The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331393
• Other study ID #: IM101-686
• Status: Completed
• Start date: March 16, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: July 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Non-interventional
Non-interventional

Locations

Country	Name	City	State
United States	Local Institution	Beverly Hills	California
United States	Local Institution	Coeur d'Alene	Idaho
United States	Local Institution - 0007	Eagan	Minnesota
United States	Local Institution - 0005	Gainesville	Georgia
United States	Medication Management, LLC	Greensboro	North Carolina
United States	Local Institution	Myrtle Beach	South Carolina
United States	Local Institution	Richland	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients discontinuing treatment before completing 12 months of therapy		approximately 1 year
Primary	time from treatment initiation to discontinuation		approximately 1 year
Secondary	Distribution of Healthcare Resource Utilization (HCRU)		approximately 1 year
Secondary	Disease Activity Score	Disease Activity Score (DAS)	approximately 1 year
Secondary	Health Assessment Questionnaire	Health Assessment Questionnaire (HAQ)	approximately 1 year
Secondary	C-reactive Protein Levels	C-reactive protein (CRP) levels	approximately 1 year
Secondary	Erythrocyte Sedimentation Rate	Erythrocyte sedimentation rate (ESR) levels	approximately 1 year
Secondary	Joint Erosions	Measured by radiographic reports	approximately 1 year

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls