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Trial record 55 of 2725 for:    Rheumatoid Arthritis

Bloodstream Infections in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03908086
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborators:
University of Copenhagen
University of Aarhus
Statens Serum Institut
Information provided by (Responsible Party):
Sabine Dieperink, Rigshospitalet, Denmark

Brief Summary:
Study of incidence and risk factors of staphylococcus aureus bacteremia in patients with rheumatoid arthritis compared with the general population in a nationwide cohort of all adult members of the population from 1996 until 2017 using national registries

Condition or disease Intervention/treatment
Rheumatoid Arthritis Staphylococcus Aureus Bacteremia Other: Risk factors in RA cohort Other: Risk factors in general population

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Study Type : Observational
Estimated Enrollment : 6000000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence and Risk Factors of Staphylococcus Aureus Bacteremia in Patients With Rheumatoid Arthritis Compared With the General Population
Actual Study Start Date : December 31, 1996
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RA patients
Incident patients with rheumatoid arthritis as identified by the Danish National Patient Registry and the rheumatology registry, DANBIO.
Other: Risk factors in RA cohort
Other Names:
  • DMARDs (biologic and synthetic)
  • Corticosteroids
  • RA disease activity
  • RA disease duration
  • Tobacco use
  • Joint erosions
  • Prosthetic joints
  • Other comorbid conditions and surgical/dialysis procedures

General population
All other adults, as Identified by the Civil Registration System. Patients who develop RA contribute person-years in the general population cohort until RA diagnosis
Other: Risk factors in general population
Other Names:
  • Prosthetic joints
  • Other comorbid conditions and surgical/dialysis procedures




Primary Outcome Measures :
  1. Incidence of staphylococcus aureus bacteremia [ Time Frame: 0-21 years ]
  2. Incidence rate ratios [ Time Frame: 0-21 years ]
    Comparing rheumatoid arthritis patients with the general population


Secondary Outcome Measures :
  1. Risk factors of staphylococcus aureus bacteremia [ Time Frame: 0-21 years ]
    Identification of risk factors both universal to both the general population and rheumatoid arthritis (RA) cohorts and RA disease specific factors (disease duration, disease activity, smoking, joint erosions, etc.)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
All individuals alive and living in Denmark on December 31, 1996 as identified by the Civil Registration System are included. Individuals are dynamically included during the study period if they immigrate or turn 18. Individuals are followed up until first-time SAB, death, emigration or December 31, 2017, whichever comes first.
Criteria

Inclusion Criteria:

  • All members of the adult Danish population

Exclusion Criteria:

  • Staphylococcus aureus bacteremia prior to inclusion.
  • Rheumatoid arthritis diagnosed prior to inclusion.

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Responsible Party: Sabine Dieperink, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03908086     History of Changes
Other Study ID Numbers: RA-SAB2018
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Bacteremia
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes