Trial Outcomes & Findings for Lipids, Inflammation, and CV Risk in RA (NCT NCT02714881)
NCT ID: NCT02714881
Last Updated: 2026-01-21
Results Overview
The coronary flow reserve (CFR) is the ratio of myocardial blood flow at stress over myocardial blood flow at rest. This marker is ideally suited as the cardiac imaging biomarker for both a measure of coronary vasomotor function as well as surrogate CV outcome in RA.
Recruitment status
COMPLETED
Target enrollment
74 participants
Primary outcome timeframe
24 weeks
Results posted on
2026-01-21
Participant Flow
Participant milestones
| Measure |
Tumor Necrosis Factor Inhibitor
Subjects who fulfil the inclusion criteria and are about to initiate a tumor necrosis factor inhibitor (TNFi) as part of usual care.
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lipids, Inflammation, and CV Risk in RA
Baseline characteristics by cohort
| Measure |
Tumor Necrosis Factor Inhibitor
n=73 Participants
Subjects who are about to initiate a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. They will have measurements including routine lipids, advanced lipoproteins, and coronary flow reserve (CFR) before and after TNFi.
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 11 • n=37 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: n=1 subject enrolled, however changed their mind during the baseline study visit. Thus, enrolled n=74 and studied is n=73.
The coronary flow reserve (CFR) is the ratio of myocardial blood flow at stress over myocardial blood flow at rest. This marker is ideally suited as the cardiac imaging biomarker for both a measure of coronary vasomotor function as well as surrogate CV outcome in RA.
Outcome measures
| Measure |
Tumor Necrosis Factor Inhibitor
n=73 Participants
Subjects who are about to start on a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. They will have measurements including routine lipids, advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.
|
|---|---|
|
Coronary Flow Reserve
|
2.65 ratio
Standard Deviation 0.56
|
Adverse Events
Tumor Necrosis Factor Inhibitor
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tumor Necrosis Factor Inhibitor
n=74 participants at risk
Subjects who are about to initiate a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. Subjects will undergo measurements for inflammatory biomarkers, lipids and advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.
Certolizumab
|
|---|---|
|
Injury, poisoning and procedural complications
fracture
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
Upper respiratory infection
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
Other adverse events
| Measure |
Tumor Necrosis Factor Inhibitor
n=74 participants at risk
Subjects who are about to initiate a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. Subjects will undergo measurements for inflammatory biomarkers, lipids and advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.
Certolizumab
|
|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
otitis media
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
tooth infection
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
sinusitis
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Investigations
INR increased
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
papulopustular rash
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Metabolism and nutrition disorders
dehydration
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Ear and labyrinth disorders
Ear pain
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
upper respiratory infection
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
rash
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Blood and lymphatic system disorders
thromboembolic event
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Gastrointestinal disorders
nausea
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Immune system disorders
autoimmune disorder
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
eye infection
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Gastrointestinal disorders
diarrhea
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Gastrointestinal disorders
periodontal disease
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
urinary tract infection
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Injury, poisoning and procedural complications
fall
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Skin and subcutaneous tissue disorders
autoimmune disorder
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
gum infection
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Gastrointestinal disorders
colitis
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary nodule
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
|
Infections and infestations
bone infection
|
1.4%
1/74 • 24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
|
Additional Information
Katherine P. Liao, MD, MPH
Brigham and Women's Hospital
Phone: 617-732-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place