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OpenTrials
Completed

NCT Number: NCT02346942

Factors Associated With Biologic DMARD Switching

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: Approximately 12 months

    biologic disease modifying anti-rheumatic drug (bDMARD)

  2. 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

    Time frame: Approximately 6 months

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

    Time frame: 12 month post index follow up

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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Factors Associated With Biologic Disease Modifying Antirheumatic Drugs Switching and Impact of Healthcare Resource Utilization in a Managed Care Setting

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2015
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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