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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL127118 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with active RA who are biologic naive
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| Name | Affiliation | Role |
|---|---|---|
| Katherine P Liao, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38686879 | Derived | 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. | |
| 35657008 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tumor Necrosis Factor Inhibitor | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | n=1 subject enrolled, however changed their mind during the baseline study visit. Thus, enrolled n=74 and studied is n=73. | Posted | Mean | Standard Deviation | ratio | 24 weeks |
|
24 weeks
All adverse events were discussed with the PI who then helped determine the level of severity for each AE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Certolizumab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fracture | Injury, poisoning and procedural complications | Systematic Assessment | s/p fall, fracture of right foot and left fibula |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine P. Liao, MD, MPH | Brigham and Women's Hospital | 617-732-5000 | kliao@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2023 | Dec 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
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| Derived |
| Weber 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 74 |
| 2 |
| 74 |
| 23 |
| 74 |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment | Evaluated in emergency room and discharged |
|
| otitis media | Infections and infestations | Systematic Assessment |
|
| tooth infection | Infections and infestations | Systematic Assessment |
|
| urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| sinusitis | Infections and infestations | Systematic Assessment |
|
| INR increased | Investigations | Systematic Assessment |
|
| papulopustular rash | Infections and infestations | Systematic Assessment | shingles |
|
| dehydration | Metabolism and nutrition disorders | Systematic Assessment | Possible food poisoning |
|
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| rash | Infections and infestations | Systematic Assessment |
|
| thromboembolic event | Blood and lymphatic system disorders | Systematic Assessment | DVT s/p TKR |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| autoimmune disorder | Immune system disorders | Systematic Assessment | psoriasis |
|
| eye infection | Infections and infestations | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| periodontal disease | Gastrointestinal disorders | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| autoimmune disorder | Skin and subcutaneous tissue disorders | Systematic Assessment | psoriasis |
|
| gum infection | Infections and infestations | Systematic Assessment |
|
| colitis | Gastrointestinal disorders | Systematic Assessment |
|
| pulmonary nodule | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| bone infection | Infections and infestations | Systematic Assessment | jaw |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007128 |
| Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |