFrame: Approximately 1 year
measure: Number of RC patients achieving sustained CDAI LDA
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Number of patients achieving SDAI remission
timeFrame: Up to 24 months
measure: Mean time for patients to achieve SDAI remission
timeFrame: Up to 24 months
measure: Number of patients achieving CDAI remission
timeFrame: Up to 24 months
measure: Mean time for patients to achieve CDAI remission
timeFrame: Up to 24 months
measure: Number of patients achieving DAS28-CRP LDA
timeFrame: Up to 24 months
measure: Mean time for patients to achieve DAS28-CRP LDA
timeFrame: Up to 24 months
measure: Number of patients achieving DAS28-CRP remission
timeFrame: Up to 24 months
measure: Mean time for patients to achieve DAS28-CRP remission
timeFrame: Up to 24 months
measure: Number of patients achieving Boolean remission
timeFrame: Up to 24 months
measure: Mean time for patients to achieve Boolean remission
timeFrame: Up to 24 months
measure: Number of patients achieving RAPID3 LDA
timeFrame: Up to 24 months
measure: Mean time for patients to achieve RAPID3 LDA
timeFrame: Up to 24 months
measure: Number of patients achieving RAPID3 remission
timeFrame: Up to 24 months
measure: Mean time for patients to achieve RAPID3 remission
timeFrame: Up to 24 months
measure: Number of patients achieving MCID in HAQ-DI
timeFrame: Up to 24 months
measure: Mean time for patients to achieve MCID in HAQ-DI
timeFrame: Up to 24 months
measure: Number of patients achieving clinically meaningful improvement
timeFrame: Up to 24 months
measure: Mean time for patients to achieve clinically meaningful improvement
timeFrame: Up to 24 months
measure: Number of patients achieving patient expectations for treatment of their RA
timeFrame: Up to 24 months
measure: Change from baseline in DAS28-CRP score
timeFrame: Baseline up to 24 months
measure: Change from baseline in CDAI score
timeFrame: Baseline up to 24 months
measure: Change from baseline in SDAI score
timeFrame: Baseline up to 24 months
measure: Change from baseline in RAPID3 score
timeFrame: Baseline up to 24 months
measure: Change from baseline in Tender Joint Count of 28 joints (TJC28) score
timeFrame: Baseline up to 24 months
measure: Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
timeFrame: Baseline up to 24 months
measure: Change from baseline in HAQ-DI score
timeFrame: Baseline up to 24 months
measure: Change from baseline in Work Productivity and Activity Impairment (WPAI) score
timeFrame: Baseline up to 24 months
measure: Change from baseline in Patient Pain
timeFrame: Baseline up to 24 months
measure: Change from baseline in Patient Fatigue
timeFrame: Baseline up to 24 months
measure: Number of patients continuing treatment
timeFrame: At 12 months
measure: Number of patients continuing treatment
timeFrame: At 24 months
measure: Number of changes to Rheumatoid Arthritis (RA) treatment
timeFrame: Up to 24 months
measure: Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
timeFrame: Up to 12 months
measure: Incidence of treatment-emergent Adverse Events
timeFrame: Up to 24 months
measure: Time to achieve sustained CDAI LDA
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Westmount
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: