Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis (NCT03254589) | Clinical Trial Compass
CompletedPhase 4
Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis
Australia124 participantsStarted 2017-10-01
Plain-language summary
The investigators will study the effects of methotrexate on blood pressure, arterial stiffness and endothelial function in patients with rheumatoid arthritis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria.
* Age ≥18 years.
* Written informed consent, dated and signed before initiating any study-related procedure.
Exclusion Criteria:
* Contraindication to MTX or sulfasalazine.
* Patient who cannot be followed during 6 months.
* Active alcohol or substance abuse within the last 12 months.
* Participation in a clinical trial within 3 months prior to the start of the study.
* Body mass index \>35 Kg/m2.
* Secondary causes of hypertension.
* Grade 2 (moderate) or 3 (severe) hypertension: clinic blood pressure \>160/100 mm Hg.
* Resistant hypertension: clinical blood pressure ≥140/90 mm Hg despite concurrent use of three antihypertensive agents of different classes, one of which is a diuretic.
* Clinical systolic blood pressure \<100 mm Hg or history of symptomatic orthostatic hypotension.
* Cardiovascular event, procedure, or hospitalization for unstable angina with the last 6 months.
* Atrial fibrillation.
* Heart failure.
* Treatment with nitrates.
* Estimated glomerular filtration rate (eGFR) \<45 mL/min.
* Diagnosis of polycystic kidney disease.
* Glomerulonephritis treated with or likely to be treated with immunosuppressant drugs
* Uncontrolled diabetes with HbA1c \>9.0% (\>75 mmol/mol).
* Uncontrolled dyslipidaemia with total serum cholesterol \>7.5 mmol/L or triglycerides \>5.6 mmol/L.
* Clinical diagnosis of dementia, treatment with medications for dementia or, in the opinion of …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in peripheral systolic blood pressure
Timeframe: Change from baseline peripheral systolic blood pressure at 6 months