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)
NCT ID: NCT03274141
Last Updated: 2019-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
281 participants
OBSERVATIONAL
2011-10-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
Non-Interventional
Non-Interventional
RC Patients
RA patients managed with routine care(RC)
Non-Interventional
Non-Interventional
Interventions
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Non-Interventional
Non-Interventional
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Westmount, Quebec, Canada
Countries
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References
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Bessette L, Haraoui B, Rampakakis E, Dembowy J, Trepanier MO, Pope J. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther. 2023 Sep 28;25(1):183. doi: 10.1186/s13075-023-03151-2.
Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM101-331
Identifier Type: -
Identifier Source: org_study_id
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