Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03496831
Study type Observational
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase
Start date January 1, 2006
Completion date December 31, 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT01076205 - Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis N/A
Enrolling by invitation NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Enrolling by invitation NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Active, not recruiting NCT02648035 - EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT01087125 - Abatacept Pregnancy Exposure Registry
Recruiting NCT03312465 - Anatomical Shoulder Domelock System Study N/A
Recruiting NCT01942174 - VACcination In Methotrexate Treated Rheumatoid Arthritis Patients Phase 3
Completed NCT02139345 - TC-A Registration Study N/A
Completed NCT00069342 - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed NCT02885181 - Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate Phase 2
Not yet recruiting NCT03254966 - Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients Phase 2
Not yet recruiting NCT03061877 - Anxiety Depression and Rheumatoid Arthritis N/A
Recruiting NCT02897011 - 2-week dc of MTX and Influenza Vaccination in RA N/A
Recruiting NCT02930343 - Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy Phase 4
Recruiting NCT02666443 - Low Dose Dexamethasone in Supraclavicular Blocks N/A
Recruiting NCT02820038 - Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management N/A
Recruiting NCT02764515 - Kunxian for the Treatment of Rheumatoid Arthritis Phase 4
Recruiting NCT02535832 - Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA) Phase 1