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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00573794
Registration number
NCT00573794
Ethics application status
Date submitted
12/12/2007
Date registered
14/12/2007
Date last updated
7/07/2021
Titles & IDs
Public title
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
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Scientific title
A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
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Secondary ID [1]
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2007-004157-28
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Secondary ID [2]
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M10-223
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - adalimumab
Experimental: Adalimumab 40 mg EOW/EW - Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Treatment: Other: adalimumab
adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Partial Mayo Score: Change From Baseline Over Time
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Assessment method [1]
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The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.
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Timepoint [1]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Primary outcome [2]
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Mayo Score: Change From Baseline Over Time
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Assessment method [2]
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The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
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Timepoint [2]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [1]
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Percentage of Participants With Remission Per Partial Mayo Score Over Time
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Assessment method [1]
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The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). Remission was defined as Partial Mayo score = 2 with no subscore \> 1.
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Timepoint [1]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [2]
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Mayo Endoscopy Subscore: Change From Baseline Over Time
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Assessment method [2]
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The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement.
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Timepoint [2]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [3]
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Mayo Rectal Bleeding Subscore: Change From Baseline Over Time
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Assessment method [3]
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The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement.
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Timepoint [3]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [4]
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Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time
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Assessment method [4]
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The Mayo Physician's Global Assessment of Disease Severity subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Physician's Global Assessment of Disease Severity subscore indicates improvement.
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Timepoint [4]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [5]
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Mayo Stool Frequency Subscore: Change From Baseline Over Time
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Assessment method [5]
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The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement.
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Timepoint [5]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [6]
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Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time
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Assessment method [6]
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The IBDQ is a 32-item questionnaire that assesses how the subject felt during the 2 weeks before the measurement time point. Questions are related to symptoms the subject might have had as a result of UC, how the subject felt in general, how the subject's mood was, and social and work problems the subject might have that resulted from UC. An increase in IBDQ score indicates less impact of UC on the subject's life. The responses to each question 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).
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Timepoint [6]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [7]
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36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time
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Assessment method [7]
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The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
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Timepoint [7]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [8]
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36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time
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Assessment method [8]
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The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.
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Timepoint [8]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [9]
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Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time
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Assessment method [9]
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The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.
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Timepoint [9]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [10]
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WPAI:GH Impairment While Working: Change From Baseline Over Time
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Assessment method [10]
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The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.
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Timepoint [10]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [11]
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WPAI:GH Overall Work Impairment: Change From Baseline Over Time
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Assessment method [11]
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The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.
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Timepoint [11]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [12]
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WPAI:GH Activity Impairment: Change From Baseline Over Time
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Assessment method [12]
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The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.
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Timepoint [12]
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Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
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Secondary outcome [13]
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Colectomy Rate
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Assessment method [13]
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The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.
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Timepoint [13]
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5 years
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Secondary outcome [14]
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Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations
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Assessment method [14]
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The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to ulcerative colitis since the last visit. The cumulative number of unscheduled utilizations over the course of the study is presented.
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Timepoint [14]
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5 years
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Secondary outcome [15]
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Number of Participants With Adverse Events
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Assessment method [15]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject 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 (SAE) 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
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Timepoint [15]
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From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks)
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Secondary outcome [16]
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Hematology: Mean Change From Baseline to Final Values in Hemoglobin
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Assessment method [16]
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Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
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Timepoint [16]
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Baseline (Week 0), final value (up to 5 years)
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Secondary outcome [17]
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Hematology: Mean Change From Baseline to Final Values in Hematocrit
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Assessment method [17]
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Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
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Timepoint [17]
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Baseline (Week 0), final value (up to 5 years)
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Secondary outcome [18]
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Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils
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Assessment method [18]
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Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
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Timepoint [18]
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Baseline (Week 0), final value (up to 5 years)
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Secondary outcome [19]
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Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase
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Assessment method [19]
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Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
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Timepoint [19]
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Baseline (Week 0), final value (up to 5 years)
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Secondary outcome [20]
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Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid
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Assessment method [20]
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Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
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Timepoint [20]
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Baseline (Week 0), final value (up to 5 years)
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Secondary outcome [21]
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Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides
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Assessment method [21]
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Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
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Timepoint [21]
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Baseline (Week 0), final value (up to 5 years)
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Secondary outcome [22]
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Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein
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Assessment method [22]
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Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
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Timepoint [22]
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Baseline (Week 0), final value (up to 5 years)
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Secondary outcome [23]
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Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein
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Assessment method [23]
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Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
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Timepoint [23]
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Baseline (Week 0), final value (up to 5 years)
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Eligibility
Key inclusion criteria
* Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629)
* Subject is judged to be in generally good health as determined by the principal investigator
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or M06-827 (NCT00408629)
* Subject considered by the investigator, for any reason, to be an unsuitable candidate
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/11/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2016
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Sample size
Target
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Accrual to date
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Final
592
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie (prior sponsor, Abbott)
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).
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Trial website
https://clinicaltrials.gov/study/NCT00573794
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Trial related presentations / publications
Colombel JF, Sandborn WJ, Ghosh S, Wolf DC, Panaccione R, Feagan B, Reinisch W, Robinson AM, Lazar A, Kron M, Huang B, Skup M, Thakkar RB. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014 Nov;109(11):1771-80. doi: 10.1038/ajg.2014.242. Epub 2014 Aug 26. Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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AbbVie Inc
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00573794
Download to PDF