The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a United Kingdom (UK) Matched Cohort Study

Sponsor

Momentum Data (Industry)

Overall Status

Completed

CT.gov ID

NCT03835780

Collaborator

Pfizer (Industry), University of Surrey (Other)

266,890

Enrollment

Location

Actual Duration (Months)

26810.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboses Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolism Rheumatoid Arthritis Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease Psoriatic Arthritis	Other: No intervention

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

266890 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a UK Matched Cohort Study

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
People with inflammatory bowel disease All individuals with an existing or incident diagnosis of IBD during the study period	Other: No intervention A observation of outcomes in usual practice
People with rheumatoid arthritis All individuals with an existing or incident diagnosis of RA during the study period	Other: No intervention A observation of outcomes in usual practice
People with psoriatic arthritis All individuals with an existing or incident diagnosis of IBD during the study period	Other: No intervention A observation of outcomes in usual practice
Controls Age, gender and primary care practice matched individuals without an existing or incident diagnosis of IBD, RA, or PsA during the study period	Other: No intervention A observation of outcomes in usual practice

Outcome Measures

Primary Outcome Measures

Time to venous thromboembolism (VTE) [A 20 year analysis period (1999-2018 inclusive)]
Time to VTE (a composite of PE and DVT) in individuals with systemic inflammatory disorders compared to population controls.

Secondary Outcome Measures

Time to pulmonary embolism (PE) [A 20 year analysis period (1999-2018 inclusive)]
Time to PE in individuals with systemic inflammatory disorders compared to population controls.
Time to deep vein thrombosis (DVT) [A 20 year analysis period (1999-2018 inclusive)]
Time to DVT in individuals with systemic inflammatory disorders compared to population controls.