Clinical trial NCT00853099: A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Eisai Co., Ltd.
First posted: 2009-03-02
Enrollment: 274
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Participants who dose escalate to 80 mg eow and continue to have an inadequate response or disease flare are withdrawn from the study.

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.

Primary outcomes:
measure: Percentage of Participants With Clinical Remission at 8 Weeks
timeFrame: Week 8
measure: Percentage of Participants With Clinical Remission at 52 Weeks
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks
timeFrame: Weeks 8, 32, and 52
measure: Percentage of Participants With a Clinical Response
timeFrame: Baseline and Weeks 8, 32, and 52
measure: Percentage of Participants With Mucosal Healing
timeFrame: Weeks 8, 32, and 52
measure: Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)
timeFrame: Weeks 8, 32, and 52
measure: Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)
timeFrame: Weeks 8, 32, and 52
measure: Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)
timeFrame: Weeks 8, 32, and 52
measure: Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders
timeFrame: Baseline and Weeks 8, 32, and 52
measure: Number of Participants With Adverse Events up to Week 8
timeFrame: 8 weeks
measure: Number of Participants With Adverse Events up to Week 52
timeFrame: 52 weeks
measure: Number of Participants With Adverse Events During the Adalimumab Treatment Period
timeFrame: 221 weeks
Other outcomes:
Locations:
city: Asahikawa
country: Japan
facility: Site Reference ID/Investigator# 47136
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 47159
city: Chikushino
country: Japan
facility: Site Reference ID/Investigator# 47183
city: Fukuoka-shi
country: Japan
facility: Site Reference ID/Investigator# 47135
city: Fukuoka-shi
country: Japan
facility: Site Reference ID/Investigator# 47182
city: Hamamatsu
country: Japan
facility: Site Reference ID/Investigator# 47124
city: Hirakata-shi
country: Japan
facility: Site Reference ID/Investigator# 47130
city: Hirosaki
country: Japan
facility: Site Reference ID/Investigator# 47103
city: Hiroshima-shi
country: Japan
facility: Site Reference ID/Investigator# 47131
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 47178
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 47179
city: Izumo
country: Japan
facility: Site Reference ID/Investigator# 47176
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 47226
city: Kanazawa-shi
country: Japan
facility: Site Reference ID/Investigator# 47123
city: Kashiwa
country: Japan
facility: Site Reference ID/Investigator# 47160
city: Kawagoe
country: Japan
facility: Site Reference ID/Investigator# 47108
city: Koshigaya
country: Japan
facility: Site Reference ID/Investigator# 47107
city: Kurume
country: Japan
facility: Site Reference ID/Investigator# 47181
city: Kurume
country: Japan
facility: Site Reference ID/Investigator# 47222
city: Kurume
country: Japan
facility: Site Reference ID/Investigator# 47223
city: Kyoto-shi
country: Japan
facility: Site Reference ID/Investigator# 47170
city: Kyoto-shi
country: Japan
facility: Site Reference ID/Investigator# 47171
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 47127
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 47172
city: Matsuyama-shi
country: Japan
facility: Site Reference ID/Investigator# 47134
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 47225
city: Morioka-shi
country: Japan
facility: Site Reference ID/Investigator# 47138
city: Nagakute-shi
country: Japan
facility: Site Reference ID/Investigator# 47168
city: Nagoya-shi
country: Japan
facility: Site Reference ID/Investigator# 47125
city: Nagoya-shi
country: Japan
facility: Site Reference ID/Investigator# 47126
city: Nagoya-shi
country: Japan
facility: Site Reference ID/Investigator# 47166
city: Niigata-shi
country: Japan
facility: Site Reference ID/Investigator# 47122
city: Nishihara
country: Japan
facility: Site Reference ID/Investigator# 47227
city: Nishinomiya-shi
country: Japan
facility: Site Reference ID/Investigator# 47174
city: Oita
country: Japan
facility: Site Reference ID/Investigator# 47224
city: Okayama-shi
country: Japan
facility: Site Reference ID/Investigator# 47177
city: Okinawa
country: Japan
facility: Site Reference ID/Investigator# 47228
city: Osaka-shi
country: Japan
facility: Site Reference ID/Investigator# 47128
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 47129
city: Otsu-shi
country: Japan
facility: Site Reference ID/Investigator# 47169
city: Sagamihara-shi
country: Japan
facility: Site Reference ID/Investigator# 47118
city: Saitama-shi
country: Japan
facility: Site Reference ID/Investigator# 47158
city: Sakura
country: Japan
facility: Site Reference ID/Investigator# 47109
city: Sapporo-shi
country: Japan
facility: Site Reference ID/Investigator# 15853
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 47137
city: Sendai-shi
country: Japan
facility: Site Reference ID/Investigator# 47104
city: Sendai-shi
country: Japan
facility: Site Reference ID/Investigator# 47147
city: Susaki-shi
country: Japan
facility: Site Reference ID/Investigator# 47180
city: Takamatsu
country: Japan
facility: Site Reference ID/Investigator# 47133
city: Takatsuki-shi
country: Japan
facility: Site Reference ID/Investigator# 47173
city: Tokorozawa-shi
country: Japan
facility: Site Reference ID/Investigator# 47106
city: Tokushima
country: Japan
facility: Site Reference ID/Investigator# 47132
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47110
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47111
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47112
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47116
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47117
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47161
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 47164
city: Toyama
country: Japan
facility: Site Reference ID/Investigator# 47165
city: Toyoake
country: Japan
facility: Site Reference ID/Investigator# 47167
city: Yamagata-shi
country: Japan
facility: Site Reference ID/Investigator# 47105
city: Yamatotakada
country: Japan
facility: Site Reference ID/Investigator# 47175
city: Yokohama-shi
country: Japan
facility: Site Reference ID/Investigator# 47121
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 47120
Study officials:
affiliation: AbbVie
name: Morio Ozawa, MS
role: STUDY_DIRECTOR
References: