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

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

Study Overview

• Status: Withdrawn
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Orencia

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients included in SFR's ORA Registry

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RA patients treated by Orencia; RA patients treated by Orencia according to usual practice from June 1st 2007	Drug: Orencia; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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	Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death	Up to 5 Years
Response over the time will be assessed over 5 years on EULAR response, LDAS		Up to 5 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Anticipated): January 31, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: September 26, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: IM101-364