Aim of the study: The aim of this study was to compare the effects of subcutaneously administered MTX with that of orally administered one and to compare changes in clinical and laboratory measures of activity of rheumatoid arthritis.

Methods and Materials: This was a randomized clinical trial to compare the efficacy and safety of SC injectable MTX in active rheumatoid arthritis patients with that of oral one. This study was conducted during the period of January 2005 to February 2007. A total of 168 patients of RA were included in this study. Fourteen patients dropped out during this study period. They failed to attend follow up after enrolment or developed toxicities. So, finally 154 patients completed the trial. The patient with RA attending rheumatology OPD in BSMMU were considered for inclusion in the study (According to American Rheumatism Association 1988 revision criteria).

Results: In analyzing the ACR response we found, ACR-20 response was achieved by 62.3% of patients in injectable group and 39.2% in oral group where P<0.01, ACR-50 response was achieved by 38.7% in injectable group and 20.3% in oral group where P<0.05 and ACR 70 response was achieved by 8% in injectable group and 2.5% in oral group where p value was >0.10 which was not statistically significant.

Conclusion: From the present study, it may be concluded that MTX is effective in controlling disease activity in rheumatoid arthritis. Subcutaneously administered MTX is more effective than that of oral form. Future trials including bigger samples and more vigorous study design will probably determine the disease controlling ability of subcutaneous MTX before considering biological agent, which are too costly.