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

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
adalimumab
placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 47136
  • Site Reference ID/Investigator# 47159
  • Site Reference ID/Investigator# 47183
  • Site Reference ID/Investigator# 47135
  • Site Reference ID/Investigator# 47182
  • Site Reference ID/Investigator# 47124
  • Site Reference ID/Investigator# 47130
  • Site Reference ID/Investigator# 47103
  • Site Reference ID/Investigator# 47131
  • Site Reference ID/Investigator# 47178
  • Site Reference ID/Investigator# 47179
  • Site Reference ID/Investigator# 47176
  • Site Reference ID/Investigator# 47226
  • Site Reference ID/Investigator# 47123
  • Site Reference ID/Investigator# 47160
  • Site Reference ID/Investigator# 47108
  • Site Reference ID/Investigator# 47107
  • Site Reference ID/Investigator# 47181
  • Site Reference ID/Investigator# 47222
  • Site Reference ID/Investigator# 47223
  • Site Reference ID/Investigator# 47170
  • Site Reference ID/Investigator# 47171
  • Site Reference ID/Investigator# 47127
  • Site Reference ID/Investigator# 47172
  • Site Reference ID/Investigator# 47134
  • Site Reference ID/Investigator# 47225
  • Site Reference ID/Investigator# 47138
  • Site Reference ID/Investigator# 47168
  • Site Reference ID/Investigator# 47125
  • Site Reference ID/Investigator# 47126
  • Site Reference ID/Investigator# 47166
  • Site Reference ID/Investigator# 47122
  • Site Reference ID/Investigator# 47227
  • Site Reference ID/Investigator# 47174
  • Site Reference ID/Investigator# 47224
  • Site Reference ID/Investigator# 47177
  • Site Reference ID/Investigator# 47228
  • Site Reference ID/Investigator# 47128
  • Site Reference ID/Investigator# 47129
  • Site Reference ID/Investigator# 47169
  • Site Reference ID/Investigator# 47118
  • Site Reference ID/Investigator# 47158
  • Site Reference ID/Investigator# 47109
  • Site Reference ID/Investigator# 15853
  • Site Reference ID/Investigator# 47137
  • Site Reference ID/Investigator# 47104
  • Site Reference ID/Investigator# 47147
  • Site Reference ID/Investigator# 47180
  • Site Reference ID/Investigator# 47133
  • Site Reference ID/Investigator# 47173
  • Site Reference ID/Investigator# 47106
  • Site Reference ID/Investigator# 47132
  • Site Reference ID/Investigator# 47110
  • Site Reference ID/Investigator# 47111
  • Site Reference ID/Investigator# 47112
  • Site Reference ID/Investigator# 47116
  • Site Reference ID/Investigator# 47117
  • Site Reference ID/Investigator# 47161
  • Site Reference ID/Investigator# 47164
  • Site Reference ID/Investigator# 47165
  • Site Reference ID/Investigator# 47167
  • Site Reference ID/Investigator# 47105
  • Site Reference ID/Investigator# 47175
  • Site Reference ID/Investigator# 47121
  • Site Reference ID/Investigator# 47120

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Adalimumab 80 mg/40 mg

Adalimumab 160 mg/80 mg

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Percentage of Participants With Clinical Remission at 8, 32, and 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 scores 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.
Percentage of Participants With a Clinical Response
A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores: Stool Frequency Subscore, 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, based on the participant's diary and scored from zero (no blood) to three (blood only passed); Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration); Physician's Global Assessment 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.
Percentage of Participants With Mucosal Healing
Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52. The endoscopy subscore ranges from zero to three as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration).
Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)
Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed.
Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)
The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from zero to three as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3).
Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)
Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal.
Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders
An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
Number of Participants With Adverse Events up to Week 8
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.
Number of Participants With Adverse Events up to Week 52
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.
Number of Participants With Adverse Events During the Adalimumab Treatment Period
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.

Full Information

First Posted
February 27, 2009
Last Updated
September 3, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00853099
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Eisai Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Adalimumab 80 mg/40 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Adalimumab 160 mg/80 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7 Humira
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission at 8 Weeks
Description
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.
Time Frame
Week 8
Title
Percentage of Participants With Clinical Remission at 52 Weeks
Description
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.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks
Description
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 scores 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.
Time Frame
Weeks 8, 32, and 52
Title
Percentage of Participants With a Clinical Response
Description
A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores: Stool Frequency Subscore, 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, based on the participant's diary and scored from zero (no blood) to three (blood only passed); Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from zero (normal or inactive disease) to three (severe disease, spontaneous bleeding, ulceration); Physician's Global Assessment 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.
Time Frame
Baseline and Weeks 8, 32, and 52
Title
Percentage of Participants With Mucosal Healing
Description
Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52. The endoscopy subscore ranges from zero to three as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration).
Time Frame
Weeks 8, 32, and 52
Title
Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)
Description
Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed.
Time Frame
Weeks 8, 32, and 52
Title
Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)
Description
The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant's performance status. Possible scores range from zero to three as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3).
Time Frame
Weeks 8, 32, and 52
Title
Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)
Description
Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal.
Time Frame
Weeks 8, 32, and 52
Title
Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders
Description
An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (IBDQ) score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
Time Frame
Baseline and Weeks 8, 32, and 52
Title
Number of Participants With Adverse Events up to Week 8
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.
Time Frame
8 weeks
Title
Number of Participants With Adverse Events up to Week 52
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.
Time Frame
52 weeks
Title
Number of Participants With Adverse Events During the Adalimumab Treatment Period
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below.
Time Frame
221 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morio Ozawa, MS
Organizational Affiliation
AbbVie GK.
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 47136
City
Asahikawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 47159
City
Chiba
Country
Japan
Facility Name
Site Reference ID/Investigator# 47183
City
Chikushino
Country
Japan
Facility Name
Site Reference ID/Investigator# 47135
City
Fukuoka-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47182
City
Fukuoka-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47124
City
Hamamatsu
Country
Japan
Facility Name
Site Reference ID/Investigator# 47130
City
Hirakata-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47103
City
Hirosaki
Country
Japan
Facility Name
Site Reference ID/Investigator# 47131
City
Hiroshima-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47178
City
Hiroshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 47179
City
Hiroshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 47176
City
Izumo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47226
City
Kagoshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 47123
City
Kanazawa-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47160
City
Kashiwa
Country
Japan
Facility Name
Site Reference ID/Investigator# 47108
City
Kawagoe
Country
Japan
Facility Name
Site Reference ID/Investigator# 47107
City
Koshigaya
Country
Japan
Facility Name
Site Reference ID/Investigator# 47181
City
Kurume
Country
Japan
Facility Name
Site Reference ID/Investigator# 47222
City
Kurume
Country
Japan
Facility Name
Site Reference ID/Investigator# 47223
City
Kurume
Country
Japan
Facility Name
Site Reference ID/Investigator# 47170
City
Kyoto-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47171
City
Kyoto-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47127
City
Kyoto
Country
Japan
Facility Name
Site Reference ID/Investigator# 47172
City
Kyoto
Country
Japan
Facility Name
Site Reference ID/Investigator# 47134
City
Matsuyama-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47225
City
Miyazaki
Country
Japan
Facility Name
Site Reference ID/Investigator# 47138
City
Morioka-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47168
City
Nagakute-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47125
City
Nagoya-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47126
City
Nagoya-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47166
City
Nagoya-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47122
City
Niigata-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47227
City
Nishihara
Country
Japan
Facility Name
Site Reference ID/Investigator# 47174
City
Nishinomiya-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47224
City
Oita
Country
Japan
Facility Name
Site Reference ID/Investigator# 47177
City
Okayama-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47228
City
Okinawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 47128
City
Osaka-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47129
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 47169
City
Otsu-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47118
City
Sagamihara-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47158
City
Saitama-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47109
City
Sakura
Country
Japan
Facility Name
Site Reference ID/Investigator# 15853
City
Sapporo-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47137
City
Sapporo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47104
City
Sendai-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47147
City
Sendai-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47180
City
Susaki-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47133
City
Takamatsu
Country
Japan
Facility Name
Site Reference ID/Investigator# 47173
City
Takatsuki-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47106
City
Tokorozawa-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47132
City
Tokushima
Country
Japan
Facility Name
Site Reference ID/Investigator# 47110
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47111
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47112
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47116
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47117
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47161
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47164
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 47165
City
Toyama
Country
Japan
Facility Name
Site Reference ID/Investigator# 47167
City
Toyoake
Country
Japan
Facility Name
Site Reference ID/Investigator# 47105
City
Yamagata-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47175
City
Yamatotakada
Country
Japan
Facility Name
Site Reference ID/Investigator# 47121
City
Yokohama-shi
Country
Japan
Facility Name
Site Reference ID/Investigator# 47120
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.rxabbvie.com
Description
Related Info

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

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