Rheumatoid arthritis (RA) is a chronic progressive inflammatory disease characterized by swelling and pain in multiple joints. The primary lesion of RA is considered to be in synovial membranes. Synovial cell proliferation gradually affects surrounding cartilage and bone, frequently leading to the disruption or deformation of joints. Physical symptoms other than those of joints include subcutaneous nodules or vascular inflammation, skin ulcers, and pulmonary fibrosis. RA is therefore considered not a joint disease but a systemic disease. Immune abnormalities underlie the pathology of RA, and the correction of these abnormalities is currently considered optimal therapy for RA. The outlook for patients with rheumatoid arthritis has improved significantly over the last three decades with the use of disease-modifying antirheumatic drugs. However, despite the use of methotrexate, cytokine inhibitors, and molecules targeting T and B cells, a percentage of patients do not respond or lose their response over time. Because of the known role of T cell activation in disease pathogenesis, the observed immunomodulating actions of tacrolimus, and the encouraging results of many clinical trials led us to develop Tacrolimus in RA. This is a Phase III, randomized, double blind, parallel study to compare the efficacy and safety of tacrolimus lipid tablets in adult patients with active rheumatoid arthritis (RA) resistance or intolerance to DMARDs. Patients will be permitted to remain on a stable dose of NSAIDs for at least 4 weeks prior to screening and a stable dose of oral glucocorticoid up to 10 mg (Prednisolone equivalent) for at least 4 weeks prior study drug administration and to be maintained throughout the study. The study will commence only after a written approval is obtained from the Independent/Institutional Ethics Committee and applicable regulatory authorities.