Status:
COMPLETED
Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis
Lead Sponsor:
Flinders University
Collaborating Sponsors:
University of South Australia
medac GmbH
Conditions:
Rheumatoid Arthritis
Stiffness, Aortic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators will study the effects of methotrexate on blood pressure, arterial stiffness and endothelial function in patients with rheumatoid arthritis.
Detailed Description
Patients with rheumatoid arthritis have an increased risk of stroke and heart attack when compared to the rest of the population. Recent studies have shown that methotrexate, a disease-modifying antir...
Eligibility Criteria
Inclusion
- 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
- 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 the study staff, the participant is cognitively unable to follow the protocol.
- Other medical, psychiatric, or behavioural factors that in the judgment of the study staff may interfere with study participation.
- Cancer diagnosed and treated within the past 2 years that, in the judgment of the study staff, would compromise a participant's ability to comply with the protocol and complete the study.
- Any organ transplant.
- Pregnancy, currently trying to become pregnant, or of child bearing potential and not using birth control.
- Significant illness within 2 weeks of study start.
- Patients with an unstable active medical condition that could impair evaluation of study results.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03254589
Start Date
October 1 2017
End Date
December 31 2023
Last Update
February 26 2025
Active Locations (1)
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1
Southern Adelaide Local Health Network
Bedford Park, South Australia, Australia, 5042