Status:
COMPLETED
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief 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).
Detailed Description
Patients who meet all of the inclusion criteria and none of the exclusion criteria are randomized 1:1:1 to receive subcutaneous injections of adalimumab at either 160/80 mg at Week 0/2 and 40 mg every...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00853099
Start Date
February 1 2009
End Date
August 1 2013
Last Update
September 5 2014
Active Locations (65)
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1
Site Reference ID/Investigator# 47136
Asahikawa, Japan
2
Site Reference ID/Investigator# 47159
Chiba, Japan
3
Site Reference ID/Investigator# 47183
Chikushino-shi, Japan
4
Site Reference ID/Investigator# 47135
Fukuoka, Japan