Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings

Study Overview
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Brief Summary
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The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.

Official Title
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Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: ORENCIA Subcutaneous Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification 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: Past history of hypersensitivity to the components of the abatacept preparation Disease complications from a comorbidity Active infectious disease Been judged by the investigator or the co-investigator as being inappropriate Other protocol defined inclusion/exclusion criteria could apply

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 |
| --- | --- |
| ORENCIA with Exposure<br>ORENCIA with Exposure | Biological: ORENCIA Subcutaneous Injection<br> <br> * Other names: Abatacept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of achievement in low disease activity by simplified disease activity index (SDAI). |  | 52 Weeks | 
| Change in the percentage of disease activity category by simplified disease activity index(SDAI) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in the percentage of disease activity category by clinical disease activity index(CDAI) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in simplified disease activity index(SDAI) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in clinical disease activity index(CDAI) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in Anti-citrullinated protein antibodies (ACPA) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in Rheumatoid factors (RF) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Survival rate |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Hospitalization rate |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Number of occurrences of rheumatoid arthritis related surgery |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Persistence rate of Abatacept treatment |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Reasons for discontinuation of Abatacept treatment |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in Japanese Health Assessment Questionnaire |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in European Quality of Life 5 Dimension Questionnaire |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in Pain visual analog scale |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in General visual analog scale |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months | 
| Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56) |  | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |