Rheumatoid Arthritis
Conditions
Brief summary
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
* 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
Interventions
DRUGOrencia
No Intervention
Sponsors
Bristol-Myers Squibb
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with first clinically significant Disease Activity Score (DAS) change | Up to 5 Years | 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 |
| Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria] | Up to 5 Years | EULAR response will be measured every 6 months during 5 years |
| Number of patients with first Low Disease Activity State (LDAS) | Up to 5 Years | 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 |
| Number of patients with first Remission state | Up to 5 Years | 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 |
| 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 | Up to 5 Years | Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death |
| Response over the time will be assessed over 5 years on EULAR response, LDAS | Up to 5 years | — |
Outcome results
None listed