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

NCT ID: NCT00853099

Last Updated: 2014-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-08-31

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 other week (eow) starting at Week 4 to Week 50, 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or placebo eow starting at Week 0 to Week 50 under the double-blind condition. At or after Week 8, participants who have inadequate response during the double-blind period can switch to the rescue arm, where participants from the placebo group initially receive adalimumab 160 mg and 80 mg 2 weeks later and those from the adalimumab group receive adalimumab 40 mg initially and 2 weeks later under double-blind conditions. All participants in the rescue arm then receive 40 mg adalimumab eow until Week 50. Participants who complete the 52-week double-blind period receive open-label adalimumab 40 mg eow starting at Week 52 and continuing until the end of the study. Participants who have an inadequate response or disease flare can dose escalate to 80 mg eow at or after Week 60. Participants who dose escalate to 80 mg eow and continue to have an inadequate response or disease flare are withdrawn from the study.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.

Group Type: PLACEBO_COMPARATOR

adalimumab

Intervention Type: BIOLOGICAL

placebo

Intervention Type: DRUG

Adalimumab 80 mg/40 mg

Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab 160 mg/80 mg

Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Interventions

adalimumab

Intervention Type: BIOLOGICAL

placebo

Intervention Type: DRUG

Other Intervention Names

ABT-D2E7 Humira

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morio Ozawa, MS

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 15853

Sapporo, , Japan

Site Reference ID/Investigator# 47137

Sapporo, , Japan

Site Reference ID/Investigator# 47104

Sendai, , Japan

Site Reference ID/Investigator# 47147

Sendai, , Japan

Site Reference ID/Investigator# 47180

Susaki-shi, , Japan

Site Reference ID/Investigator# 47133

Takamatsu, , Japan

Site Reference ID/Investigator# 47173

Takatsuki-shi, , Japan

Site Reference ID/Investigator# 47106

Tokorozawa-shi, , Japan

Site Reference ID/Investigator# 47132

Tokushima, , Japan

Site Reference ID/Investigator# 47110

Tokyo, , Japan

Site Reference ID/Investigator# 47111

Tokyo, , Japan

Site Reference ID/Investigator# 47112

Tokyo, , Japan

Site Reference ID/Investigator# 47116

Tokyo, , Japan

Site Reference ID/Investigator# 47117

Tokyo, , Japan

Site Reference ID/Investigator# 47161

Tokyo, , Japan

Site Reference ID/Investigator# 47164

Tokyo, , Japan

Site Reference ID/Investigator# 47165

Toyama, , Japan

Site Reference ID/Investigator# 47167

Toyoake, , Japan

Site Reference ID/Investigator# 47105

Yamagata, , Japan

Site Reference ID/Investigator# 47175

Yamatotakada, , Japan

Site Reference ID/Investigator# 47120

Yokohama, , Japan

Site Reference ID/Investigator# 47121

Yokohama, , Japan

Site Reference ID/Investigator# 47136

Asahikawa, , Japan

Site Reference ID/Investigator# 47159

Chiba, , Japan

Site Reference ID/Investigator# 47183

Chikushino-shi, , Japan

Site Reference ID/Investigator# 47135

Fukuoka, , Japan

Site Reference ID/Investigator# 47182

Fukuoka, , Japan

Site Reference ID/Investigator# 47124

Hamamatsu, , Japan

Site Reference ID/Investigator# 47130

Hirakata-shi, , Japan

Site Reference ID/Investigator# 47103

Hirosaki, , Japan

Site Reference ID/Investigator# 47131

Hiroshima, , Japan

Site Reference ID/Investigator# 47178

Hiroshima, , Japan

Site Reference ID/Investigator# 47179

Hiroshima, , Japan

Site Reference ID/Investigator# 47176

Izumo, , Japan

Site Reference ID/Investigator# 47226

Kagoshima, , Japan

Site Reference ID/Investigator# 47123

Kanazawa, , Japan

Site Reference ID/Investigator# 47160

Kashiwa, , Japan

Site Reference ID/Investigator# 47108

Kawagoe, , Japan

Site Reference ID/Investigator# 47107

Koshigaya, , Japan

Site Reference ID/Investigator# 47181

Kurume, , Japan

Site Reference ID/Investigator# 47222

Kurume, , Japan

Site Reference ID/Investigator# 47223

Kurume, , Japan

Site Reference ID/Investigator# 47127

Kyoto, , Japan

Site Reference ID/Investigator# 47170

Kyoto, , Japan

Site Reference ID/Investigator# 47171

Kyoto, , Japan

Site Reference ID/Investigator# 47172

Kyoto, , Japan

Site Reference ID/Investigator# 47134

Matsuyama, , Japan

Site Reference ID/Investigator# 47225

Miyazaki, , Japan

Site Reference ID/Investigator# 47138

Morioka, , Japan

Site Reference ID/Investigator# 47168

Nagakute-shi, , Japan

Site Reference ID/Investigator# 47125

Nagoya, , Japan

Site Reference ID/Investigator# 47126

Nagoya, , Japan

Site Reference ID/Investigator# 47166

Nagoya, , Japan

Site Reference ID/Investigator# 47122

Niigata, , Japan

Site Reference ID/Investigator# 47227

Nishihara, , Japan

Site Reference ID/Investigator# 47174

Nishinomiya-shi, , Japan

Site Reference ID/Investigator# 47177

Okayama, , Japan

Site Reference ID/Investigator# 47228

Okinawa, , Japan

Site Reference ID/Investigator# 47128

Osaka, , Japan

Site Reference ID/Investigator# 47129

Osaka, , Japan

Site Reference ID/Investigator# 47224

Ōita, , Japan

Site Reference ID/Investigator# 47169

Ōtsu, , Japan

Site Reference ID/Investigator# 47118

Sagamihara-shi, , Japan

Site Reference ID/Investigator# 47158

Saitama-shi, , Japan

Site Reference ID/Investigator# 47109

Sakura, , Japan

Countries

Japan

Related Links

http://www.rxabbvie.com

Related Info

Other Identifiers

M10-447

Identifier Type: -

Identifier Source: org_study_id