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Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03496831
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
University of Aarhus
Zealand University Hospital
University of Southern Denmark
Information provided by (Responsible Party):
Simon Krabbe, Rigshospitalet, Denmark

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Spondyloarthritis Psoriatic Arthritis Drug: Biologic Agents

Study Design
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Study Type : Observational
Estimated Enrollment : 7500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs
Actual Study Start Date : January 1, 2006
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Rheumatoid Arthritis
Registered in DANBIO with a diagnosis of M05.9, M06.0 or M06.9.
 Drug: Biologic Agents
Other Names:
  • Abatacept
  • Adalimumab
  • Anakinra
  • Certolizumab
  • Etanercept
  • Golimumab
  • Infliximab
  • Rituximab
  • Secukinumab
  • Tocilizumab
  • Ustekinumab
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.
 Drug: Biologic Agents
Other Names:
  • Abatacept
  • Adalimumab
  • Anakinra
  • Certolizumab
  • Etanercept
  • Golimumab
  • Infliximab
  • Rituximab
  • Secukinumab
  • Tocilizumab
  • Ustekinumab
Psoriatic Arthritis
Registered in DANBIO with a diagnosis of M07.3 or M46.8+M07.2.
 Drug: Biologic Agents
Other Names:
  • Abatacept
  • Adalimumab
  • Anakinra
  • Certolizumab
  • Etanercept
  • Golimumab
  • Infliximab
  • Rituximab
  • Secukinumab
  • Tocilizumab
  • Ustekinumab


Outcome Measures
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Primary Outcome Measures :
  1. Hospitalized infection or death [ Time Frame: 12 months of follow-up ]
    Hospitalization caused by infection or death


Eligibility Criteria
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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
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.
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

- Not followed in DANBIO since start of first bDMARD.

Contacts and Locations
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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): NCT03496831


Sponsors and Collaborators
Simon Krabbe
University of Aarhus
Zealand University Hospital
University of Southern Denmark
Investigators
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Study Chair: Merete L Hetland, DMSc Rigshospitalet, Denmark
  Study Documents (Full-Text)

Documents provided by Simon Krabbe, Rigshospitalet, Denmark:
Study Protocol and Statistical Analysis Plan  [PDF] April 5, 2018

More Information
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Responsible Party: Simon Krabbe, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03496831    
Other Study ID Numbers: Predict-0001
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Krabbe, Rigshospitalet, Denmark:
Hospitalization
Infection
Additional relevant MeSH terms:
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Infections
Arthritis
Arthritis, Psoriatic
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Etanercept
 Golimumab
Abatacept
Infliximab
Ustekinumab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents