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CompletedNCT04969653Updated Dec 9, 2024Results posted

The Incidence of Venous Thromboembolism in Atopic Dermatitis

An observational study in Venous Thromboembolism, Atopic Dermatitis and Pulmonary Embolism, sponsored by Momentum Data. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Momentum Data · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
754,745
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.

Read the detailed description

The aim of this study is to examine whether venous thromboembolism is higher in people with atopic dermatitis compared and those without and to explore the risk in particular subgroups of people with AD such as those with higher body mass index or using oestrogen containing contraceptives. Such insights will be valuable for clinicians in advising patients with atopic dermatitis regarding venous thromboembolism prevention and detection and when selecting atopic dermatitis treatments.

02

Conditions studied

  • Venous Thromboembolism
  • Atopic Dermatitis
  • Pulmonary Embolism
  • Deep Vein Thrombosis
  • Allergic Rhinitis
  • Allergy to House Dust Mite
  • Allergy to Animal Dander
  • Food Allergy
  • Cows Milk Allergy
03

In context

Venous Thromboembolism

712 studies on the registry are indexed under Venous Thromboembolism; 146 are open to participants now.

This study's enrollment of 754,745 is above the median of 700 across 282 observational studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

Momentum Data is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All eligible adult people (aged ≥ 18) registered with GP practices contributing data to OPCRD between January 1, 2010 and January 1, 2020, were eligible for inclusion in the study.

Exclusion criteria

Exclusion Criteria:

  • People with less than 5 years potential follow up. People with atopic dermatitis that was not active atopic dermatitis during the study period. People without atopic dermatitis but diagnosed with other skin conditions.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
754,745 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases

    All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.

    Other: Exposure of venous thromboembolism

  • Controls

    Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.

    Other: Exposure of venous thromboembolism

Interventions

  • OtherExposure of venous thromboembolism

    Composite of pulmonary embolism and deep vein thrombosis

06

What researchers measure

Primary outcomes

  1. Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.

    To describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

Secondary outcomes

  1. Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person

    To describe the risk of pulmonary embolism in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

  2. Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person

    To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

  3. Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore the risk of VTE stratified by the male sex at the baseline in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

  4. Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore the risk of VTE stratified by the female sex at the baseline in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

  5. Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore the risk of VTE stratified by those aged 18-44 at the baseline in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

  6. Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore the risk of VTE stratified by those aged 45-64 at the baseline in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

  7. Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore the risk of VTE stratified by those aged ≥65 at the baseline in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

  8. Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore the risk of VTE stratified by those with a BMI \<30 at the baseline with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.

    Time frame: 10 years from index date

  9. Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore the risk of VTE stratified by those with a BMI ≥30 at the baseline in people with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.

    Time frame: 10 years from index date

  10. Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore the risk of VTE stratified by oestrogen contraceptive use in females aged 18-44 years at the baseline in people with active AD compared to a matched control population.

    Time frame: 10 years from index date

  11. Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

    To explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline in people with active AD compared to a matched control population.. Allergic conditions will comprise common allergies; allergic rhinitis, allergy to dust mites or animal dander, and food allergies e.g., nut, fruit, shellfish, eggs and cows' milk allergies. Medication and other allergies will not be included.

    Time frame: 10 years from index date

07

Results

Posted Dec 9, 2024

Participant flow

Participant flow — Overall Study
MilestoneCasesControls
Started150975603770
Completed150975603770
Not completed00

Outcome measures

PrimaryNumber of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.

To describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.
ParticipantsCasesControls
Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.25767563
SecondaryNumber of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person

To describe the risk of pulmonary embolism in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person7972942
SecondaryNumber of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person

To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person18874934
SecondaryNumber of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore the risk of VTE stratified by the male sex at the baseline in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person10703170
SecondaryNumber of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore the risk of VTE stratified by the female sex at the baseline in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person15064393
SecondaryNumber of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore the risk of VTE stratified by those aged 18-44 at the baseline in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person5031592
SecondaryNumber of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore the risk of VTE stratified by those aged 45-64 at the baseline in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person6391858
SecondaryNumber of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore the risk of VTE stratified by those aged ≥65 at the baseline in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person14344113
SecondaryNumber of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore the risk of VTE stratified by those with a BMI \<30 at the baseline with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person13983188
SecondaryNumber of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore the risk of VTE stratified by those with a BMI ≥30 at the baseline in people with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person685760
SecondaryNumber of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore the risk of VTE stratified by oestrogen contraceptive use in females aged 18-44 years at the baseline in people with active AD compared to a matched control population.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person3134
SecondaryNumber of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

To explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline in people with active AD compared to a matched control population.. Allergic conditions will comprise common allergies; allergic rhinitis, allergy to dust mites or animal dander, and food allergies e.g., nut, fruit, shellfish, eggs and cows' milk allergies. Medication and other allergies will not be included.

Time frame:
10 years from index date
Reported as:
Count of participants · Participants
Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
ParticipantsCasesControls
Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person193203

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cases———
Controls———

Baseline characteristics

Age, Continuous
Age, Continuous(years)CasesControlsTotal
Median40.0 (23.0 to 62.0)41.0 (23.0 to 62.0)41.0 (23.0 to 62.0)
Age, Customized
Age, Customized(Participants)CasesControlsTotal
18-2954634213727268361
30-392059980118100717
40-49179038021198114
50-59157656134377108
60-69173757157188946
70-79150815845273533
80+96183834847966
Sex: Female, Male
Sex: Female, Male(Participants)CasesControlsTotal
Female89093356311445404
Male61882247459309341
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CasesControlsTotal
White87748331717419465
Asian or Asian British126353838851023
Black or Black British202179039924
Mixed139642815677
Not stated46382134925987
Other75032690734410
Missing35034173225208259
GP visit in last 12 months
GP visit in last 12 months(Participants)CasesControlsTotal
Yes146440536511682951
No45356725971794
BMI
BMI(Participants)CasesControlsTotal
< 18.5 Underweight59312453230463
18.5-24.9 Normal weight46458174953221411
25-29.9 Overweight43720159607203327
30-34.9 Class I obesity213177743298749
35-39.9 Class II obesity87113025838969
40+ Class III obesity53531751522868
Missing19485119473138958
Smoking status
Smoking status(Participants)CasesControlsTotal
Never45,152189,107234259
Current27,173116,895144068
Ex-smoker74,860255,950330810
Passive7701,9042674
Missing30203991442934
Alcohol status
Alcohol status(Participants)CasesControlsTotal
None47083170663217746
Within limits58905226953285858
Excess186606471683376
Harmful2374874311117
Missing23953132695156648

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Momentum Data Ltd
    London, WC1X 8QT, United Kingdom
09

References and documents

Publications

  • Warren RB, Basey V, Lynam A, Curtis C, Ardern-Jones MR. The risk of venous thromboembolism in atopic dermatitis: a matched cohort analysis in UK primary care. Br J Dermatol. 2023 Sep 15;189(4):427-436. doi: 10.1093/bjd/ljad212. PubMed 37418627 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — OPCRD data can be accessed by bone fide researchers for specific research projects, subject to approval by Anonymised Data Ethics \& Protocol Transparency (ADEPT) Committee. The data utilised for this study cannot be made available without such approval.

Supporting information: Study protocol

Time frame: The data will be available subject to approvals for two years after the study publication date

Access criteria: Data sharing is subject to ADEPT committee approval

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2021 to primary completion in Mar 2023, 21 months.

Results were first posted in Dec 2024, 1 year 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2021
First posted
Jul 21, 2021
StartActual
Jun 21, 2021
Primary completionActual
Mar 31, 2023
CompletionActual
Jul 1, 2023
Results first posted
Dec 9, 2024
Last update
Dec 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04969653
Lead sponsor
Momentum Data
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Jul 21, 2021
Start date
Jun 21, 2021
Primary completion
Mar 31, 2023
Completion
Jul 1, 2023
Results posted
Dec 9, 2024
Last update
Dec 9, 2024

Study contacts

Andrew McGovern, MD
study director · Momentum Data Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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