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

Rheumatoid Arthritis Clinical Trial

Official title:

Development of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03496831
• Other study ID #: Predict-0001
• Status: Completed
• First received: April 5, 2018
• Last updated: April 12, 2018
• Start date: January 1, 2006
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7500
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Infection
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis

Intervention

Drug:
• Biologic Agents

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Simon Krabbe	University of Aarhus, University of Southern Denmark, Zealand University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalized infection or death	Hospitalization caused by infection or death	12 months of follow-up