A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis

AbbVie Inc.0 个研究点目标入组 274 人开始时间: 2014年11月12日最近更新: 2014年11月17日

试验速览

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•Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
•Active ulcerative colitis with a Mayo Score of 6-12 points at Baseline and endoscopy subscore of 2-3 during the Screening Period, despite concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):
•Stable oral corticosteroid dose (prednisolone dose of = 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisolone of 5 to less than 20 mg/day) for at least 40 days prior to Baseline. And/or
•At least a consecutive 90-day course of azathioprine or 6-mercaptopurine (6-MP) prior to Baseline, with a dose of azathioprine = 50 mg/day or 6-MP = 30 mg/day, or a dose that was the highest tolerated by the patient.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 274
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis or was planning bowel surgery.
•Patients with disease limited to the rectum.
•Indeterminate colitis and/or Crohn's disease.
•Received any biological therapy (including infliximab) in the past.
•History of tuberculosis or malignancy.
•Pregnant women.
•Patients with positive C. difficile stool assay at Screening.
•Current diagnosis of fulminant colitis and/or toxic megacolon.

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