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

Withdrawn

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Orencia

• Registration Number: NCT01694693
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10
• Study Start: 2018-01-31
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Patients treated by Orencia in the context of clinical trials

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients treated by Orencia	Orencia	RA patients treated by Orencia according to usual practice from June 1st 2007

Primary Outcome Measures

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