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Completed

NCT Number: NCT03331393

The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis

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

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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

Primary location

Local Institution, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Non-Interventional

Other

Non-interventional

Primary outcomes

  1. number of patients discontinuing treatment before completing 12 months of therapy

    Time frame: approximately 1 year

  2. time from treatment initiation to discontinuation

    Time frame: approximately 1 year

Secondary outcomes

  1. Distribution of Healthcare Resource Utilization (HCRU)

    Time frame: approximately 1 year

  2. Disease Activity Score

    Time frame: approximately 1 year

    Disease Activity Score (DAS)

  3. Health Assessment Questionnaire

    Time frame: approximately 1 year

    Health Assessment Questionnaire (HAQ)

  4. C-reactive Protein Levels

    Time frame: approximately 1 year

    C-reactive protein (CRP) levels

  5. Erythrocyte Sedimentation Rate

    Time frame: approximately 1 year

    Erythrocyte sedimentation rate (ESR) levels

  6. Joint Erosions

    Time frame: approximately 1 year

    Measured by radiographic reports

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Jul 6, 2022

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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