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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
592
adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
Partial Mayo Score: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Score: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Percentage of Participants With Remission Per Partial Mayo Score Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Endoscopy Subscore: Change From Baseline Over Time
The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time
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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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Mayo Stool Frequency Subscore: Change From Baseline Over Time
The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time
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).
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
WPAI:GH Impairment While Working: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
WPAI:GH Overall Work Impairment: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
WPAI:GH Activity Impairment: Change From Baseline Over Time
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.
Time frame: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388
Colectomy Rate
The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.
Time frame: 5 years
Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations
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.
Time frame: 5 years
Number of Participants With Adverse Events
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.
Time frame: From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks)
Hematology: Mean Change From Baseline to Final Values in Hemoglobin
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Time frame: Baseline (Week 0), final value (up to 5 years)
Hematology: Mean Change From Baseline to Final Values in Hematocrit
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Time frame: Baseline (Week 0), final value (up to 5 years)
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
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Time frame: Baseline (Week 0), final value (up to 5 years)
Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Time frame: Baseline (Week 0), final value (up to 5 years)
Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Time frame: Baseline (Week 0), final value (up to 5 years)
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Time frame: Baseline (Week 0), final value (up to 5 years)
Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Time frame: Baseline (Week 0), final value (up to 5 years)
Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein
Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.
Time frame: Baseline (Week 0), final value (up to 5 years)