The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis

The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis: A Chart Review Study

The purpose of this study is to investigate the value of Orencia in rapidly progressing Rheumatoid Arthritis (RA).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Non-interventional

• Study Type: Observational
• Enrollment (Actual): 265

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Local Institution
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Local Institution - 0005
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814-2644
      • Local Institution
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Local Institution - 0007
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Medication Management, LLC
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Local Institution
  • Washington
    • Richland, Washington, United States, 99352
      • Local Institution

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

Rapidly-progressing RA patients initiating treatment with abatacept or TNFi at approximately 10 rheumatology practices across the US.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Distribution of Healthcare Resource Utilization (HCRU)		approximately 1 year
Disease Activity Score	Disease Activity Score (DAS)	approximately 1 year
Health Assessment Questionnaire	Health Assessment Questionnaire (HAQ)	approximately 1 year
C-reactive Protein Levels	C-reactive protein (CRP) levels	approximately 1 year
Erythrocyte Sedimentation Rate	Erythrocyte sedimentation rate (ESR) levels	approximately 1 year
Joint Erosions	Measured by radiographic reports	approximately 1 year

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Actual): January 17, 2019
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

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
• Other Study ID Numbers: IM101-686