Trials With Remicade Show Clinical Benefit in Treating Ulcerative Colitis

Results from two Phase III, placebo-controlled clinical trials found that approximately two-thirds of patients with moderate-to-severe, active ulcerative colitis (UC) treated with Remicade demonstrated a significant improvement in symptoms.

In addition, one-third of patients achieved clinical remission. Data from the ACT I and ACT II clinical trials show Remicade (infliximab, 5 mg/kg) achieved all primary and secondary endpoints of clinical response accompanied by decreases in rectal bleeding, and improvement in mucosal healing. Patients also were able to meaningfully reduce or eliminate steroid medications.

ACT I and ACT II are multicenter, Phase III, randomized, double-blind, placebo-controlled, clinical trials conducted to evaluate the safety and efficacy of Remicade for the treatment of active UC. There were 364 patients enrolled in ACT I and ACT II with active moderate or severe UC who were unresponsive to at least one standard therapy. For both trials, patients were randomized to receive placebo or Remicade 5 mg/kg or 10 mg/kg. Patients in ACT I were evaluated through Week 46 and ACT II patients were evaluated through Week 22.