A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Collaborator: Eisai Co., Ltd.
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.