None listed
Conditions
Brief summary
Methotrextate (MTX) remains the most commonly used drug for the treatment of rheumatoid arthritis (RA). The exact mecahnism of action of MTX remains unlear but it acts as a folate antagonist. Thus it is recommended that all patients receiving MTX also receive at least 5mg/week of folic acid in an effort to reduce occurrence of MTX associated adverse effects. Previous research has suggested that supplemental folic acid has no detrimental effects on control of RA. However we have shown that patients with higher red blood cell (RBC) concentrations of folic acid have more active RA compared to those with lower RBC concentrations. we now wish to determine whether reducing the amount of extra folic acid patients receive will help improve disease control in those patients receiving MTX.
Interventions
All patients in this trial will be taking methotrexate (MTX). The dose will vary between patients depending on their disease activity and the decision of their prescribing physician.
The exact mechanism of action of methotrexate remains unclear but it acts as a folate antagonist. Therefore all patients receiving methotrexate receive 5mg/week of oral folic acid in an effort to reduce occurrence of methotrexate associated adverse effects. Patients will continue taking folate for as long as they r
All patients in this trial will be taking methotrexate (MTX). The dose will vary between patients depending on their disease activity and the decision of their prescribing physician. The exact mechanism of action of methotrexate remains unclear but it acts as a folate antagonist. Therefore all patients receiving methotrexate receive 5mg/week of oral folic acid in an effort to reduce occurrence of methotrexate associated adverse effects. Patients will continue taking folate for as long as they remain on methotrexate (MTX). This may be long term if it is providing adequate control of their rheumatoid arthritis (RA). The intervention is a reduced dose (0.8mg/weekly) of oral folate as a supplement to methotrexate.
Sponsors
Associate Professor Lisa Stamp
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: 1. Male or female, aged >18 yrs, with RA as defined by the American Rheumatology Association Criteria 2. Methotrexate either as monotherapy or combination therapy for at least three months with a stable oral dose of MTX between 5 to 25mg weekly over the preceding four weeks 3. Inadequate response to MTX as defined by DAS28>3.2 4. Able and willing to give written informed consent and to comply with the requirements of the study.
Exclusion criteria
1. A change in dose or introduction of another disease modifying anti-rheumatic drug, non-steroidal anti-inflammatory agent or oral steroid within the preceding month. 2. Intra-articular steroid injection within one month prior to enrolment 3. Evidence of serious uncontrolled chronic concomitant disease.
Outcome results
None listed