Methotrexate use is important for the treatment of Rheumatoid arthritis. Some patients can not tolerate oral methotrexate. So subcutaneous may help to overcome it.
Objective: To see the efficacy and safety of subcutaneous (SC) methotrexate (MTX) in patients suffering from active rheumatoid arthritis (RA). Methods: This was an open labeled randomized clinical trial. Total 90 patients were enrolled from out-patient and in-patients department of medicine (Rheumatology wing) Bangabandhu Sheikh Mujib Medical University. This study was done in two phases. In phase 1, after enrollment 10 mg MTX was given to all patients. After 4 weeks, the dose of MTX was increased by 5 mg. All patients were followed up at 8 weeks from enrollment for outcome measures and tolerability. In phase 2, patients who are intolerant to oral MTX will received 20 mg MTX subcutaneously (n=40). After 8 weeks the dose of MTX was increased by 5 mg. So, 25 mg MTX was given and after another 8 weeks final follow up was given both for clinical and laboratory outcome measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Tab. Methotrexate will be given orally in one arm at a dose of 25 mg/week
Inj. Methotrexate 25 mg/week will be given subcutaneously in another arm
American College of Rheumatology 20
20% reduction in disease activity
Time frame: "From enrollment to the end of treatment at 16 weeks"
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