Trial results from a UK matched cohort study investigating the risk of venous thromboembolism (VTE) in systemic inflammatory disorders were posted on ClinicalTrials.gov on 2025-06-11. The study included a total of 266,890 participants across various inflammatory conditions and a control group.
Background
Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), represents a significant health concern. DVT occurs when a blood clot forms in a deep vein, typically in the legs, while PE is a potentially life-threatening condition where a clot travels to the lungs. The risk of developing DVT and PE is known to be elevated in individuals with systemic inflammatory disorders. These include inflammatory bowel diseases such as Crohn's disease and ulcerative colitis, as well as rheumatoid arthritis and psoriatic arthritis. Understanding the incidence of these thrombotic events within affected populations is crucial for patient management and risk assessment.
Trial design
This completed matched cohort study enrolled a substantial cohort of 266,890 participants. The study focused on the risk of venous thromboembolism, deep vein thrombosis, and pulmonary embolism in individuals with systemic inflammatory disorders. Conditions investigated included Venous Thromboses, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Rheumatoid Arthritis, Ulcerative Colitis, Psoriatic Arthritis, and Crohn's Disease. The study design involved comparing participants with these inflammatory conditions to a matched control group.
Key results
The study reported the following counts of participants who experienced venous thromboembolism (VTE), pulmonary embolism (PE), and deep vein thrombosis (DVT) across the different groups:
- Risk of Venous Thromboembolism (VTE):
- People With Ulcerative Colitis (UC): 335 Participants
- People With Rheumatoid Arthritis: 845 Participants
- People With Psoriatic Arthritis: 132 Participants
- People With Crohn's Disease: 220 Participants
- Controls: 3804 Participants
- Risk of Pulmonary Embolism (PE):
- People With Ulcerative Colitis (UC): 149 Participants
- People With Rheumatoid Arthritis (RA): 373 Participants
- People With Psoriatic Arthritis (PsA): 52 Participants
- People With Crohn's Disease (CD): 98 Participants
- Controls: 1737 Participants
- Risk of Deep Vein Thrombosis (DVT):
- People With Ulcerative Colitis (UC): 207 Participants
- People With Rheumatoid Arthritis (RA): 542 Participants
What this means
The posted results provide specific participant counts for venous thromboembolism, pulmonary embolism, and deep vein thrombosis events in a large UK cohort of individuals with Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis, compared to controls. For patients with Crohn's disease, 220 participants experienced VTE and 98 experienced PE. Data for deep vein thrombosis specifically for the Crohn's disease group was not listed in the key measurements. These counts highlight the occurrence of these thrombotic events within these patient populations, reinforcing the known association between systemic inflammation and increased VTE risk. While the data provides raw counts, it does not include comparative analyses or risk ratios, which would offer further insights into the relative risk compared to the control group.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study titled "The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a United Kingdom (UK) Matched Cohort Study" were posted on 2025-06-11 on clinicaltrials.gov.