Sikkerhed og effekt ved Remicade blev vurderet i to (ACT 1 og ACT 2) randomiserede, dobbeltblinde, placebokontrollerede kliniske undersøgelser hos voksne patienter med moderat til svær, aktiv colitis ulcerosa (Mayo score 6 til 12; Endoskopi subscore 2) med et utilstrækkeligt respons på konventionel behandling [orale kortikosteroider, aminosalicylater og/ eller immunmodulatorer (6- MP, AZA)].
The safety and efficacy of Remicade were assessed in two (ACT 1 and ACT 2) randomized, double- blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/ or immunomodulators (6-MP, AZA)].