The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis
1 other identifier
observational
265
1 country
7
Brief Summary
The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2017
CompletedFirst Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2019
CompletedJuly 6, 2022
July 1, 2022
1.8 years
October 17, 2017
July 1, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
number of patients discontinuing treatment before completing 12 months of therapy
approximately 1 year
time from treatment initiation to discontinuation
approximately 1 year
Secondary Outcomes (6)
Distribution of Healthcare Resource Utilization (HCRU)
approximately 1 year
Disease Activity Score
approximately 1 year
Health Assessment Questionnaire
approximately 1 year
C-reactive Protein Levels
approximately 1 year
Erythrocyte Sedimentation Rate
approximately 1 year
- +1 more secondary outcomes
Study Arms (2)
RA patients treated with Abatacept
Treated with Abatacept as a first-line biologic
RA patients treated with TNFi
Treated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic
Interventions
Non-interventional
Eligibility Criteria
Rapidly-progressing RA patients initiating treatment with abatacept or TNFi at approximately 10 rheumatology practices across the US.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Local Institution
Beverly Hills, California, 90212, United States
Local Institution - 0005
Gainesville, Georgia, 30501, United States
Local Institution
Coeur d'Alene, Idaho, 83814-2644, United States
Local Institution - 0007
Eagan, Minnesota, 55121, United States
Medication Management, LLC
Greensboro, North Carolina, 27408, United States
Local Institution
Myrtle Beach, South Carolina, 29572, United States
Local Institution
Richland, Washington, 99352, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
November 6, 2017
Study Start
March 16, 2017
Primary Completion
January 17, 2019
Study Completion
January 17, 2019
Last Updated
July 6, 2022
Record last verified: 2022-07