Rheumatoid Arthritis Clinical Trial
Official title:
The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a UK Matched Cohort Study
NCT number | NCT03835780 |
Other study ID # | P004 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2019 |
Est. completion date | December 1, 2019 |
Verified date | January 2020 |
Source | Momentum Data |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 266890 |
Est. completion date | December 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Momentum Data Ltd | London |
Lead Sponsor | Collaborator |
---|---|
Momentum Data | Pfizer, University of Surrey |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to venous thromboembolism (VTE) | Time to VTE (a composite of PE and DVT) in individuals with systemic inflammatory disorders compared to population controls. | A 20 year analysis period (1999-2018 inclusive) | |
Secondary | Time to pulmonary embolism (PE) | Time to PE in individuals with systemic inflammatory disorders compared to population controls. | A 20 year analysis period (1999-2018 inclusive) | |
Secondary | Time to deep vein thrombosis (DVT) | Time to DVT in individuals with systemic inflammatory disorders compared to population controls. | A 20 year analysis period (1999-2018 inclusive) |
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