Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan
NCT ID: NCT02335606
Last Updated: 2022-01-21
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
213 participants
OBSERVATIONAL
2014-08-06
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients treating with Abatacept
Patients who are abatacept naive and are initiating abatacept treatment (either IV or SC) including those that are switching from another bDMARD, as well as, patients currently being treated with IV or SC abatacept some of which may have switched from IV abatacept to SC abatacept
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Who give informed consent
* Confirmed diagnosis of RA (as defined by American College of Rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
* Who self-pay or who are reimbursed by BNHI for abatacept treatment
* With latent TB or who are receiving anti-TB treatment (INH 300 mg, QD) 1 month prior to using abatacept and continuously up to a total of 9 months Willing to follow Taiwan Risk Management Plan guidelines as required by Taiwan health authorities
* Are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy
Exclusion Criteria
* With active TB
* HBsAg (+)and/or Anti-HCV(+) and/or HBV DNA(+)
* Have cancer (patients who were treated and have no sign of cancer for \> 10 years can be included)
* Are allergic to abatacept
* Enrolled in other RA clinical studies
20 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
Taipei, , Taiwan
Countries
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Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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IM101-440
Identifier Type: -
Identifier Source: org_study_id
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