Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT01694693
Status:
WITHDRAWN
Last Update Posted:
2017-05-10
First Post:
2012-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Bristol-Myers Squibb
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business objectives have changed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: