Ulcerative ColitisPhase 3NCT00853099
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing adalimumab in people with Ulcerative Colitis, run by AbbVie (prior sponsor, Abbott) at 65 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 65 sitesJapan
- Study dates
- Feb 2009to Aug 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
Japan65 sites
Site Reference ID/Investigator# 47136
Asahikawa
Site Reference ID/Investigator# 47159
Chiba
Site Reference ID/Investigator# 47183
Chikushino-shi
Site Reference ID/Investigator# 47135
Fukuoka
Site Reference ID/Investigator# 47182
Fukuoka
Site Reference ID/Investigator# 47124
Hamamatsu
Site Reference ID/Investigator# 47130
Hirakata-shi
Site Reference ID/Investigator# 47103
Hirosaki
Site Reference ID/Investigator# 47131
Hiroshima
Site Reference ID/Investigator# 47178
Hiroshima
Site Reference ID/Investigator# 47179
Hiroshima
Site Reference ID/Investigator# 47176
Izumo
Site Reference ID/Investigator# 47226
Kagoshima
Site Reference ID/Investigator# 47123
Kanazawa
Site Reference ID/Investigator# 47160
Kashiwa
Site Reference ID/Investigator# 47108
Kawagoe
Site Reference ID/Investigator# 47107
Koshigaya
Site Reference ID/Investigator# 47181
Kurume
Site Reference ID/Investigator# 47222
Kurume
Site Reference ID/Investigator# 47223
Kurume
Site Reference ID/Investigator# 47127
Kyoto
Site Reference ID/Investigator# 47170
Kyoto
Site Reference ID/Investigator# 47171
Kyoto
Site Reference ID/Investigator# 47172
Kyoto
Site Reference ID/Investigator# 47134
Matsuyama
Site Reference ID/Investigator# 47225
Miyazaki
Site Reference ID/Investigator# 47138
Morioka
Site Reference ID/Investigator# 47168
Nagakute-shi
Site Reference ID/Investigator# 47125
Nagoya
Site Reference ID/Investigator# 47126
Nagoya
Site Reference ID/Investigator# 47166
Nagoya
Site Reference ID/Investigator# 47122
Niigata
Site Reference ID/Investigator# 47227
Nishihara
Site Reference ID/Investigator# 47174
Nishinomiya-shi
Site Reference ID/Investigator# 47224
Ōita
Site Reference ID/Investigator# 47177
Okayama
Site Reference ID/Investigator# 47228
Okinawa
Site Reference ID/Investigator# 47128
Osaka
Site Reference ID/Investigator# 47129
Osaka
Site Reference ID/Investigator# 47169
Ōtsu
Site Reference ID/Investigator# 47118
Sagamihara-shi
Site Reference ID/Investigator# 47158
Saitama-shi
Site Reference ID/Investigator# 47109
Sakura
Site Reference ID/Investigator# 15853
Sapporo
Site Reference ID/Investigator# 47137
Sapporo
Site Reference ID/Investigator# 47104
Sendai
Site Reference ID/Investigator# 47147
Sendai
Site Reference ID/Investigator# 47180
Susaki-shi
Site Reference ID/Investigator# 47133
Takamatsu
Site Reference ID/Investigator# 47173
Takatsuki-shi
Site Reference ID/Investigator# 47106
Tokorozawa-shi
Site Reference ID/Investigator# 47132
Tokushima
Site Reference ID/Investigator# 47110
Tokyo
Site Reference ID/Investigator# 47111
Tokyo
Site Reference ID/Investigator# 47112
Tokyo
Site Reference ID/Investigator# 47116
Tokyo
Site Reference ID/Investigator# 47117
Tokyo
Site Reference ID/Investigator# 47161
Tokyo
Site Reference ID/Investigator# 47164
Tokyo
Site Reference ID/Investigator# 47165
Toyama
Site Reference ID/Investigator# 47167
Toyoake
Site Reference ID/Investigator# 47105
Yamagata
Site Reference ID/Investigator# 47175
Yamatotakada
Site Reference ID/Investigator# 47120
Yokohama
Site Reference ID/Investigator# 47121
Yokohama
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis.
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).
Read the 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
- Being tested
- adalimumab, placebo
- Keywords
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabBiological
Also called ABT-D2E7 Humira
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 52
Secondary outcomes (10)
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.
Measured: Weeks 8, 32, and 52
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.
Measured: Baseline and Weeks 8, 32, and 52
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).
Measured: Weeks 8, 32, and 52
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.
Measured: Weeks 8, 32, and 52
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).
Measured: Weeks 8, 32, and 52
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.
Measured: Weeks 8, 32, and 52
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).
Measured: Baseline and Weeks 8, 32, and 52
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.
Measured: 8 weeks
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.
Measured: 52 weeks
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.
Measured: 221 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Morio Ozawa, MS, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853099
- Sponsor's protocol ID
- M10-447
- Status last verified
- Sep 2014
- First submitted
- 27 Feb 2009
- Last updated
- 5 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT00853099
- Acronym / sponsor ID
- M10-447
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Eisai Co., Ltd.
- Study start
- Feb 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 27 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: adalimumab, Drug: placeboParticipants 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. |
| Adalimumab 80 mg/40 mg | Experimental | Biological: adalimumabParticipants 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. |
| Adalimumab 160 mg/80 mg | Experimental | Biological: adalimumabParticipants 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: ABT-D2E7 Humira | Biological | Adalimumab 160 mg/80 mg, Adalimumab 80 mg/40 mg, Placebo |
| placebo | Drug | Placebo |
Primary outcome
Percentage of Participants With Clinical Remission at 8 Weeks
Time frame: Week 8
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
Time frame: Week 52
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.
10 secondary outcomes
Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks
Time frame: Weeks 8, 32, and 52
Percentage of Participants With a Clinical Response
Time frame: Baseline and Weeks 8, 32, and 52
Percentage of Participants With Mucosal Healing
Time frame: Weeks 8, 32, and 52
Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1)
Time frame: Weeks 8, 32, and 52
Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1)
Time frame: Weeks 8, 32, and 52
Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1)
Time frame: Weeks 8, 32, and 52
Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders
Time frame: Baseline and Weeks 8, 32, and 52
Number of Participants With Adverse Events up to Week 8
Time frame: 8 weeks
Number of Participants With Adverse Events up to Week 52
Time frame: 52 weeks
Number of Participants With Adverse Events During the Adalimumab Treatment Period
Time frame: 221 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morio Ozawa, MS study director
AbbVie
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab in people with Ulcerative Colitis, run by AbbVie (prior sponsor, Abbott) at 65 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinical Remission at 8 Weeks (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.