Factors Associated With Biologic DMARD Switching

NCT02346942 | Completed

• 1 other identifier: IM101-474
• Study Type: observational
• Target: 4,099
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Primary objective of this study is to understand the rheumatoid arthritis (RA) population in national integrated delivery network who are treated with first- or second-line biologic disease modifying anti-rheumatic drug (bDMARD) therapy (with or without Methotrexate) and to evaluate switching patterns and reasons for switching to another bDMARD.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Measure the change in population of patients who are treated with first- or second-line bDMARD therapy (with or without Methotrexate) to another bDMARD therapy

  biologic disease modifying anti-rheumatic drug (bDMARD)

  Approximately 12 months

• Measure the change in population of patients who are treated with first- or second-line bDMARD therapy (with or without Methotrexate) to another bDMARD therapy

  Approximately 6 months

• Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes

  12 month post index follow up

• Measure the reasons for switching to another bDMARD based on Provider documentation in chart notes

  6 months pre-index date

Secondary Outcomes (1)

• Evaluate RA related and all cause healthcare resource utilization of doctor visits, hospitalizations and ER visits as patients switch bDMARDs measured from Patient heath claims data from KPSC integrated healthcare data

  6 month pre-index and 6 months pre-index date and 12 month post index follow up

Study Arms (2)

Patients who have no history of bDMARD therapy use

Patients who have a prior history of bDMARD therapy use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individual patients with RA will be identified using electronic medical records from 01/01/2007 to 10/31/2012. The medical file contains data on diagnostic and therapeutic services rendered in both inpatient and outpatient settings. The diagnoses and procedures for these services are coded using ICD-9-CM, Current Procedural Terminology (CPT), and Diagnosis-Related Group (DRG) codes with service dates.

You may qualify if:

• Diagnosis of RA (ICD-9 714.xx) anytime during the study time period of 1/1/2007 to 10/31/2012
• Patients ≥18 years of age at diagnosis date
• Required to have to have 6 months pre-index and 12 months post-index continuous membership and drug benefit eligibility in the database

You may not qualify if:

• Patients less than 18 years of age on diagnosis date
• If they had a diagnosis of Crohn's disease, psoriasis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, regional enteritis, or anal fistula during the pre-index period
• Patients who had \<7 days supply of adalimumab or etanercept
• Patients currently in a clinical trial during our study
• If patients are in the second-line cohort and have more than 1 prior bDMARD

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: January 27, 2015
• Study Start: June 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02