The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Non-interventional

• Registration Number: NCT03331393
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-16
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Primary Completion: 2019-01-17
• Study Completion: 2019-01-17
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients treated with Abatacept	Non-interventional	Treated with Abatacept as a first-line biologic
RA patients treated with TNFi	Non-interventional	Treated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Erythrocyte Sedimentation Rate	approximately 1 year	Erythrocyte sedimentation rate (ESR) levels
C-reactive Protein Levels	approximately 1 year	C-reactive protein (CRP) levels
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)
Joint Erosions	approximately 1 year	Measured by radiographic reports

Trial Locations

Locations (4)

Local Institution; 🇺🇸 Richland, Washington, United States

Medication Management, LLC; 🇺🇸 Greensboro, North Carolina, United States

Local Institution - 0005; 🇺🇸 Gainesville, Georgia, United States

Local Institution - 0007; 🇺🇸 Eagan, Minnesota, United States