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Completed

NCT Number: 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)

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Westmount, Quebec, H3Z 1R7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

  1. Number of T2T patients achieving sustained CDAI LDA

    Time frame: 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.

  2. Number of RC patients achieving sustained CDAI LDA

    Time frame: 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 outcomes

  1. Number of patients achieving SDAI remission

    Time frame: Up to 24 months

    Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3

  2. Mean time for patients to achieve SDAI remission

    Time frame: Up to 24 months

    Length of time from treatment initiation SDAI remission

  3. Number of patients achieving CDAI remission

    Time frame: Up to 24 months

    Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8

  4. Mean time for patients to achieve CDAI remission

    Time frame: Up to 24 months

    Length of time from treatment initiation CDAI remission

  5. Number of patients achieving DAS28-CRP LDA

    Time frame: Up to 24 months

    Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2

  6. Mean time for patients to achieve DAS28-CRP LDA

    Time frame: Up to 24 months

    Length of time from treatment initiation to a DAS28-CRP score of less than 3.2

  7. Number of patients achieving DAS28-CRP remission

    Time frame: Up to 24 months

    Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6

  8. Mean time for patients to achieve DAS28-CRP remission

    Time frame: Up to 24 months

    Length of time from treatment initiation to a DAS28-CRP score of less than 2.6

  9. Number of patients achieving Boolean remission

    Time frame: 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)

  10. Mean time for patients to achieve Boolean remission

    Time frame: Up to 24 months

    Length of time from treatment initiation to Boolean remission.

  11. Number of patients achieving RAPID3 LDA

    Time frame: 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.

  12. Mean time for patients to achieve RAPID3 LDA

    Time frame: Up to 24 months

    Length of time from treatment initiation to a RAPID3 score of less than or equal to 6

  13. Number of patients achieving RAPID3 remission

    Time frame: 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.

  14. Mean time for patients to achieve RAPID3 remission

    Time frame: Up to 24 months

    Length of time from treatment initiation to a RAPID3 score of less than or equal to 3

  15. Number of patients achieving MCID in HAQ-DI

    Time frame: 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)

  16. Mean time for patients to achieve MCID in HAQ-DI

    Time frame: Up to 24 months

    Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI

  17. Number of patients achieving clinically meaningful improvement

    Time frame: 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

  18. Mean time for patients to achieve clinically meaningful improvement

    Time frame: Up to 24 months

    Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2

  19. Number of patients achieving patient expectations for treatment of their RA

    Time frame: Up to 24 months

    Assessed using simple Visual Analogue Scales (VAS)

  20. Change from baseline in DAS28-CRP score

    Time frame: Baseline up to 24 months

    Measured by investigator assessment

  21. Change from baseline in CDAI score

    Time frame: Baseline up to 24 months

    Measured by investigator assessment

  22. Change from baseline in SDAI score

    Time frame: Baseline up to 24 months

    Measured by investigator assessment

  23. Change from baseline in RAPID3 score

    Time frame: Baseline up to 24 months

    Measured by investigator assessment

  24. Change from baseline in Tender Joint Count of 28 joints (TJC28) score

    Time frame: Baseline up to 24 months

    Measured by patient assessment

  25. Change from baseline in Swollen Joint Count of 28 joints (SJC28) score

    Time frame: Baseline up to 24 months

    Measured by patient assessment

  26. Change from baseline in HAQ-DI score

    Time frame: Baseline up to 24 months

    Measured by patient assessment

  27. Change from baseline in Work Productivity and Activity Impairment (WPAI) score

    Time frame: Baseline up to 24 months

    Measured by patient assessment

  28. Change from baseline in Patient Pain

    Time frame: Baseline up to 24 months

    Measured by patient assessment

  29. Change from baseline in Patient Fatigue

    Time frame: Baseline up to 24 months

    Measured by patient assessment

  30. Number of patients continuing treatment

    Time frame: At 12 months

    Measured by investigator assessment

  31. Number of patients continuing treatment

    Time frame: At 24 months

    Measured by investigator assessment

  32. Number of changes to Rheumatoid Arthritis (RA) treatment

    Time frame: Up to 24 months

    Measured by investigator assessment

  33. Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment

    Time frame: Up to 12 months

    Measured by questionnaire

  34. Incidence of treatment-emergent Adverse Events

    Time frame: Up to 24 months

    Measured by investigator assessment

  35. Time to achieve sustained CDAI LDA

    Time frame: Up to 12 Months

    Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

The Abatacept Best Care (ABC) Trial

Acronym: ABC

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2017
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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