Rheumatoid ArthritisNCT03908086
Bloodstream Infections in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Staphylococcus Aureus Bacteremia, run by Sabine Dieperink.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Staphylococcus Aureus Bacteremia
- What is being tested?
- Risk factors in RA cohort and Risk factors in general population
- How many people
- 6,000,000 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 1996to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- All members of the adult Danish population
Who cannot join
- Staphylococcus aureus bacteremia prior to inclusion.
- Rheumatoid arthritis diagnosed prior to inclusion.
About this study
Official title: Incidence and Risk Factors of Staphylococcus Aureus Bacteremia in Patients With Rheumatoid Arthritis Compared With the General Population
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
- Being tested
- Risk factors in RA cohort, Risk factors in general population
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk factors in RA cohortOther
Also called DMARDs (biologic and synthetic), Corticosteroids, RA disease activity, RA disease duration
Risk factors in general populationOther
Also called Prosthetic joints, Other comorbid conditions and surgical/dialysis procedures
| Study group | Role | What they receive |
|---|---|---|
| RA patients | Incident patients with rheumatoid arthritis as identified by the Danish National Patient Registry and the rheumatology registry, DANBIO. Receives: Other: Risk factors in RA cohort | |
| 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 Receives: Other: Risk factors in general population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of staphylococcus aureus bacteremia
Measured: 0-21 years
Incidence rate ratios
Comparing rheumatoid arthritis patients with the general population
Measured: 0-21 years
Secondary outcomes (1)
Risk factors of staphylococcus aureus bacteremia
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.)
Measured: 0-21 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start31 Dec 1996
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sabine Dieperink
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Aarhus, Statens Serum Institut
- Responsible party
- Sponsor-investigator, Sabine Dieperink, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908086
- Sponsor's protocol ID
- RA-SAB2018
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
Publications
Dieperink SS, Glintborg B, Oestergaard LB, Norgaard M, Benfield T, Mehnert F, Petersen A, Hetland ML. Risk factors for Staphylococcus aureus bacteremia in patients with rheumatoid arthritis and incidence compared with the general population: protocol for a Danish nationwide observational cohort study. BMJ Open. 2019 Sep 3;9(9):e030999. doi: 10.1136/bmjopen-2019-030999.
PubMed 31481566
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Staphylococcus Aureus Bacteremia in Patients With Rheumatoid Arthritis Compared With the General Population
- ClinicalTrials.gov ID
- NCT03908086
- Acronym / sponsor ID
- RA-SAB2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000,000 participants (estimated)
- Lead sponsor
- Sabine DieperinkUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Aarhus, Statens Serum Institut
- Study start
- 31 Dec 1996 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients | – | Other: Risk factors in RA cohortIncident patients with rheumatoid arthritis as identified by the Danish National Patient Registry and the rheumatology registry, DANBIO. |
| General population | – | Other: Risk factors in general populationAll other adults, as Identified by the Civil Registration System. Patients who develop RA contribute person-years in the general population cohort until RA diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All members of the adult Danish population
Key exclusion criteria (2 listed)
- Staphylococcus aureus bacteremia prior to inclusion.
- Rheumatoid arthritis diagnosed prior to inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk factors in RA cohortAlso: DMARDs (biologic and synthetic), Corticosteroids, RA disease activity, RA disease duration | Other | RA patients |
| Risk factors in general populationAlso: Prosthetic joints, Other comorbid conditions and surgical/dialysis procedures | Other | General population |
Primary outcome
Incidence of staphylococcus aureus bacteremia
Time frame: 0-21 years
Incidence rate ratios
Time frame: 0-21 years
Comparing rheumatoid arthritis patients with the general population
1 secondary outcome
Risk factors of staphylococcus aureus bacteremia
Time frame: 0-21 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 31481566Dieperink SS, Glintborg B, Oestergaard LB, Norgaard M, Benfield T, Mehnert F, Petersen A, Hetland ML. Risk factors for Staphylococcus aureus bacteremia in patients with rheumatoid arthritis and incidence compared with the general population: protocol for a Danish nationwide observational cohort study. BMJ Open. 2019 Sep 3;9(9):e030999. doi: 10.1136/bmjopen-2019-030999.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Staphylococcus Aureus Bacteremia, run by Sabine Dieperink.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of staphylococcus aureus bacteremia (time frame: 0-21 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.