Rheumatoid ArthritisLiiRANCT02714881
Lipids, Inflammation, and CV Risk in RA
An observational study of Rheumatoid Arthritis and Cardiovascular Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this study was to examine the relationship between inflammation, lipids, and cardiovascular risk in rheumatoid arthritis. The central hypothesis is that reducing inflammation will reduce cardiovascular risk as measured by coronary flow reserve. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis, Cardiovascular Disease
- What is being tested?
- Certolizumab
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2016to 21 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with active RA who are biologic naive
Who may be able to join
- RA diagnosed by a rheumatologist
- Fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria for RA
- Age>35
- Active RA as defined by treating rheumatologist
- Biologic DMARD naive
Who cannot join
- Patients on statin or PCSK9 inhibitor therapy
- Corticosteroid therapy >10mg prednisone or its equivalent as a maintenance treatment
- Pregnancy
- Unstable angina (chest pain) or shortness of breath
- Severe valvular heart disease
- Myocarditis
Show all 10Show fewer
- Pericarditis
- Asthma with active wheezing
- History of lymphoproliferative disease or melanoma (stage two or higher), active malignancy, or cancer treatment in the last 5 years
- Active infectious disease (HIV, Tuberculosis, or Hepatitis B/C)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis
The objective of this study was to examine the relationship between inflammation, lipids, and cardiovascular risk in rheumatoid arthritis. The central hypothesis is that reducing inflammation will reduce cardiovascular risk as measured by coronary flow reserve. Additionally, we hypothesized that lipid levels may have a weaker correlation with CV risk compared to the general population.
- Conditions
- Rheumatoid Arthritis, Cardiovascular Disease
- Being tested
- Certolizumab
- Medical subject headings
- Arthritis, Rheumatoid, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CertolizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Tumor necrosis factor inhibitor | 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. Receives: Drug: Certolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Flow Reserve
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study start17 Oct 2016
- Primary completion14 Dec 2020
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Katherine P Liao, Brigham and Women's Hospital
- Investigators
- Katherine P Liao, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714881
- Sponsor's protocol ID
- 2016P000219
- Other IDs
- R01HL127118
- Acronym
- LiiRA
- Status last verified
- Dec 2025
- First submitted
- 14 Mar 2016
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Weber B, Weisenfeld D, Massarotti E, Seyok T, Cremone G, Lam E, Golnik C, Brownmiller S, Liu F, Huang S, Todd DJ, Coblyn JS, Weinblatt ME, Cai T, Dahal K, Kohler M, Yinh J, Barrett L, Solomon DH, Plutzky J, Schelbert HR, Campisi R, Bolster MB, Di Carli M, Liao KP. Interplay Between Systemic Inflammation, Myocardial Injury, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis: Results From the LiiRA Study. J Am Heart Assoc. 2024 May 7;13(9):e030387. doi: 10.1161/JAHA.123.030387. Epub 2024 Apr 30.
PubMed 38686879Weber B, Weisenfeld D, Seyok T, Huang S, Massarotti E, Barrett L, Bibbo C, Solomon DH, Plutzky J, Bolster M, Di Carli M, Liao KP. Relationship Between Risk of Atherosclerotic Cardiovascular Disease, Inflammation, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis. J Am Heart Assoc. 2022 Jun 7;11(11):e025467. doi: 10.1161/JAHA.121.025467. Epub 2022 Jun 3. No abstract available.
PubMed 35657008
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02714881
- Acronym / sponsor ID
- LiiRA / 2016P000219
- Conditions
- Rheumatoid Arthritis, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to examine the relationship between inflammation, lipids, and cardiovascular risk in rheumatoid arthritis. The central hypothesis is that reducing inflammation will reduce cardiovascular risk as measured by coronary flow reserve. Additionally, we hypothesized that lipid levels may have a weaker correlation with CV risk compared to the general population.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor necrosis factor inhibitor | – | Drug: CertolizumabSubjects 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. |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with active RA who are biologic naive
Key inclusion criteria (5 listed)
- RA diagnosed by a rheumatologist
- Fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria for RA
- Age>35
- Active RA as defined by treating rheumatologist
- Biologic DMARD naive
Key exclusion criteria (10 listed)
- Patients on statin or PCSK9 inhibitor therapy
- Corticosteroid therapy >10mg prednisone or its equivalent as a maintenance treatment
- Pregnancy
- Unstable angina (chest pain) or shortness of breath
- Severe valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab | Drug | Tumor necrosis factor inhibitor |
Primary outcome
Coronary Flow Reserve
Time frame: 24 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38686879Weber B, Weisenfeld D, Massarotti E, Seyok T, Cremone G, Lam E, Golnik C, Brownmiller S, Liu F, Huang S, Todd DJ, Coblyn JS, Weinblatt ME, Cai T, Dahal K, Kohler M, Yinh J, Barrett L, Solomon DH, Plutzky J, Schelbert HR, Campisi R, Bolster MB, Di Carli M, Liao KP. Interplay Between Systemic Inflammation, Myocardial Injury, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis: Results From the LiiRA Study. J Am Heart Assoc. 2024 May 7;13(9):e030387. doi: 10.1161/JAHA.123.030387. Epub 2024 Apr 30.
- Derived from this study: PubMed 35657008Weber B, Weisenfeld D, Seyok T, Huang S, Massarotti E, Barrett L, Bibbo C, Solomon DH, Plutzky J, Bolster M, Di Carli M, Liao KP. Relationship Between Risk of Atherosclerotic Cardiovascular Disease, Inflammation, and Coronary Microvascular Dysfunction in Rheumatoid Arthritis. J Am Heart Assoc. 2022 Jun 7;11(11):e025467. doi: 10.1161/JAHA.121.025467. Epub 2022 Jun 3. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine P Liao, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Cardiovascular Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Flow Reserve (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02714881, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.