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Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Participants With Rheumatoid Arthritis (RA) Who Are Treated With Abatacept or Tumor Necrosis Factor Inhibitors in Australia

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ClinicalTrials.gov Identifier: NCT03663829
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
An observational study assessing the impact of anti-citrullinated antibody (ACPA) in rheumatoid arthritis (RA) participants who have received abatacept or tumour necrosis factor inhibitors (TNFi) from the Optimising Patient outcome in Australian rheumatoLogy (OPAL) registry

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

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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Patients With Rheumatoid Arthritis Who Are Treated With Abatacept or Tumour Necrosis Factor Inhibitors. An Analysis From the Optimising Patient Outcome in Australian Rheumatology (OPAL) Registry.
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Participants RA who have received a TNFi Other: Non-Interventional
Non-Interventional

Participants with RA who have received abatacept Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. ACPA (Anti-cyclic citrullinated peptide) status [ Time Frame: Pre-Index ]
    ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US


Secondary Outcome Measures :
  1. Number of participants with positive ACPA [ Time Frame: Index ]
    ACPA-positive greater than or equal to 5 Ru/mL in Australia, greater than or equal to 20 Ru/mL in US

  2. Number of participants with negative ACPA [ Time Frame: Index ]
    ACPA-negative less than or equal to 5 Ru/mL in Australia, less than or equal to 20 Ru/mL in US

  3. CDAI (clinical disease activity index) score [ Time Frame: Index plus or minus 1 month ]
    Remission CDAI <2.9 Low disease activity CDAI ≥ 2.9 but <10.0 Moderate disease activity CDAI ≥ 10.1 but <22.0 High disease activity CDAI ≥ 22.0

  4. CDAI (clinical disease activity index) score [ Time Frame: 12 months plus or minus 3 months ]
    Remission CDAI <2.9 Low disease activity CDAI ≥ 2.9 but <10.0 Moderate disease activity CDAI ≥ 10.1 but <22.0 High disease activity CDAI ≥ 22.0

  5. DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score [ Time Frame: Index plus or minus 1 month ]
    The DAS-28 CRP-3 is a measure of disease activity in rheumatoid arthritis (RA) that assesses 28 joints in RA commonly affected. The DAS-28 CRP 3 takes into account tender and swollen joint counts and CRP level (measure of inflammation in the blood). The DAS-28 CRP 3 measure does not include patient global assessment of health.

  6. DAS28 (disease activity score 28)-CRP-3 (C reactive protein) score [ Time Frame: 12 months plus or minus 3 months ]
    The DAS-28 CRP-3 is a measure of disease activity in rheumatoid arthritis (RA) that assesses 28 joints in RA commonly affected. The DAS-28 CRP 3 takes into account tender and swollen joint counts and CRP level (measure of inflammation in the blood). The DAS-28 CRP 3 measure does not include patient global assessment of health.

  7. Number of participants with treatment persistence [ Time Frame: Approximately 11 years and 5 months ]
  8. Number of participants with treatment discontinuation [ Time Frame: Approximately 11 years and 5 months ]
  9. Number of participants identified as taking abatacept [ Time Frame: Index ]
  10. Number of participants identified as taking TNFi (tumor necrosis factor inhibitor) [ Time Frame: Index ]
  11. Number of participants that achieved remission [ Time Frame: 12 months plus or minus 3 months ]
    Remission CDAI <2.9 Low disease activity CDAI ≥ 2.9 but <10.0 Moderate disease activity CDAI ≥ 10.1 but <22.0 High disease activity CDAI ≥ 22.0



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of rheumatoid arthritis (RA) who have received a TNFi or abatacept and registered in the OPAL registry
Criteria

Inclusion Criteria:

  • Diagnosed with rheumatoid arthritis
  • Have a baseline ACPA recorded
  • Received either abatacept or a TNFi (adalimumab, certolizumab, etanercept or golimumab) during the sample selection window 1 August 2006 to 30 June 2017

Exclusion Criteria:

  • Patients who have died
  • Patients with concomitant inflammatory diseases (e.g. ankylosing spondylitis, psoriatic arthritis, Crohn's disease, ulcerative colitis)
  • Patients who have no visit data recorded (even if medication data is available)

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): NCT03663829


Locations
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Australia
Canberra City, Australia
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: NCT03663829    
Other Study ID Numbers: IM101-728
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes