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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01694693
• Other study ID #: IM101-364
• Status: Withdrawn
• Phase: N/A
• First received: September 24, 2012
• Last updated: May 9, 2017
• Start date: January 31, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Orencia
No Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of patients disease progression with prior improvement		Up to 5 Years
Primary	Number of patients disease progression with no prior improvement		Up to 5 Years
Primary	Number of patients with modification of Orencia administration condition		Up to 5 Years
Primary	Number of patients discontinued and switched from Orencia		Up to 5 Years
Primary	Incidence rate of any type of Adverse events related to Orencia		Up to 5 Years
Primary	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
Primary	Response over the time will be assessed over 5 years on EULAR response, LDAS		Up to 5 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls