Trial Outcomes & Findings for The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a United Kingdom (UK) Matched Cohort Study (NCT NCT03835780)

Last Updated: 2025-06-11

Results Overview

Number of participants with systemic inflammatory disorders developing VTE (a composite of pulmonary embolism (PE) and deep vein thrombosis (DVT)) compared to population controls.

Recruitment status

COMPLETED

Target enrollment

266890 participants

Primary outcome timeframe

A 20 year analysis period (1999-2018 inclusive)

Results posted on

2025-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Controls Age, gender and primary care practice matched individuals without an existing or incident diagnosis of IBD, RA, or PsA during the study period No intervention: A observation of outcomes in usual practice	People With Ulcerative Colitis All individuals with an existing or incident diagnosis of ulcerative colitis during the study period No intervention: A observation of outcomes in usual practice	People With Crohn's Disease All individuals with an existing or incident diagnosis of Crohn's during the study period No intervention: A observation of outcomes in usual practice	People With Psoriatic Arthritis All individuals with an existing or incident diagnosis of IBD during the study period No intervention: A observation of outcomes in usual practice	People With Rheumatoid Arthritis All individuals with an existing or incident diagnosis of RA during the study period No intervention: A observation of outcomes in usual practice
Overall Study STARTED	213512	14182	9489	6297	23410
Overall Study COMPLETED	213512	14182	9489	6297	23410
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Controls n=213512 Participants Age, gender and primary care practice matched individuals without an existing or incident diagnosis of IBD, RA, or PsA during the study period No intervention: A observation of outcomes in usual practice	People With Ulcerative Colitis n=14182 Participants All individuals with an existing or incident diagnosis of ulcerative colitis during the study period No intervention: A observation of outcomes in usual practice	People With Crohn's Disease n=9489 Participants All individuals with an existing or incident diagnosis of Crohn's disease during the study period No intervention: A observation of outcomes in usual practice	People With Psoriatic Arthritis n=6297 Participants All individuals with an existing or incident diagnosis of IBD during the study period No intervention: A observation of outcomes in usual practice	People With Rheumatoid Arthritis n=23410 Participants All individuals with an existing or incident diagnosis of RA during the study period No intervention: A observation of outcomes in usual practice	Total n=266890 Participants Total of all reporting groups
Age, Continuous	51.7 years STANDARD_DEVIATION 17.8 • n=99 Participants	47.2 years STANDARD_DEVIATION 17.0 • n=107 Participants	41.8 years STANDARD_DEVIATION 16.6 • n=206 Participants	49.2 years STANDARD_DEVIATION 13.8 • n=7 Participants	59.0 years STANDARD_DEVIATION 15.5 • n=31 Participants	49.8 years STANDARD_DEVIATION 6.3 • n=30 Participants
Sex: Female, Male Female	128129 Participants n=99 Participants	7056 Participants n=107 Participants	5193 Participants n=206 Participants	3204 Participants n=7 Participants	16634 Participants n=31 Participants	160216 Participants n=30 Participants
Sex: Female, Male Male	85383 Participants n=99 Participants	7126 Participants n=107 Participants	4296 Participants n=206 Participants	3093 Participants n=7 Participants	6776 Participants n=31 Participants	106674 Participants n=30 Participants
Race/Ethnicity, Customized Asian	9569 Participants n=99 Participants	724 Participants n=107 Participants	347 Participants n=206 Participants	249 Participants n=7 Participants	1114 Participants n=31 Participants	12003 Participants n=30 Participants
Race/Ethnicity, Customized Black	4121 Participants n=99 Participants	127 Participants n=107 Participants	91 Participants n=206 Participants	22 Participants n=7 Participants	403 Participants n=31 Participants	4764 Participants n=30 Participants
Race/Ethnicity, Customized Mixed	1483 Participants n=99 Participants	85 Participants n=107 Participants	67 Participants n=206 Participants	44 Participants n=7 Participants	150 Participants n=31 Participants	1829 Participants n=30 Participants
Race/Ethnicity, Customized Other	1448 Participants n=99 Participants	93 Participants n=107 Participants	54 Participants n=206 Participants	26 Participants n=7 Participants	123 Participants n=31 Participants	1744 Participants n=30 Participants
Race/Ethnicity, Customized White	148832 Participants n=99 Participants	10099 Participants n=107 Participants	6763 Participants n=206 Participants	4727 Participants n=7 Participants	17119 Participants n=31 Participants	187540 Participants n=30 Participants
Race/Ethnicity, Customized Missing	48059 Participants n=99 Participants	3054 Participants n=107 Participants	2167 Participants n=206 Participants	1229 Participants n=7 Participants	4501 Participants n=31 Participants	59010 Participants n=30 Participants
Body mass index Underweight (BMI ≤18.5)	4704 Participants n=99 Participants	368 Participants n=107 Participants	536 Participants n=206 Participants	60 Participants n=7 Participants	607 Participants n=31 Participants	6275 Participants n=30 Participants
Body mass index Normal weight (BMI 18.5-25)	73675 Participants n=99 Participants	5721 Participants n=107 Participants	4225 Participants n=206 Participants	1576 Participants n=7 Participants	7758 Participants n=31 Participants	92955 Participants n=30 Participants
Body mass index Overweight (BMI 25-30)	67076 Participants n=99 Participants	4352 Participants n=107 Participants	2446 Participants n=206 Participants	2131 Participants n=7 Participants	7735 Participants n=31 Participants	83740 Participants n=30 Participants
Body mass index Obese (BMI ≥30)	44303 Participants n=99 Participants	2367 Participants n=107 Participants	1386 Participants n=206 Participants	2071 Participants n=7 Participants	5787 Participants n=31 Participants	55914 Participants n=30 Participants
Body mass index BMI not recorded	23754 Participants n=99 Participants	1374 Participants n=107 Participants	896 Participants n=206 Participants	459 Participants n=7 Participants	1523 Participants n=31 Participants	28006 Participants n=30 Participants
Smoking status Non-Smoker	94985 Participants n=99 Participants	6328 Participants n=107 Participants	3917 Participants n=206 Participants	2522 Participants n=7 Participants	8853 Participants n=31 Participants	116605 Participants n=30 Participants
Smoking status Current Smoker	52035 Participants n=99 Participants	2574 Participants n=107 Participants	2914 Participants n=206 Participants	1519 Participants n=7 Participants	6063 Participants n=31 Participants	65105 Participants n=30 Participants
Smoking status Ex-Smoker	63798 Participants n=99 Participants	5147 Participants n=107 Participants	2551 Participants n=206 Participants	2232 Participants n=7 Participants	8385 Participants n=31 Participants	82113 Participants n=30 Participants
Smoking status Smoking status not recorded	2694 Participants n=99 Participants	133 Participants n=107 Participants	107 Participants n=206 Participants	24 Participants n=7 Participants	109 Participants n=31 Participants	3067 Participants n=30 Participants
Alcohol intake Non-drinker	36623 Participants n=99 Participants	2371 Participants n=107 Participants	1798 Participants n=206 Participants	1035 Participants n=7 Participants	5404 Participants n=31 Participants	47231 Participants n=30 Participants
Alcohol intake Within limits	117939 Participants n=99 Participants	7727 Participants n=107 Participants	4917 Participants n=206 Participants	3508 Participants n=7 Participants	13164 Participants n=31 Participants	147255 Participants n=30 Participants
Alcohol intake Over recommended limits	30096 Participants n=99 Participants	2083 Participants n=107 Participants	1228 Participants n=206 Participants	1067 Participants n=7 Participants	2767 Participants n=31 Participants	37241 Participants n=30 Participants
Alcohol intake Alcoholism	3438 Participants n=99 Participants	217 Participants n=107 Participants	138 Participants n=206 Participants	128 Participants n=7 Participants	340 Participants n=31 Participants	4261 Participants n=30 Participants
Alcohol intake Alcohol level not recorded	25416 Participants n=99 Participants	1784 Participants n=107 Participants	1408 Participants n=206 Participants	559 Participants n=7 Participants	1735 Participants n=31 Participants	30902 Participants n=30 Participants
Index of multiple deprivation (IMD) quintile 1 (most deprived)	29144 Participants n=99 Participants	1689 Participants n=107 Participants	1324 Participants n=206 Participants	803 Participants n=7 Participants	3477 Participants n=31 Participants	36437 Participants n=30 Participants
Index of multiple deprivation (IMD) quintile 2	32323 Participants n=99 Participants	2109 Participants n=107 Participants	1518 Participants n=206 Participants	919 Participants n=7 Participants	3728 Participants n=31 Participants	40597 Participants n=30 Participants
Index of multiple deprivation (IMD) quintile 3	41379 Participants n=99 Participants	2680 Participants n=107 Participants	1901 Participants n=206 Participants	1250 Participants n=7 Participants	4739 Participants n=31 Participants	51949 Participants n=30 Participants
Index of multiple deprivation (IMD) quintile 4	50087 Participants n=99 Participants	3475 Participants n=107 Participants	2186 Participants n=206 Participants	1452 Participants n=7 Participants	5326 Participants n=31 Participants	62526 Participants n=30 Participants
Index of multiple deprivation (IMD) quintile 5 (least deprived)	56209 Participants n=99 Participants	3963 Participants n=107 Participants	2350 Participants n=206 Participants	1720 Participants n=7 Participants	5651 Participants n=31 Participants	69893 Participants n=30 Participants
Index of multiple deprivation (IMD) quintile IMD not recorded	4370 Participants n=99 Participants	266 Participants n=107 Participants	210 Participants n=206 Participants	153 Participants n=7 Participants	489 Participants n=31 Participants	5488 Participants n=30 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	People With Ulcerative Colitis (UC) n=14182 Participants All individuals with an existing or incident diagnosis of UC during the study period No intervention: A observation of outcomes in usual practice	People With Rheumatoid Arthritis n=23410 Participants All individuals with an existing or incident diagnosis of RA during the study period No intervention: A observation of outcomes in usual practice	People With Psoriatic Arthritis n=6297 Participants All individuals with an existing or incident diagnosis of IBD during the study period No intervention: A observation of outcomes in usual practice	Controls n=213512 Participants Age, gender and primary care practice matched individuals without an existing or incident diagnosis of IBD, RA, or PsA during the study period No intervention: A observation of outcomes in usual practice	People With Crohn's Disease n=9489 Participants All individuals with an existing or incident diagnosis of Crohn's disease during hte study period
Risk of Venous Thromboembolism (VTE)	335 Participants	845 Participants	132 Participants	3804 Participants	220 Participants

SECONDARY outcome

Timeframe: A 20 year analysis period (1999-2018 inclusive)

Number of participants with systemic inflammatory disorders developing PE compared to population controls.

Outcome measures

Outcome measures
Measure	People With Ulcerative Colitis (UC) n=14182 Participants All individuals with an existing or incident diagnosis of UC during the study period No intervention: A observation of outcomes in usual practice	People With Rheumatoid Arthritis n=23408 Participants All individuals with an existing or incident diagnosis of RA during the study period No intervention: A observation of outcomes in usual practice	People With Psoriatic Arthritis n=6297 Participants All individuals with an existing or incident diagnosis of IBD during the study period No intervention: A observation of outcomes in usual practice	Controls n=213509 Participants Age, gender and primary care practice matched individuals without an existing or incident diagnosis of IBD, RA, or PsA during the study period No intervention: A observation of outcomes in usual practice	People With Crohn's Disease n=9489 Participants All individuals with an existing or incident diagnosis of Crohn's disease during hte study period
Risk of Pulmonary Embolism (PE)	149 Participants	373 Participants	52 Participants	1737 Participants	98 Participants

SECONDARY outcome

Timeframe: A 20 year analysis period (1999-2018 inclusive)

Number of participants with systemic inflammatory disorders developing DVT compared to population controls.