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)

Rheumatoid Arthritis Clinical Trial

— ABC  

Official title:

The Abatacept Best Care (ABC) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274141
• Other study ID #: IM101-331
• Status: Completed
• Start date: October 31, 2011
• Est. completion date: October 31, 2018

Study information

• Verified date: January 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
Canada	Local Institution	Westmount	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Mean time for patients to achieve SDAI remission	Length of time from treatment initiation SDAI remission	Up to 24 months
Secondary	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
Secondary	Mean time for patients to achieve CDAI remission	Length of time from treatment initiation CDAI remission	Up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean time for patients to achieve Boolean remission	Length of time from treatment initiation to Boolean remission.	Up to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients achieving MCID in HAQ-DI	minimal clinically important difference (MCID; ? = 0.22, =0.25, and =0.5) in Health Assessment Questionnaire Disability Index (HAQ-DI)	Up to 24 months
Secondary	Mean time for patients to achieve MCID in HAQ-DI	Length of time from treatment initiation to a ? = 0.22, =0.25, and =0.5 in HAQ-DI	Up to 24 months
Secondary	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
Secondary	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
Secondary	Number of patients achieving patient expectations for treatment of their RA	Assessed using simple Visual Analogue Scales (VAS)	Up to 24 months
Secondary	Change from baseline in DAS28-CRP score	Measured by investigator assessment	Baseline up to 24 months
Secondary	Change from baseline in CDAI score	Measured by investigator assessment	Baseline up to 24 months
Secondary	Change from baseline in SDAI score	Measured by investigator assessment	Baseline up to 24 months
Secondary	Change from baseline in RAPID3 score	Measured by investigator assessment	Baseline up to 24 months
Secondary	Change from baseline in Tender Joint Count of 28 joints (TJC28) score	Measured by patient assessment	Baseline up to 24 months
Secondary	Change from baseline in Swollen Joint Count of 28 joints (SJC28) score	Measured by patient assessment	Baseline up to 24 months
Secondary	Change from baseline in HAQ-DI score	Measured by patient assessment	Baseline up to 24 months
Secondary	Change from baseline in Work Productivity and Activity Impairment (WPAI) score	Measured by patient assessment	Baseline up to 24 months
Secondary	Change from baseline in Patient Pain	Measured by patient assessment	Baseline up to 24 months
Secondary	Change from baseline in Patient Fatigue	Measured by patient assessment	Baseline up to 24 months
Secondary	Number of patients continuing treatment	Measured by investigator assessment	At 12 months
Secondary	Number of patients continuing treatment	Measured by investigator assessment	At 24 months
Secondary	Number of changes to Rheumatoid Arthritis (RA) treatment	Measured by investigator assessment	Up to 24 months
Secondary	Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment	Measured by questionnaire	Up to 12 months
Secondary	Incidence of treatment-emergent Adverse Events	Measured by investigator assessment	Up to 24 months
Secondary	Time to achieve sustained CDAI LDA	Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)	Up to 12 Months

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