NCT03254589CompletedPhase 4
Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 26 Feb 2025
Brief summary (registry, in English)
The investigators will study the effects of methotrexate on blood pressure, arterial stiffness and endothelial function in patients with rheumatoid arthritis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 124 (actual)
- First submitted
- 16 Aug 2017
- Start date
- 1 Oct 2017
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Flinders University
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03254589
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 124
- From 1 Oct 2017 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in a clinical trial within 3 months prior to the start of the study.
- 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.
- Treatment with nitrates.
- Glomerulonephritis treated with or likely to be treated with immunosuppressant drugs
- 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.
- Any organ transplant.
Other illness
- Secondary causes of hypertension.
- Grade 2 (moderate) or 3 (severe) hypertension: clinic blood pressure \>160/100 mm Hg.
- 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.
- Heart failure.
- Diagnosis of polycystic kidney disease.
- 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.
- Significant illness within 2 weeks of study start.
- Patients with an unstable active medical condition that could impair evaluation of study results.
Lab values
- Estimated glomerular filtration rate (eGFR) \<45 mL/min.
- 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.
Other
- Contraindication to MTX or sulfasalazine.
- Patient who cannot be followed during 6 months.
- Active alcohol or substance abuse within the last 12 months.
- Body mass index \>35 Kg/m2.
- Atrial fibrillation.
- Pregnancy, currently trying to become pregnant, or of child bearing potential and not using birth control.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Southern Adelaide Local Health Network Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.