Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study

Study Overview
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Brief Summary
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Database analysis: To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA) To describe joint population of Orencia To assess the impact of the treatment on health status of the treated population as assessed by morbid-mortality criteria To describe therapeutic strategies and use of health services

Detailed Description
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Observational Model: Historic cohort generated from Société Française de Rhumatologie's (SFR) Orencia and Rheumatoid Arthritis (ORA) registry Sampling Method: all physicians and sites taking in charge RA patients received an invitation mailing to participate to ORA Minimum Age: 18 years old at Orencia initiation

Official Title
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Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Orencia


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: Adult outpatients, male or female aged ≥ 18 years old Diagnosed with a rheumatoid arthritis according to ACR criteria Treated with Orencia according to usual practice conditions from June 1st 2007 Agreeing to participate Exclusion Criteria: Patients treated by Orencia in the context of clinical trials

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| RA patients treated by Orencia<br>RA patients treated by Orencia according to usual practice from June 1st 2007 | Drug: Orencia<br>* No Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with first clinically significant Disease Activity Score (DAS) change | Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≥ 1.2 DAS28 will be measured every 6 months during 5 years | Up to 5 Years | 
| Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria] | EULAR response will be measured every 6 months during 5 years | Up to 5 Years | 
| Number of patients with first Low Disease Activity State (LDAS) | Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≤ 3.2 DAS28 will be measured every 6 months during 5 years | Up to 5 Years | 
| Number of patients with first Remission state | Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation <2.6 DAS28 will be measured every 6 months during 5 years | Up to 5 Years | 
| Number of patients disease progression with prior improvement |  | Up to 5 Years | 
| Number of patients disease progression with no prior improvement |  | Up to 5 Years | 
| Number of patients with modification of Orencia administration condition |  | Up to 5 Years | 
| Number of patients discontinued and switched from Orencia |  | Up to 5 Years | 
| Incidence rate of any type of Adverse events related to Orencia |  | Up to 5 Years | 
| Number of patients with specific predefined events | Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death | Up to 5 Years | 
| Response over the time will be assessed over 5 years on EULAR response, LDAS |  | Up to 5 years |