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

Bristol-Myers Squibb

Overview

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

* 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

Study Type

OBSERVATIONAL

Conditions

Rheumatoid Arthritis

Interventions

OrenciaDRUG

No Intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 5 Years

Number of patients disease progression with prior improvement

Time frame: Up to 5 Years

Number of patients disease progression with no prior improvement

Time frame: Up to 5 Years

Number of patients with modification of Orencia administration condition

Time frame: Up to 5 Years

Number of patients discontinued and switched from Orencia

Time frame: Up to 5 Years

Data from ClinicalTrials.gov

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