Clinical trial NCT01694693: 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
Official title: 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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in SFR's ORA Registry

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

Eligibility 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

Primary outcomes:
measure: Number of patients with first clinically significant Disease Activity Score (DAS) change
timeFrame: Up to 5 Years
measure: Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria]
timeFrame: Up to 5 Years
measure: Number of patients with first Low Disease Activity State (LDAS)
timeFrame: Up to 5 Years
measure: Number of patients with first Remission state
timeFrame: Up to 5 Years
measure: Number of patients disease progression with prior improvement
timeFrame: Up to 5 Years
measure: Number of patients disease progression with no prior improvement
timeFrame: Up to 5 Years
measure: Number of patients with modification of Orencia administration condition
timeFrame: Up to 5 Years
measure: Number of patients discontinued and switched from Orencia
timeFrame: Up to 5 Years
measure: Incidence rate of any type of Adverse events related to Orencia
timeFrame: Up to 5 Years
measure: Number of patients with specific predefined events
timeFrame: Up to 5 Years
measure: Response over the time will be assessed over 5 years on EULAR response, LDAS
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: