Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
NCT ID: NCT02758769
Last Updated: 2025-06-22
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
303 participants
OBSERVATIONAL
2016-06-07
2023-11-15
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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ORENCIA with Exposure
ORENCIA with Exposure
ORENCIA Subcutaneous Injection
Interventions
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ORENCIA Subcutaneous Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with RA with a moderate disease activity (SDAI: \> 11 and 26)
* Biologic-naive patients with treatment history csDMARDs
* Patients who meet the following criteria by hematological examination:
* Peripheral white blood cell count: 4,000/mm3
* Peripheral lymphocyte count: 1,000/mm3
* Blood β-D-glucan negative
* Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study
* Patients initiated with abatacept at per their physician's therapeutic decision
Exclusion Criteria
* Disease complications from a comorbidity
* Active infectious disease
* Been judged by the investigator or the co-investigator as being inappropriate
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
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 - 0001
Minato-ku, Tokyo, Japan
Local Institution
Minato-ku, Tokyo, Japan
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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IM101-574
Identifier Type: -
Identifier Source: org_study_id
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