Premature Endothelial DysfunctionNCT01499732
Exploratory Trial to Evaluate Premature Endothelial Dysfunction in Early Rheumatoid Arthritis(RA)Compared to Patients With Established RA, and Normal Subjects
An observational study of Premature Endothelial Dysfunction and Rheumatoid Arthritis, run by Orrin M Troum, M.D. and Medical Associates at 1 site in United States.
Trial summary
Premature Endothelial Dysfunction is present in patients with early rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Endothelial Dysfunction, Rheumatoid Arthritis, Healthy
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Five adults (>18 years of age), male or non pregnant, non nursing female with active early rheumatoid arthritis (<2 years), five adults, male or non-pregnant, non nursing female with active established rheumatoid arthritis (>2 years), and five healthy adults, male or non-pregnant, non nursing female without RA are to be enrolled.
Who may be able to join
- Group 1
- Subjects currently experiencing active early RA (duration of symptoms ≤ 2 years) according to the 2010 ACR/EULAR criteria for the diagnosis of RA at screening.
- Subjects with early RA must be drug naïve (no prior treatment with traditional disease-modifying antirheumatic drugs (DMARDs), or biologic response modifying agents).
- Group 2
- Subjects currently experiencing active established RA (duration of symptoms ≥ 2 years) according to the 2010 ACR/EULAR criteria for the diagnosis of RA at screening.
- Subjects with active established RA currently receiving methotrexate (MTX), must have received it for at least 12 weeks, and at a stable dose (≥15mg/week) for at least 6 weeks prior to screening. They must be biologic drug naïve. These subjects must receive at least 5 mg oral folic acid weekly.
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- Subjects diagnosed with RA must be seropositive with documented rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti CCP) positivity. If a documented history of RF or anti CCP positivity is not available, RF and anti CCP titers will be obtained at screening Group 3
- Healthy subjects without RA.
- All subjects must have sitting diastolic BP ≤90 mm Hg and/or sitting systolic BP ≤ 140 at screening
- Subjects must have fasting plasma glucose (FPG) of ≤ 100 mg/dL.
- If subjects with established RA are receiving an oral corticosteroid, the dose must be ≤7 mg/day prednisone (or equivalent) and stable for at least 28 days prior to screening.
- Subjects able and willing to give written informed consent and comply with the requirements of the study protocol. Informed consent must be obtained prior to any study-related procedures.
- A copy of the signed informed consent form must be given to the subject
- Patients must have a BMI of less than 42
Who cannot join
- Major surgery (including joint surgery) within 8 weeks prior to screening.
- Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome). Prior history of or current inflammatory joint disease other than RA (gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis and psoriatic arthritis)
- Functional class IV as defined by ACR Classification of Functional Status in RA
- Current treatment with any traditional DMARDs other than MTX within 4 weeks before the screening visit (For subjects with established RA). Current or prior use of Leflunomide will be exclusionary.
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
- Exposure to any Biologic Response Modifying Agent for RA
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- Intraarticular or parenteral corticosteroids within 6 weeks prior to screening (For subjects with established RA)
- Exclusionary laboratory: Serum creatinine >2 mg/dL, ALT or AST > 2.0 x ULN, total bilirubin > 2.0 x ULN, platelet count <100 x 10⁹ /L, hemoglobin < 8.5 g/dL, WBC count < 1,000/mm³ , absolute neutrophil count < 1,000/ mm³, absolute lymphocyte count < 500/mm³, triglycerides >400 mg/dL, Serum potassium <3.5 or >5.5 mEq /L without medication, serum albumin <2.5 g/dL, Gamma GT 3.0 x UNL
- Smokers (use of tobacco products in the recent past < 6 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports cigarette use or has a urine cotinine greater than 200 ng/mL.
- Pregnant women or nursing mothers
- Females of child bearing potential who are not using reliable means of contraception
- Evidence of serious uncontrolled concomitant cardiovascular (including known CAD, HTN, or hyperlipidemia), nervous system, pulmonary, renal, hepatic, endocrine or GI disease.
- Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel syndrome, where flares are commonly treated with corticosteroids.
- History or presence of severe bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- History of cardiovascular abnormalities including myocardial infarction, angina pectoris, hypertensive encephalopathy, stroke, transient ischemic attack, valvular heart disease, ventricular arrhythmia A-V block, atrial fibrillation or cardiac revascularization/angioplasty. Symptoms or clinical evidence of congestive heart failure or known left ventricular ejection fraction < 40%.
- Medical history of clinically significant ECG abnormalities, including history of a prolonged QT-interval syndrome.
- History of autonomic dysfunction
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections such as atypical mycobacterial disease, hepatitis B and C, HIV, herpes zoster, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- Any malignancy except for skin cancer (basal cell or squamous cell) diagnosed within the previous 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Orrin M. Troum, MD and Medical Associates
Santa Monica, California, 90404
About this study
Official title: An Exploratory Trial to Evaluate Premature Endothelial Dysfunction, as Measured by Positron Emission Tomography (PET) Scan With Cold Pressor Test (CPT), in Patients With Early Rheumatoid Arthritis (RA) Compared to Patients With Established RA, and Normal Subjects. Additionally, the Relationship Between the PET Scan Findings and the Inflammatory, Cardiovascular Risk, and Endothelial Dysfunction Biomarkers Will be Analyzed
Premature Endothelial Dysfunction is present in patients with early rheumatoid arthritis.
- Keywords
- Premature endothelial dysfunction, Early Rheumatoid Arthritis, established rheumatoid arthritis, Premature endothelial dysfunction in early rheumatoid arthritis, Premature endothelial dysfunction in established rheumatoid arthritis, Endothelial function in healthy subjects
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early Rheumatoid Arthritis | Subjects currently experiencing active early rheumatoid arthritis (duration of symptoms < or = 2 years) according to the 2010 ACR/EULAR criteria for the diagnosis of RA at screening. Must be drug naive (no prior treatment with traditional disease-modifying antirrheumatic drugs (DMARDs), or biologic response modifying agents) | |
| Healthy subjects without rheumatoid arthritis | Healthy subjects without rheumatoid arthritis | |
| Established Rheumatoid Arthritis | Subjects currently experiencing active established rheumatoid arthritis (duration fo symptoms > or = 2 years) according to the 2010 ACR/EULAR criteria at screening. Subjects with active established RA currently receiving methotrexate, must have received it for at least 12 weeks, and at a stable dose (> or = 15 mg/week) for at least 6 weeks prior to screening. They must be biologic naive, and must recieve at least 5mg oral folic acid weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evalute the presence of endothelial dysfunction in patients with rheumatoid arthritis utilizing PET/CT scan with cold pressor test.
Endothelial dysfunction will be defined as myocardial blood flow (MBF)during cold pressor test (CPT)of less than or equal to 40%
Measured: 5 months
Secondary outcomes (1)
To evaluate the relationship between PET Scan findings and biomarkers (inflammatory, cardiovascular risk and endothelial dysfunction), and outcome measures
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Endothelial DysfunctionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orrin M Troum, M.D. and Medical Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Orrin M Troum, MD, Principal investigator, Orrin M. Troum, MD and Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499732
- Sponsor's protocol ID
- IM101-320
- Status last verified
- May 2013
- First submitted
- 15 Dec 2011
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Trial to Evaluate Premature Endothelial Dysfunction, as Measured by Positron Emission Tomography (PET) Scan With Cold Pressor Test (CPT), in Patients With Early Rheumatoid Arthritis (RA) Compared to Patients With Established RA, and Normal Subjects. Additionally, the Relationship Between the PET Scan Findings and the Inflammatory, Cardiovascular Risk, and Endothelial Dysfunction Biomarkers Will be Analyzed
- ClinicalTrials.gov ID
- NCT01499732
- Acronym / sponsor ID
- IM101-320
- Keywords
- Premature endothelial dysfunction, Early Rheumatoid Arthritis, established rheumatoid arthritis, Premature endothelial dysfunction in early rheumatoid arthritis, Premature endothelial dysfunction in established rheumatoid arthritis, Endothelial function in healthy subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Orrin M Troum, M.D. and Medical AssociatesUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Premature Endothelial Dysfunction is present in patients with early rheumatoid arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Rheumatoid Arthritis | – | –Subjects currently experiencing active early rheumatoid arthritis (duration of symptoms < or = 2 years) according to the 2010 ACR/EULAR criteria for the diagnosis of RA at screening. Must be drug naive (no prior treatment with traditional disease-modifying antirrheumatic drugs (DMARDs), or biologic response modifying agents) |
| Healthy subjects without rheumatoid arthritis | – | –Healthy subjects without rheumatoid arthritis |
| Established Rheumatoid Arthritis | – | –Subjects currently experiencing active established rheumatoid arthritis (duration fo symptoms > or = 2 years) according to the 2010 ACR/EULAR criteria at screening. Subjects with active established RA currently receiving methotrexate, must have received it for at least 12 weeks, and at a stable dose (> or = 15 mg/week) for at least 6 weeks prior to screening. They must be biologic naive, and must recieve at least 5mg oral folic acid weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Five adults (>18 years of age), male or non pregnant, non nursing female with active early rheumatoid arthritis (<2 years), five adults, male or non-pregnant, non nursing female with active established rheumatoid arthritis (>2 years), and five healthy adults, male or non-pregnant, non nursing female without RA are to be enrolled.
Key inclusion criteria (14 listed)
- Group 1
- Subjects currently experiencing active early RA (duration of symptoms ≤ 2 years) according to the 2010 ACR/EULAR criteria for the diagnosis of RA at screening.
- Subjects with early RA must be drug naïve (no prior treatment with traditional disease-modifying antirheumatic drugs (DMARDs), or biologic response modifying agents).
- Group 2
- Subjects currently experiencing active established RA (duration of symptoms ≥ 2 years) according to the 2010 ACR/EULAR criteria for the diagnosis of RA at screening.
Key exclusion criteria (19 listed)
- Major surgery (including joint surgery) within 8 weeks prior to screening.
- Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome). Prior history of or current inflammatory joint disease other than RA (gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis and psoriatic arthritis)
- Functional class IV as defined by ACR Classification of Functional Status in RA
- Current treatment with any traditional DMARDs other than MTX within 4 weeks before the screening visit (For subjects with established RA). Current or prior use of Leflunomide will be exclusionary.
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evalute the presence of endothelial dysfunction in patients with rheumatoid arthritis utilizing PET/CT scan with cold pressor test.
Time frame: 5 months
Endothelial dysfunction will be defined as myocardial blood flow (MBF)during cold pressor test (CPT)of less than or equal to 40%
1 secondary outcome
To evaluate the relationship between PET Scan findings and biomarkers (inflammatory, cardiovascular risk and endothelial dysfunction), and outcome measures
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
Related trials for Premature Endothelial Dysfunction
Recruiting
ACEs, SIRT1, and Premature Vascular Aging in Humans
Adverse Childhood Experiences, Endothelial Dysfunction
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.
Orrin M Troum, MD principal investigator
Orrin M. Troum, MD and Medical Associates
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 Premature Endothelial Dysfunction and Rheumatoid Arthritis, run by Orrin M Troum, M.D. and Medical Associates 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 14 inclusion and 19 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 8 May 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evalute the presence of endothelial dysfunction in patients with rheumatoid arthritis utilizing PET/CT scan with cold pressor test. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2013.