About ULTRA 1ULTRA 1 was an eight week, multi-center, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of HUMIRA for the induction of clinical remission per Mayo score in 390 anti-TNF naive adult patients who had moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (i.e., corticosteroids, azathioprine, or 6-mercaptopurine).Mayo score is a measure of disease activity that ranges from 0 to 12 and includes stool frequency, rectal bleeding, endoscopic findings and physician's global assessment. Patients were randomized to treatment with HUMIRA 160/80 mg (160 mg, week zero; 80 mg, week two; 40 mg, weeks four and six), HUMIRA 80/40 mg (80 mg, week zero; 40 mg; weeks two, four and six) or placebo. Patients, including those randomized to placebo, continued conventional therapy such as corticosteroids, aminosalicylates and immunosuppressants. The primary efficacy endpoint was clinical remission (defined as a Mayo score of two or less, with no individual subscore greater than one) at week eight.
Abbott Announces Three-Year Long-Term Data Evaluating Efficacy With HUMIRA® (Adalimumab) For Patients With Moderately To Severely Active Ulcerative Colitis
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