OP0015 Induction of remission and maintenance in early, aggressive rheumatoid arthritis using adalimumab in combination with methotrexate with or without short-term high-dose glucocorticoids: results of a phase iv multicenter, randomized, double blind study (clintrial.gov: NCT00480272)
Background Remission is the current aim of early RA treatment. In patients with early, aggressive RA, combination with adalimumab (ADA) plus methotrexate (MTX) was superior to either MTX or ADA alone in obtaining clinical remission. Moreover, it has been demonstrated that a short-term aggressive treatment with high-dose glucocorticoids (GC) plus conventional DMARDs lead to long-term (up to 5 years) benefits. Objectives To compare the proportion of patients who achieve remission at 12 months, between two groups of subjects treated with ADA + MTX + high dose GC (intensive) and ADA + MTX + placebo (standard), and to evaluate the proportion of those maintaining remission at 24 months, after dis…