Venous ThrombosesNCT03835780
The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a United Kingdom (UK) Matched Cohort Study
An observational study of Venous Thromboses and Venous Thromboembolism, run by Momentum Data at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboses, Venous Thromboembolism, Deep Vein Thrombosis
- How many people
- 266,890 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 1 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The exposed cohort includes 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 never diagnosed with a systemic inflammatory disease either prior to or during the study period by age and sex. Unexposed individuals require at least 1 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.
Who may be able to join
- Adult patients (aged ≥18) contributing to RCGP RCS primary care database between January 1, 1998 and January 1, 2018, will be eligible for inclusion
Who cannot join
- People with IBD which cannot be classified or is not ulcerative colitis or Crohn's disease will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Venous Thromboses, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Rheumatoid Arthritis, Inflammatory Bowel Diseases
- Being tested
- No intervention
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism, Pulmonary Embolism, Arthritis, Rheumatoid, Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
A observation of outcomes in usual practice
| Study group | Role | What they receive |
|---|---|---|
| People with inflammatory bowel disease | All individuals with an existing or incident diagnosis of IBD during the study period Receives: Other: No intervention | |
| People with rheumatoid arthritis | All individuals with an existing or incident diagnosis of RA during the study period Receives: Other: No intervention | |
| People with psoriatic arthritis | All individuals with an existing or incident diagnosis of IBD during the study period Receives: Other: No intervention | |
| Controls | Age, gender and primary care practice matched individuals without an existing or incident diagnosis of IBD, RA, or PsA during the study period Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Venous Thromboembolism (VTE)
Number of participants with systemic inflammatory disorders developing VTE (a composite of pulmonary embolism (PE) and deep vein thrombosis (DVT)) compared to population controls.
Measured: A 20 year analysis period (1999-2018 inclusive)
Secondary outcomes (2)
Risk of Pulmonary Embolism (PE)
Number of participants with systemic inflammatory disorders developing PE compared to population controls.
Measured: A 20 year analysis period (1999-2018 inclusive)
Risk of Deep Vein Thrombosis (DVT)
Number of participants with systemic inflammatory disorders developing DVT compared to population controls.
Measured: A 20 year analysis period (1999-2018 inclusive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Aug 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 266,890 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, University of Surrey
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Principal investigator, Momentum Data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835780
- Sponsor's protocol ID
- P004
- Status last verified
- May 2025
- First submitted
- 17 Jan 2019
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Irving PM, de Lusignan S, Tang D, Nijher M, Barrett K. Risk of common infections in people with inflammatory bowel disease in primary care: a population-based cohort study. BMJ Open Gastroenterol. 2021 Feb;8(1):e000573. doi: 10.1136/bmjgast-2020-000573.
PubMed 33597152Galloway J, Barrett K, Irving P, Khavandi K, Nijher M, Nicholson R, de Lusignan S, Buch MH. Risk of venous thromboembolism in immune-mediated inflammatory diseases: a UK matched cohort study. RMD Open. 2020 Sep;6(3):e001392. doi: 10.1136/rmdopen-2020-001392.
PubMed 32994362
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a UK Matched Cohort Study
- ClinicalTrials.gov ID
- NCT03835780
- Acronym / sponsor ID
- P004
- Conditions
- Venous Thromboses, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Rheumatoid Arthritis, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266,890 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer, University of Surrey
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| People with inflammatory bowel disease | – | Other: No interventionAll individuals with an existing or incident diagnosis of IBD during the study period |
| People with rheumatoid arthritis | – | Other: No interventionAll individuals with an existing or incident diagnosis of RA during the study period |
| People with psoriatic arthritis | – | Other: No interventionAll individuals with an existing or incident diagnosis of IBD during the study period |
| Controls | – | Other: No interventionAge, gender and primary care practice matched individuals without an existing or incident diagnosis of IBD, RA, or PsA during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The exposed cohort includes 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 never diagnosed with a systemic inflammatory disease either prior to or during the study period by age and sex. Unexposed individuals require at least 1 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.
Key inclusion criteria (1 listed)
- Adult patients (aged ≥18) contributing to RCGP RCS primary care database between January 1, 1998 and January 1, 2018, will be eligible for inclusion
Key exclusion criteria (1 listed)
- People with IBD which cannot be classified or is not ulcerative colitis or Crohn's disease will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionA observation of outcomes in usual practice | Other | Controls, People with inflammatory bowel disease, People with psoriatic arthritis, People with rheumatoid arthritis |
Primary outcome
Risk of Venous Thromboembolism (VTE)
Time frame: A 20 year analysis period (1999-2018 inclusive)
Number of participants with systemic inflammatory disorders developing VTE (a composite of pulmonary embolism (PE) and deep vein thrombosis (DVT)) compared to population controls.
2 secondary outcomes
Risk of Pulmonary Embolism (PE)
Time frame: A 20 year analysis period (1999-2018 inclusive)
Risk of Deep Vein Thrombosis (DVT)
Time frame: A 20 year analysis period (1999-2018 inclusive)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33597152Irving PM, de Lusignan S, Tang D, Nijher M, Barrett K. Risk of common infections in people with inflammatory bowel disease in primary care: a population-based cohort study. BMJ Open Gastroenterol. 2021 Feb;8(1):e000573. doi: 10.1136/bmjgast-2020-000573.
- Derived from this study: PubMed 32994362Galloway J, Barrett K, Irving P, Khavandi K, Nijher M, Nicholson R, de Lusignan S, Buch MH. Risk of venous thromboembolism in immune-mediated inflammatory diseases: a UK matched cohort study. RMD Open. 2020 Sep;6(3):e001392. doi: 10.1136/rmdopen-2020-001392.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew McGovern, MD principal investigator
Momentum Data
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboses and Venous Thromboembolism, run by Momentum Data at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of Venous Thromboembolism (VTE) (time frame: A 20 year analysis period (1999-2018 inclusive)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03835780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.