Rheumatoid ArthritisNCT03496831
Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Simon Krabbe.
Trial summary
Background The risk for hospitalized infection (i.e. infection leading to hospitalization) in patients with inflammatory arthritis (rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with biological drugs is known to be increased compared to the background population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- What is being tested?
- Biologic Agents
- How many people
- 7,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 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: For each cohort, a set of matched controls from the general population will be obtained, so that outcomes in each diagnosis group can be compared with its own matched controls. Therefore, 3 groups of matched controls are constructed. Ten controls from the general population will be drawn for each patient matched by age, sex and postal code (replacement is allowed). Index date equal to date of start of first bDMARD. At the index date, controls must not have or have had one the diagnoses of RA, SpA or PsA listed above. Baseline variables (predictors) and outcomes (for definitions and details, see below) will be collected in the same time periods for each individual patient and his/her 10 matched controls.
Who may be able to join
- Patients with RA: Registered in DANBIO with a diagnosis of M05.9, M06.0 or M06.9.
- Patients with SpA: Registered in DANBIO with a diagnosis of M45.9, M46.1, M46.8+M02.9, M46.8+M07.4, M46.8+M07.5 or M46.9.
- Patients with PsA: Registered in DANBIO with a diagnosis of M07.3 or M46.8+M07.2.
- First bDMARD treatment course.
- Start of treatment with first bDMARD in the period January 1, 2006 to December 31, 2016.
- Age at start of treatment with first bDMARD ≥ 18 years.
Who cannot join
- Not followed in DANBIO since start of first bDMARD.
About this study
Official title: Development of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs
Background The risk for hospitalized infection (i.e. infection leading to hospitalization) in patients with inflammatory arthritis (rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with biological drugs is known to be increased compared to the background population. In daily clinical practice, there is a need for a simple way to assess the absolute risk for hospitalized infection in individual patients based on easily available information such as age, diagnosis, functional status, comorbidities and medication. This risk estimate will be useful in clinical decision making e.g. when advising patients on whether or not to initiate biologic therapy or when advising patients on influenza or pneumococcal vaccination.
Objectives The objectives are 1) to assess the risk for hospitalized infection (infection leading to hospitalization) in patients with inflammatory arthritis during 12 months of follow-up after initiating treatment with their first biological drug (bDMARD) with the risk in the general population, and 2) to develop a simple, clinically useful algorithm that allows prediction of the risk of hospitalized infection in individual patients.
Methods Observational cohort study based on existing data in: The Danish Rheumatology Register (DANBIO), The Danish National Patient Register, The Danish National Prescription Register and The Danish Register of Causes of Death. All patients registered in DANBIO with RA, PsA or axSpA who initiated treatment with their first biological drug between January 1, 2006 and December 31, 2016 will be identified. Baseline predictors and outcomes (hospitalized infection or death) during 12 months of follow-up are obtained. Logistic regression analysis and 10-fold cross-validation will be used to develop and internally validate the prediction model.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- Being tested
- Biologic Agents
- Keywords
- Hospitalization, Infection
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic AgentsDrug
Also called Abatacept, Adalimumab, Anakinra, Certolizumab
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Registered in DANBIO with a diagnosis of M05.9, M06.0 or M06.9. Receives: Drug: Biologic Agents | |
| Spondyloarthritis | Registered in DANBIO with a diagnosis of M45.9, M46.1, M46.8+M02.9, M46.8+M07.4, M46.8+M07.5 or M46.9. Receives: Drug: Biologic Agents | |
| Psoriatic Arthritis | Registered in DANBIO with a diagnosis of M07.3 or M46.8+M07.2. Receives: Drug: Biologic Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalized infection or death
Hospitalization caused by infection or death
Measured: 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Jan 2006
- 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.
- 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
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Krabbe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Simon Krabbe, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Merete L Hetland, DMSc, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496831
- Sponsor's protocol ID
- Predict-0001
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs
- ClinicalTrials.gov ID
- NCT03496831
- Acronym / sponsor ID
- Predict-0001
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- Keywords
- Hospitalization, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Simon KrabbeUniversity, hospital or other
- Collaborators
- University of Aarhus, Zealand University Hospital, University of Southern Denmark
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Apr 2018 (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.
Background The risk for hospitalized infection (i.e. infection leading to hospitalization) in patients with inflammatory arthritis (rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with biological drugs is known to be increased compared to the background population. In daily clinical practice, there is a need for a simple way to assess the absolute risk for hospitalized infection in individual patients based on easily available information such as age, diagnosis, functional status, comorbidities and medication. This risk estimate will be useful in clinical decision making e.g. when advising patients on whether or not to initiate biologic therapy or when advising patients on influenza or pneumococcal vaccination.
Objectives The objectives are 1) to assess the risk for hospitalized infection (infection leading to hospitalization) in patients with inflammatory arthritis during 12 months of follow-up after initiating treatment with their first biological drug (bDMARD) with the risk in the general population, and 2) to develop a simple, clinically useful algorithm that allows prediction of the risk of hospitalized infection in individual patients.
Methods Observational cohort study based on existing data in: The Danish Rheumatology Register (DANBIO), The Danish National Patient Register, The Danish National Prescription Register and The Danish Register of Causes of Death. All patients registered in DANBIO with RA, PsA or axSpA who initiated treatment with their first biological drug between January 1, 2006 and December 31, 2016 will be identified. Baseline predictors and outcomes (hospitalized infection or death) during 12 months of follow-up are obtained. Logistic regression analysis and 10-fold cross-validation will be used to develop and internally validate the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | Drug: Biologic AgentsRegistered in DANBIO with a diagnosis of M05.9, M06.0 or M06.9. |
| Spondyloarthritis | – | Drug: Biologic AgentsRegistered in DANBIO with a diagnosis of M45.9, M46.1, M46.8+M02.9, M46.8+M07.4, M46.8+M07.5 or M46.9. |
| Psoriatic Arthritis | – | Drug: Biologic AgentsRegistered in DANBIO with a diagnosis of M07.3 or M46.8+M07.2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- For each cohort, a set of matched controls from the general population will be obtained, so that outcomes in each diagnosis group can be compared with its own matched controls. Therefore, 3 groups of matched controls are constructed. Ten controls from the general population will be drawn for each patient matched by age, sex and postal code (replacement is allowed). Index date equal to date of start of first bDMARD. At the index date, controls must not have or have had one the diagnoses of RA, SpA or PsA listed above. Baseline variables (predictors) and outcomes (for definitions and details, see below) will be collected in the same time periods for each individual patient and his/her 10 matched controls.
Key inclusion criteria (6 listed)
- Patients with RA: Registered in DANBIO with a diagnosis of M05.9, M06.0 or M06.9.
- Patients with SpA: Registered in DANBIO with a diagnosis of M45.9, M46.1, M46.8+M02.9, M46.8+M07.4, M46.8+M07.5 or M46.9.
- Patients with PsA: Registered in DANBIO with a diagnosis of M07.3 or M46.8+M07.2.
- First bDMARD treatment course.
- Start of treatment with first bDMARD in the period January 1, 2006 to December 31, 2016.
Key exclusion criteria (1 listed)
- Not followed in DANBIO since start of first bDMARD.
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 |
|---|---|---|
| Biologic AgentsAlso: Abatacept, Adalimumab, Anakinra, Certolizumab | Drug | Psoriatic Arthritis, Rheumatoid Arthritis, Spondyloarthritis |
Primary outcome
Hospitalized infection or death
Time frame: 12 months of follow-up
Hospitalization caused by infection or death
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 17 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Merete L Hetland, DMSc study chair
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Simon Krabbe.
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 6 inclusion and 1 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 17 Apr 2018. 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?
Hospitalized infection or death (time frame: 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2018.