None listed
Conditions
Brief summary
Loading doses of methotrexate (where high dose methotrexate injection is given once weekly for three weeks at the start to control the disease activity of rheumatoid arthritis, followed by lower dose of oral methotrexate as maintenance) have been used sporadically by rheumatologists in practice, but the research evidence for the loading dose of methotrexate is limited. This study is aimed to investigate how the concentration of methotrexate and its active metabolites differ compared to the standard dose regimen. Also, this study is also aimed to assess the feasibility to implement this loading dose regimen in real life, and the patient's attitude towards this new dosing regimen.
Interventions
All participants will receive triple disease-modifying antirheumatic drugs (DMARDs) therapy with the drugs that are standard-of-care at the Royal Adelaide Hospital (RAH) (hydroxychloroquine, sulfasalazine, methotrexate) – the decision to initiate this therapy is not a part of this study. The intervention arm will receive a higher initial dose of methotrexate (50 mg once weekly subcutaneously) + oral sulfasalazine + oral hydroxychloroquine for the first 3 weeks, followed by standard dosing of met
All participants will receive triple disease-modifying antirheumatic drugs (DMARDs) therapy with the drugs that are standard-of-care at the Royal Adelaide Hospital (RAH) (hydroxychloroquine, sulfasalazine, methotrexate) – the decision to initiate this therapy is not a part of this study. The intervention arm will receive a higher initial dose of methotrexate (50 mg once weekly subcutaneously) + oral sulfasalazine + oral hydroxychloroquine for the first 3 weeks, followed by standard dosing of methotrexate (20mg once weekly orally) + oral sulfasalazine + oral hydroxychloroquine for the next 3 weeks. The patient's adherence will be monitored through laboratory tests, patient's medical record and patient's self-reported adherence.
Sponsors
Central Adelaide Local Health Network Incorporated
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients attending the rheumatology clinic at the Central Adelaide Local Health Network (CALHN) who have active rheumatoid arthritis and for whom the decision has been made to commence methotrexate (and sulfasalazine and hydroxychloroquine) as triple DMARD therapy. The decision to use methotrexate is not part of this trial. It will be made according to clinical need and according to our standardised inclusion criteria for commencement of methotrexate therapy. These include: 1) ALT < 2x ULN 2) Calculated Creatinine Clearance > 60 mL/min (Cockcroft-Gault) 3) Neutrophils within normal range 4) If a smoker, Pulmonary Function Tests will be conducted, and they must have FVC>70% predicted and DLCO> 60% predicted 5) At least 5 years since treatment for a malignancy (except non-melanoma skin cancers) 6) Not pregnant (test is done as standard prior to MTX commencement) 7) Able to read English and/or good communication skills. 8) Age greater than or equal to 18 years
Exclusion criteria
1) BMI < 18 because sub-cutaneous injections of MTX will be used in the loading dose group. An upper BMI was discussed but there is no apparent reason for specifying an upper limit. 2) Age > 85 years
Outcome results
None listed