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Trial record 73 of 279 for:    Best Disease

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) (ABC)

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ClinicalTrials.gov Identifier: NCT03274141
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Non-Interventional

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Study Type : Observational
Actual Enrollment : 281 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Abatacept Best Care (ABC) Trial
Actual Study Start Date : October 31, 2011
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
Other: Non-Interventional
Non-Interventional

RC Patients
RA patients managed with routine care(RC)
Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274141


Locations
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Canada, Quebec
Local Institution
Westmount, Quebec, Canada, H3Z 1R7
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03274141     History of Changes
Other Study ID Numbers: IM101-331
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arthritis
Arthritis, Rheumatoid
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents