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

NCT03835780 | Completed Results

• 1 other identifier: P004
• Study Type: observational
• Target: 266,890
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboses; Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Rheumatoid Arthritis; Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  A 20 year analysis period (1999-2018 inclusive)

Secondary Outcomes (2)

• Risk of Pulmonary Embolism (PE)

  A 20 year analysis period (1999-2018 inclusive)

• Risk of Deep Vein Thrombosis (DVT)

  A 20 year analysis period (1999-2018 inclusive)

Study Arms (4)

People with inflammatory bowel disease

All individuals with an existing or incident diagnosis of IBD during the study period

Other: No intervention

People with rheumatoid arthritis

All individuals with an existing or incident diagnosis of RA during the study period

Other: No intervention

People with psoriatic arthritis

All individuals with an existing or incident diagnosis of IBD during the study period

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

Other: No intervention

Interventions

No intervention OTHER

A observation of outcomes in usual practice

Controls; People with inflammatory bowel disease; People with psoriatic arthritis; People with rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

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

Sponsors & Collaborators

• Momentum Data: lead
• Pfizer: collaborator
• University of Surrey: collaborator

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33597152 DERIVED

• Galloway 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.

  PMID: 32994362 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Venous Thromboembolism; Pulmonary Embolism; Arthritis, Rheumatoid; Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Lung Diseases; Respiratory Tract Diseases; Embolism; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Results Point of Contact

• Title: Maya H Buch
• Organization: Centre for Musculoskeletal Research

maya.buch@manchester.ac.uk

+441613066000

Study Officials

• Andrew McGovern, MD

  Momentum Data

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 11, 2019
• Study Start: February 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available subject to approval for two years after the study publication date.
• Access Criteria: Data sharing is subject to required data protection training and other requirements.

Locations

GB (1)