Rheumatoid Arthritis Clinical Trial
Official title:
The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a UK Matched Cohort Study
Blood clots occurring in the legs and in the lungs are relatively common; they occur in
around 3 in a 1000 people per year. They can cause disability and are also potentially life
threatening. When a clot occurs in the legs it is called a deep vein thrombosis or DVT. When
they occur in the lungs they are called a pulmonary embolism or PE. The risk for DVT and PE
is higher in people with conditions which cause inflammation. The most common of these are
inflammatory bowel disease (ulcerative colitis and Crohn's disease), rheumatoid arthritis,
and psoriatic arthritis (a condition comprised of psoriasis and joint inflammation).
What is not known is how much higher the risk of DVT and PE is in these groups compared with
people without inflammatory disease, and what causes the excess risk in these people. This
study aims to assess the measure the exact increase in risk for DVT and PE in people with
these inflammatory conditions and to identify which risk factors are most strongly associated
with the increased risk. These data should help with an understand the causes of blood clot
risk in these inflammatory conditions and in identify targets for reducing risk.
Background
Venous thromboembolism (VTE), comprising pulmonary embolism (PE) and deep vein thrombosis
(DVT), are common and associated with significant morbidity and mortality. VTE risk is higher
in chronic inflammatory conditions including inflammatory bowel disease (IBD) and rheumatoid
arthritis (RA) compared to the general population. Evidence for differential VTE risk in
other inflammatory diseases, notably psoriatic arthritis (PsA) and vasculitis, is more
limited. Risk factors for VTE have been described in the general population, but there has
been little interrogation of VTE risk factors for individuals with chronic inflammatory
conditions and their association with subsequent VTE.
Objective
This study aims to describe the prevalence of VTE risk and risk factors in individuals with
systemic inflammatory disorders in a contemporary real-world population, by disease type
(IBD, RA, and PsA) and relative to a control population without systemic inflammatory
disease. In the same cohorts a further comparison will be performed of the influence of VTE
risk factors on risk of VTE events in individuals with systemic inflammatory disorders.
Method
A retrospective cohort study will be performed to compare VTE risk and VTE risk factors in
adults with IBD, RA, and PsA and matched controls between January 1, 1998 and January 1,
2018, within the Royal College of General Practitioners (RCGP) Research and Surveillance
Centre (RSC) network. In the cohorts with and without inflammatory conditions estimate will
be determined for the risk of VTE overall, and for PE and DVT separately, using unadjusted
Cox proportional hazards models, stratified by matched set (exposed cohort versus unexposed
cohort), to provide overall hazard ratios for the association with each outcome. Models will
be subsequently adjusted for sociodemographic and clinical and VTE risk factors in
multivariable analysis to explore potentially important associations with VTE. The same
analyses for each autoimmune condition will be repeated separately. Prespecified sensitivity
analyses will be performed to explore the robustness of any potential associations.
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