A controlled double-blind trial was conducted to evaluate the efficacy of adalimumab in inducing and maintaining clincial remission in 494 patients with moderate-to-severe ulcerative colitis who received concurrent conventional therapy (oral corticosteriods or immunosuppressants). Primary end points were remission at weeks 8 and 52. Rates of clinical remission were significantly greater in the adalimumab treatment group at both time points when compared with the placebo-treated group. Adalimumab was safe, well-tolerated and effective in patients who did not have an adequate response to conventional therapy.