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

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: NCT03835780
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
Pfizer
University of Surrey
Information provided by (Responsible Party):
Momentum Data

Study Description
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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
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
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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 : February 1, 2019
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Time to venous thromboembolism (VTE) [ Time Frame: 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 :
  1. Time to pulmonary embolism (PE) [ Time Frame: A 20 year analysis period (1999-2018 inclusive) ]
    Time to PE in individuals with systemic inflammatory disorders compared to population controls.

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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The exposed cohort will include all individuals with an existing or incident diagnosis of IBD, RA or PsA (systemic inflammatory diseases) in the RCGP RSC over the study period. IBD, RA or PsA will be identified using Read diagnostic codes previously validated in UK primary care studies.

The matched unexposed cohort will be defined by matching individuals in the exposed cohort with individuals who have never been diagnosed with a systemic inflammatory disease either prior to or during the study period by age and sex at GP practice level. Unexposed individuals will require at least one year of follow-up when matched to minimize the risk they had a non-recorded existing diagnosis of a systemic inflammatory disease of interest. Follow-up for each matched individual will begin at the start of follow-up of their matched counterpart.

Criteria

Inclusion Criteria:

  • Adult patients (aged ≥18) contributing to RCGP RCS primary care database between January 1, 1998 and January 1, 2018, will be eligible for inclusion

Exclusion Criteria:

  • People with IBD which cannot be classified or is not ulcerative colitis or Crohn's disease will be excluded.
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): NCT03835780


Locations
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United Kingdom
Momentum Data Ltd
London, United Kingdom, WC1X 8QT
Sponsors and Collaborators
Momentum Data
Pfizer
University of Surrey
  Study Documents (Full-Text)

Documents provided by Momentum Data:
Study Protocol and Statistical Analysis Plan  [PDF] December 6, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Momentum Data
ClinicalTrials.gov Identifier: NCT03835780    
Other Study ID Numbers: P004
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Crohn Disease
Inflammatory Bowel Diseases
Pulmonary Embolism
Thrombosis
Embolism
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Joint Diseases
Musculoskeletal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Intestinal Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases