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

NCT00853099 | Completed Phase 3 Results

• 1 other identifier: M10-447
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 65

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).

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Clinical Remission at 8 Weeks

  Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore \> 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores: * Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal); * Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed); * Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease). The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

  Week 8

• Percentage of Participants With Clinical Remission at 52 Weeks

  Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore \> 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores: * Stool Frequency Subscore (SFS), based on the participant's diary and scored from zero (normal number of stools) to three (5 or more stools than normal); * Rectal Bleeding Subscore (RBS), based on the participant's diary and scored from zero (no blood) to three (blood only passed); * Endoscopy Subscore (ESS), based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration); * Physician's Global Assessment (PGA) subscore, based on the physician's overall assessment, and scored from zero (normal) to three (severe disease). The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease.

  Week 52

Secondary Outcomes (10)

• Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks

  Weeks 8, 32, and 52

• Percentage of Participants With a Clinical Response

  Baseline and Weeks 8, 32, and 52

• Percentage of Participants With Mucosal Healing

  Weeks 8, 32, and 52

• Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)

  Weeks 8, 32, and 52

• Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)

  Weeks 8, 32, and 52

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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.

Biological: adalimumab; Drug: placebo

Adalimumab 80 mg/40 mg

EXPERIMENTAL

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.

Biological: adalimumab

Adalimumab 160 mg/80 mg

EXPERIMENTAL

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.

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

Also known as: ABT-D2E7 Humira

Adalimumab 160 mg/80 mg; Adalimumab 80 mg/40 mg; Placebo

placebo DRUG

Placebo

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Eisai Co., Ltd.: collaborator

Study Sites (65)

Site Reference ID/Investigator# 47136

Asahikawa, Japan

Location

Site Reference ID/Investigator# 47159

Chiba, Japan

Location

Site Reference ID/Investigator# 47183

Chikushino-shi, Japan

Location

Site Reference ID/Investigator# 47135

Fukuoka, Japan

Location

Site Reference ID/Investigator# 47182

Fukuoka, Japan

Location

Site Reference ID/Investigator# 47124

Hamamatsu, Japan

Location

Site Reference ID/Investigator# 47130

Hirakata-shi, Japan

Location

Site Reference ID/Investigator# 47103

Hirosaki, Japan

Location

Site Reference ID/Investigator# 47131

Hiroshima, Japan

Location

Site Reference ID/Investigator# 47178

Hiroshima, Japan

Location

Site Reference ID/Investigator# 47179

Hiroshima, Japan

Location

Site Reference ID/Investigator# 47176

Izumo, Japan

Location

Site Reference ID/Investigator# 47226

Kagoshima, Japan

Location

Site Reference ID/Investigator# 47123

Kanazawa, Japan

Location

Site Reference ID/Investigator# 47160

Kashiwa, Japan

Location

Site Reference ID/Investigator# 47108

Kawagoe, Japan

Location

Site Reference ID/Investigator# 47107

Koshigaya, Japan

Location

Site Reference ID/Investigator# 47181

Kurume, Japan

Location

Site Reference ID/Investigator# 47222

Kurume, Japan

Location

Site Reference ID/Investigator# 47223

Kurume, Japan

Location

Site Reference ID/Investigator# 47127

Kyoto, Japan

Location

Site Reference ID/Investigator# 47170

Kyoto, Japan

Location

Site Reference ID/Investigator# 47171

Kyoto, Japan

Location

Site Reference ID/Investigator# 47172

Kyoto, Japan

Location

Site Reference ID/Investigator# 47134

Matsuyama, Japan

Location

Site Reference ID/Investigator# 47225

Miyazaki, Japan

Location

Site Reference ID/Investigator# 47138

Morioka, Japan

Location

Site Reference ID/Investigator# 47168

Nagakute-shi, Japan

Location

Site Reference ID/Investigator# 47125

Nagoya, Japan

Location

Site Reference ID/Investigator# 47126

Nagoya, Japan

Location

Site Reference ID/Investigator# 47166

Nagoya, Japan

Location

Site Reference ID/Investigator# 47122

Niigata, Japan

Location

Site Reference ID/Investigator# 47227

Nishihara, Japan

Location

Site Reference ID/Investigator# 47174

Nishinomiya-shi, Japan

Location

Site Reference ID/Investigator# 47177

Okayama, Japan

Location

Site Reference ID/Investigator# 47228

Okinawa, Japan

Location

Site Reference ID/Investigator# 47128

Osaka, Japan

Location

Site Reference ID/Investigator# 47129

Osaka, Japan

Location

Site Reference ID/Investigator# 47224

Ōita, Japan

Location

Site Reference ID/Investigator# 47169

Ōtsu, Japan

Location

Site Reference ID/Investigator# 47118

Sagamihara-shi, Japan

Location

Site Reference ID/Investigator# 47158

Saitama-shi, Japan

Location

Site Reference ID/Investigator# 47109

Sakura, Japan

Location

Site Reference ID/Investigator# 15853

Sapporo, Japan

Location

Site Reference ID/Investigator# 47137

Sapporo, Japan

Location

Site Reference ID/Investigator# 47104

Sendai, Japan

Location

Site Reference ID/Investigator# 47147

Sendai, Japan

Location

Site Reference ID/Investigator# 47180

Susaki-shi, Japan

Location

Site Reference ID/Investigator# 47133

Takamatsu, Japan

Location

Site Reference ID/Investigator# 47173

Takatsuki-shi, Japan

Location

Site Reference ID/Investigator# 47106

Tokorozawa-shi, Japan

Location

Site Reference ID/Investigator# 47132

Tokushima, Japan

Location

Site Reference ID/Investigator# 47110

Tokyo, Japan

Location

Site Reference ID/Investigator# 47111

Tokyo, Japan

Location

Site Reference ID/Investigator# 47112

Tokyo, Japan

Location

Site Reference ID/Investigator# 47116

Tokyo, Japan

Location

Site Reference ID/Investigator# 47117

Tokyo, Japan

Location

Site Reference ID/Investigator# 47161

Tokyo, Japan

Location

Site Reference ID/Investigator# 47164

Tokyo, Japan

Location

Site Reference ID/Investigator# 47165

Toyama, Japan

Location

Site Reference ID/Investigator# 47167

Toyoake, Japan

Location

Site Reference ID/Investigator# 47105

Yamagata, Japan

Location

Site Reference ID/Investigator# 47175

Yamatotakada, Japan

Location

Site Reference ID/Investigator# 47120

Yokohama, Japan

Location

Site Reference ID/Investigator# 47121

Yokohama, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Morio Ozawa, MS

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2013
• Last Updated: September 5, 2014
• Results First Posted: November 27, 2012

Record last verified: 2014-09

Locations

JP (65)