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

• Conditions: lcerative Colitis; MedDRA version: 17.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-004559-29-Outside-EU/EEA
• Lead Sponsor: AbbVie Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-12
• Last Update Posted: 17 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 274

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.

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified