Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan

Study Overview
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Brief Summary
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Abatacept Registry in Taiwan

Official Title
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Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: ≥ 20 years of age 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: Pregnant or breast feeding 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treating with Abatacept<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan. | Treatment retention rate is defined as the proportion of subjects who use abatacept for 24 months | approximately 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients |  | at 6, 9, 12, 18, and 24months after study participation | 
| The time to treatment discontinuation in RA patients treated with abatacept | Treatment discontinuation is defined as patients who cease treatment for > 8 weeks | at 6, 9, 12, 18, and 24months after study participation | 
| The proportion of patients achieving DAS28 ≤ 2.6, 2.6 < DAS28 ≤ 3.2, 3.2 < DAS28 ≤ 5.1, DAS> 5.1 at 6, 9, 12, 18, and 24months |  | at 6, 9, 12, 18, and 24months after study participation | 
| The major reason for treatment discontinuation (eg, lack of efficacy, severe adverse drug reactions, switch from abatacept to another RA medication, financial issues, etc) at 6, 9, 12, 18, and 24 months |  | at 6, 9, 12, 18, and 24months after study participation | 
| The demographic, clinical presentation, and disease management a composite measure of RA patients who are using abatacept (either formulation) or are abatacept naïve at Month 6, 9, 12, 18, and 24 |  | at 6, 9, 12, 18, and 24months after study participation |