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The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03331393
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Non-interventional

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Value of Orencia in Rapidly Progressing Rheumatoid Arthritis: A Chart Review Study
Actual Study Start Date : March 16, 2017
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
RA patients treated with Abatacept
Treated with Abatacept as a first-line biologic
Other: Non-interventional
Non-interventional

RA patients treated with TNFi
Treated with Tumor necrosis factor inhibitor (TNFi) as a first-line biologic
Other: Non-interventional
Non-interventional




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rapidly-progressing RA patients initiating treatment with abatacept or TNFi at approximately 10 rheumatology practices across the US.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331393


Locations
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United States, California
Local Institution
Beverly Hills, California, United States, 90212
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03331393     History of Changes
Other Study ID Numbers: IM101-686
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents