The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| RA patients treated with Abatacept Treated with Abatacept as a first-line biologic |
Other: Non-interventional
Non-interventional
|
| RA patients treated with TNFi Treated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic |
Other: Non-interventional
Non-interventional
|
Outcome Measures
Primary Outcome Measures
- number of patients discontinuing treatment before completing 12 months of therapy [approximately 1 year]
- time from treatment initiation to discontinuation [approximately 1 year]
Secondary Outcome Measures
- Distribution of Healthcare Resource Utilization (HCRU) [approximately 1 year]
- Disease Activity Score [approximately 1 year]
Disease Activity Score (DAS)
- Health Assessment Questionnaire [approximately 1 year]
Health Assessment Questionnaire (HAQ)
- C-reactive Protein Levels [approximately 1 year]
C-reactive protein (CRP) levels
- Erythrocyte Sedimentation Rate [approximately 1 year]
Erythrocyte sedimentation rate (ESR) levels
- Joint Erosions [approximately 1 year]
Measured by radiographic reports
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age at enrollment
-
Confirmed diagnosed with RA
-
Initiated first-line treatment with abatacept, adalimumab, etanercept, or infliximab with a record of the start date at the practice site
Exclusion Criteria:
-
Does not have at least 1 or more poor RA prognostic factor: Evidence of joint erosions, Positive anti-CCP autoantibodies, Positive RF autoantibodies, Increased CRP levels, Increased ESR levels
-
Was followed at the site for less than 1 year since biologic treatment initiation
-
Patients with autoimmune diseases: Crohn's, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, anal fistula
Other protocol defined inclusion/exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Beverly Hills | California | United States | 90212 |
| 2 | Local Institution - 0005 | Gainesville | Georgia | United States | 30501 |
| 3 | Local Institution | Coeur d'Alene | Idaho | United States | 83814-2644 |
| 4 | Local Institution - 0007 | Eagan | Minnesota | United States | 55121 |
| 5 | Medication Management, LLC | Greensboro | North Carolina | United States | 27408 |
| 6 | Local Institution | Myrtle Beach | South Carolina | United States | 29572 |
| 7 | Local Institution | Richland | Washington | United States | 99352 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IM101-686