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Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis
The investigators will study the effects of methotrexate on blood pressure, arterial stiffness and endothelial function in patients with rheumatoid arthritis.
Study details:
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 antirheumatic drug (DMARDs) commonly prescribed for rheumatoid arthritis, reduces this risk. However, the mechanisms responsible for the protective effects of methotrexate on the heart and the brain are unknown.
The investigators have recently completed an observational study in participants with rheumatoid arthritis treated with either methotrexate or with other DMARDs. Participants on methotrexate had lower blood pressure and 'healthier' blood vessels than participants treated with other DMARDs. These differences were maintained over a period of 8 months.
These results suggest that methotrexate lowers blood pressure and exerts salutary effects on blood vessels, which might explain the reduced risk of stroke and heart attack with this drug. However, the observational nature of this study does not allow establishing a clear cause-effect relationship between methotrexate treatment and the observed changes in blood pressure and blood vessels. In order to address this issue, the investigators will recruit participants that have been recently diagnosed with rheumatoid arthritis and are about to start treatment with either methotrexate (Group 1) or another DMARD (Group 2).
Then, the investigators will assess their blood pressure and blood vessels for 6 months. The investigators will use an injectable (subcutaneous) form of methotrexate because this might provide better effects on blood pressure and blood vessels. The investigators will also study a third group (Group 3) of rheumatoid arthritis participants already on treatment (\> 1 year) with oral methotrexate, with or without other DMARDs.
They will be switched to subcutaneous methotrexate, but continuing all their other medications, for 6 months to see whether the subcutaneous form can further reduce blood pressure and provide additional salutary effects on blood vessels. Finally, the investigators will study a fourth group (Group 4) of participants with rheumatoid arthritis already on treatment (\> 1 year) with DMADRs other than methotrexate who will continue with the same medications for 6 months, to assess possible fluctuations in blood pressure and blood vessel markers over time. Each participant will attend three study visits (baseline, 1 and 6 months), each lasting between 60 and 90 min.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2017-10-01
Primary completion: 2023-12-31
Study completion finish: 2024-12-31
Study type
TREATMENT
Phase
PHASE4
Trial ID
NCT03254589
Intervention or treatment
DRUG: Methotrexate
DRUG: Sulfasalazine
DRUG: Other DMARDs
Conditions
- • Rheumatoid Arthritis
- • Stiffness, Aortic
- • Endothelial Dysfunction
- • Cardiovascular Risk Factor
Find a site
Closest Location:
Southern Adelaide Local Health Network
Research sites nearby
Select from list below to view details:
Southern Adelaide Local Health Network
Bedford Park, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Group 1
| DRUG: Methotrexate
|
ACTIVE_COMPARATOR: Group 2
| DRUG: Sulfasalazine
|
EXPERIMENTAL: Group 3
| DRUG: Methotrexate
|
ACTIVE_COMPARATOR: Group 4
| DRUG: Other DMARDs
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change in peripheral systolic blood pressure | Change in peripheral systolic blood pressure | Change from baseline peripheral systolic blood pressure at 6 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Change in peripheral and central blood pressure | Change in peripheral and central blood pressure | Change from baseline peripheral and central blood pressure at 6 months |
Change in arterial stiffness | Change in pulse wave velocity | Change from baseline pulse wave velocity at 6 months |
Change in arterial wave reflection | Change in augmentation index | Change from baseline augmentation index at 6 months |
Change in adenosine | Change in adenosine concentrations | Change from baseline adenosine concentrations at 6 months |
Change in arginine metabolites | Change in ADMA concentrations | Change from baseline ADMA concentrations at 6 months |
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