Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis
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).
Interventions
BIOLOGICALadalimumab
adalimumab prefilled syringes administered as subcutaneous injection EW or EOW
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial Mayo Score: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| Mayo Score: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement. |
| Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| Mayo Stool Frequency Subscore: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement. |
| Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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). |
| 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| WPAI:GH Impairment While Working: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| WPAI:GH Activity Impairment: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| Percentage of Participants With Remission Per Partial Mayo Score Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | 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. |
| Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations | 5 years | 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. |
| Number of Participants With Adverse Events | From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks) | 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. |
| Hematology: Mean Change From Baseline to Final Values in Hemoglobin | Baseline (Week 0), final value (up to 5 years) | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. |
| Hematology: Mean Change From Baseline to Final Values in Hematocrit | Baseline (Week 0), final value (up to 5 years) | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. |
| 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 | Baseline (Week 0), final value (up to 5 years) | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. |
| Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase | Baseline (Week 0), final value (up to 5 years) | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. |
| Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid | Baseline (Week 0), final value (up to 5 years) | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. |
| Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Baseline (Week 0), final value (up to 5 years) | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. |
| Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein | Baseline (Week 0), final value (up to 5 years) | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. |
| Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein | Baseline (Week 0), final value (up to 5 years) | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. |
| Colectomy Rate | 5 years | The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy. |
| Mayo Endoscopy Subscore: Change From Baseline Over Time | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 | The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement. |
Participant flow
Pre-assignment details
A total of 592 subjects were randomized and received at least 1 dose of study drug (safety population); 7 subjects enrolled at 3 noncompliant sites were excluded from the analyses (Intent-to-treat 1 \[ITT-1\] population; N=585).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 585 |
| Total | 585 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 81 |
| Overall Study | Lack of Efficacy | 94 |
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Other | 46 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Withdrew Consent | 90 |
Baseline characteristics
| Characteristic | Adalimumab 40 mg EOW/EW |
|---|---|
| Age, Continuous | 41.6 years STANDARD_DEVIATION 12.85 |
| Sex: Female, Male Female | 214 Participants |
| Sex: Female, Male Male | 371 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 391 / 592 |
| serious Total, serious adverse events | 158 / 592 |
Outcome results
Primary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Baseline | 3.5 units on a scale | Standard Deviation 2.72 |
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 48 | -0.3 units on a scale | Standard Deviation 2.64 |
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 96 | -0.5 units on a scale | Standard Deviation 2.49 |
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.8 units on a scale | Standard Deviation 2.73 |
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 192 | -0.8 units on a scale | Standard Deviation 2.52 |
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 240 | -1.0 units on a scale | Standard Deviation 2.4 |
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 292 | -0.9 units on a scale | Standard Deviation 2.84 |
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 340 | -1.3 units on a scale | Standard Deviation 2.87 |
| Adalimumab 40 mg EOW/EW | Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 388 | -2.0 units on a scale | Standard Deviation 1.73 |
Primary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Baseline | 2.5 units on a scale | Standard Deviation 2.02 |
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 48 | -0.2 units on a scale | Standard Deviation 2.04 |
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 96 | -0.4 units on a scale | Standard Deviation 1.78 |
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.5 units on a scale | Standard Deviation 2.06 |
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 192 | -0.6 units on a scale | Standard Deviation 1.84 |
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 240 | -0.8 units on a scale | Standard Deviation 1.79 |
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 292 | -0.7 units on a scale | Standard Deviation 2.05 |
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 340 | -1.0 units on a scale | Standard Deviation 1.97 |
| Adalimumab 40 mg EOW/EW | Partial Mayo Score: Change From Baseline Over Time | Change from Baseline to Week 388 | -2.0 units on a scale | Standard Deviation 1 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Baseline | 47.1 units on a scale | Standard Deviation 10.16 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Change from Baseline to Week 48 | -0.7 units on a scale | Standard Deviation 9.61 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Change from Baseline to Week 96 | 0.3 units on a scale | Standard Deviation 9.64 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Change from Baseline to Week 144 | 0.0 units on a scale | Standard Deviation 9.52 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Change from Baseline to Week 192 | 0.1 units on a scale | Standard Deviation 9.41 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Change from Baseline to Week 240 | 0.7 units on a scale | Standard Deviation 7.86 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Change from Baseline to Week 292 | 1.8 units on a scale | Standard Deviation 8.13 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Change from Baseline to Week 340 | 1.8 units on a scale | Standard Deviation 6.81 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | Change from Baseline to Week 388 | -7.3 units on a scale | Standard Deviation 5.58 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Baseline | 49.3 units on a scale | Standard Deviation 8.06 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Change from Baseline to Week 48 | 0.7 units on a scale | Standard Deviation 6.98 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Change from Baseline to Week 96 | 1.2 units on a scale | Standard Deviation 6.26 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Change from Baseline to Week 144 | 1.1 units on a scale | Standard Deviation 7.08 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Change from Baseline to Week 192 | 1.3 units on a scale | Standard Deviation 7.46 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Change from Baseline to Week 240 | 2.2 units on a scale | Standard Deviation 6.23 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Change from Baseline to Week 292 | 2.5 units on a scale | Standard Deviation 7.03 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Change from Baseline to Week 340 | 3.0 units on a scale | Standard Deviation 8.71 |
| Adalimumab 40 mg EOW/EW | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | Change from Baseline to Week 388 | 8.4 units on a scale | Standard Deviation 2 |
Secondary
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)
Population: Participants in the safety analysis set with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase | Alanine aminotransferase | 3.7 U/L | Standard Deviation 22.03 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase | Aspartate aminotransferase | 2.6 U/L | Standard Deviation 28.13 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase | Alkaline phosphatase | -0.2 U/L | Standard Deviation 34.65 |
Secondary
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)
Population: Participants in the safety analysis set with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein | Albumin | -0.4 g/L | Standard Deviation 3.85 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein | Total protein | 0.7 g/L | Standard Deviation 18.99 |
Secondary
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)
Population: Participants in the safety analysis set with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Blood urea nitrogen | 0.32 mmol/L | Standard Deviation 1.409 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Inorganic phosphate | -0.003 mmol/L | Standard Deviation 0.2312 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Calcium | -0.012 mmol/L | Standard Deviation 0.1185 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Sodium | -0.0 mmol/L | Standard Deviation 2.49 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Potassium | 0.07 mmol/L | Standard Deviation 0.424 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Glucose | 0.05 mmol/L | Standard Deviation 1.334 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Cholesterol | -0.025 mmol/L | Standard Deviation 0.8853 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Triglycerides | 0.178 mmol/L | Standard Deviation 1.28 |
Secondary
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)
Population: Participants in the safety analysis set with both Baseline and visit values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein | 0.382 mg/L | Standard Deviation 15.1489 |
Secondary
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)
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid | Total bilirubin | -1.0 μmol/L | Standard Deviation 5.35 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid | Creatinine | 2.4 μmol/L | Standard Deviation 13.18 |
| Adalimumab 40 mg EOW/EW | Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid | Uric acid | 7.6 μmol/L | Standard Deviation 65.52 |
Secondary
Colectomy Rate
The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.
Time frame: 5 years
Population: ITT-1 population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab 40 mg EOW/EW | Colectomy Rate | 3.88 percentage of participants |
Secondary
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
Population: ITT-1 population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations | Physician | 561 cumulative number of utilizations |
| Adalimumab 40 mg EOW/EW | Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations | Emergency Room | 43 cumulative number of utilizations |
| Adalimumab 40 mg EOW/EW | Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations | Hospital Admission | 65 cumulative number of utilizations |
| Adalimumab 40 mg EOW/EW | Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations | Days in Hospital | 435 cumulative number of utilizations |
Secondary
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)
Population: Participants in the safety analysis set with both Baseline and visit values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Hematology: Mean Change From Baseline to Final Values in Hematocrit | 0.013 Percentage of red blood cells | Standard Deviation 0.0472 |
Secondary
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)
Population: Participants in the safety analysis set with both Baseline and visit values.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Hematology: Mean Change From Baseline to Final Values in Hemoglobin | -0.1 g/L | Standard Deviation 16.02 |
Secondary
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)
Population: Participants in the safety analysis set with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | 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 | Red blood cell count | 0.03 cells * 10^9/L | Standard Deviation 0.416 |
| Adalimumab 40 mg EOW/EW | 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 | Platelet count | -10.5 cells * 10^9/L | Standard Deviation 96.98 |
| Adalimumab 40 mg EOW/EW | 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 | White blood cell count | 0.41 cells * 10^9/L | Standard Deviation 2.704 |
| Adalimumab 40 mg EOW/EW | 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 | Neutrophils | 0.164 cells * 10^9/L | Standard Deviation 2.4225 |
| Adalimumab 40 mg EOW/EW | 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 | Lymphocytes | 0.155 cells * 10^9/L | Standard Deviation 0.827 |
| Adalimumab 40 mg EOW/EW | 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 | Monocytes | 0.051 cells * 10^9/L | Standard Deviation 0.2203 |
| Adalimumab 40 mg EOW/EW | 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 | Eosinophils | 0.002 cells * 10^9/L | Standard Deviation 0.1602 |
| Adalimumab 40 mg EOW/EW | 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 | Basophils | 0.009 cells * 10^9/L | Standard Deviation 0.0586 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Baseline | 176.0 units on a scale | Standard Deviation 34.45 |
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Change from Baseline to Week 48 | 2.1 units on a scale | Standard Deviation 28.91 |
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Change from Baseline to Week 96 | 4.7 units on a scale | Standard Deviation 28.73 |
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Change from Baseline to Week 144 | 5.2 units on a scale | Standard Deviation 30.64 |
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Change from Baseline to Week 192 | 7.6 units on a scale | Standard Deviation 28.66 |
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Change from Baseline to Week 240 | 11.2 units on a scale | Standard Deviation 25.98 |
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Change from Baseline to Week 292 | 14.8 units on a scale | Standard Deviation 27.36 |
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Change from Baseline to Week 340 | 14.6 units on a scale | Standard Deviation 28.12 |
| Adalimumab 40 mg EOW/EW | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | Change from Baseline to Week 388 | 11.0 units on a scale | Standard Deviation 12.53 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Change from Baseline to Week 240 | -0.3 units on a scale | Standard Deviation 0.97 |
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Baseline | 1.1 units on a scale | Standard Deviation 0.94 |
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Change from Baseline to Week 48 | -0.1 units on a scale | Standard Deviation 0.95 |
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Change from Baseline to Week 96 | -0.1 units on a scale | Standard Deviation 1.02 |
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.2 units on a scale | Standard Deviation 0.93 |
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Change from Baseline to Week 192 | -0.3 units on a scale | Standard Deviation 0.98 |
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Change from Baseline to Week 292 | -0.3 units on a scale | Standard Deviation 1.03 |
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Change from Baseline to Week 340 | -0.3 units on a scale | Standard Deviation 1.18 |
| Adalimumab 40 mg EOW/EW | Mayo Endoscopy Subscore: Change From Baseline Over Time | Change from Baseline to Week 388 | 0.0 units on a scale | Standard Deviation 1 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Baseline | 0.8 units on a scale | Standard Deviation 0.81 |
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Change from Baseline to Week 48 | -0.1 units on a scale | Standard Deviation 0.89 |
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Change from Baseline to Week 96 | -0.2 units on a scale | Standard Deviation 0.84 |
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.2 units on a scale | Standard Deviation 0.89 |
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Change from Baseline to Week 192 | -0.2 units on a scale | Standard Deviation 0.82 |
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Change from Baseline to Week 240 | -0.3 units on a scale | Standard Deviation 0.82 |
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Change from Baseline to Week 292 | -0.2 units on a scale | Standard Deviation 0.79 |
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Change from Baseline to Week 340 | -0.3 units on a scale | Standard Deviation 0.88 |
| Adalimumab 40 mg EOW/EW | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | Change from Baseline to Week 388 | -0.7 units on a scale | Standard Deviation 0.58 |
Secondary
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Baseline | 0.4 units on a scale | Standard Deviation 0.68 |
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Change from Baseline to Week 48 | -0.1 units on a scale | Standard Deviation 0.73 |
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Change from Baseline to Week 96 | -0.0 units on a scale | Standard Deviation 0.63 |
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.1 units on a scale | Standard Deviation 0.74 |
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Change from Baseline to Week 192 | -0.1 units on a scale | Standard Deviation 0.69 |
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Change from Baseline to Week 240 | -0.2 units on a scale | Standard Deviation 0.63 |
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Change from Baseline to Week 292 | -0.2 units on a scale | Standard Deviation 0.76 |
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Change from Baseline to Week 340 | -0.2 units on a scale | Standard Deviation 0.8 |
| Adalimumab 40 mg EOW/EW | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | Change from Baseline to Week 388 | -1.0 units on a scale | Standard Deviation 1 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Baseline | 1.3 units on a scale | Standard Deviation 1.01 |
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Change from Baseline to Week 48 | -0.1 units on a scale | Standard Deviation 0.89 |
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Change from Baseline to Week 96 | -0.2 units on a scale | Standard Deviation 0.84 |
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.2 units on a scale | Standard Deviation 0.89 |
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Change from Baseline to Week 192 | -0.2 units on a scale | Standard Deviation 0.82 |
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Change from Baseline to Week 240 | -0.3 units on a scale | Standard Deviation 0.86 |
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Change from Baseline to Week 292 | -0.3 units on a scale | Standard Deviation 1 |
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Change from Baseline to Week 340 | -0.5 units on a scale | Standard Deviation 0.99 |
| Adalimumab 40 mg EOW/EW | Mayo Stool Frequency Subscore: Change From Baseline Over Time | Change from Baseline to Week 388 | -0.3 units on a scale | Standard Deviation 0.58 |
Secondary
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)
Population: Safety analysis set: all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Number of Participants With Adverse Events | Any TEAE | 496 Participants |
| Adalimumab 40 mg EOW/EW | Number of Participants With Adverse Events | Any TESAE | 158 Participants |
Secondary
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
Population: Participants in ITT-1 population with evaluable data at given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Baseline | 52.4 percentage of participants |
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Week 48 | 61.2 percentage of participants |
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Week 96 | 69.3 percentage of participants |
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Week 144 | 75.0 percentage of participants |
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Week 192 | 74.7 percentage of participants |
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Week 240 | 77.2 percentage of participants |
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Week 292 | 76.7 percentage of participants |
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Week 340 | 73.9 percentage of participants |
| Adalimumab 40 mg EOW/EW | Percentage of Participants With Remission Per Partial Mayo Score Over Time | Week 388 | 100 percentage of participants |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Baseline | 4.5 percent of work time missed | Standard Deviation 15.42 |
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Change from Baseline to Week 48 | 1.6 percent of work time missed | Standard Deviation 24.04 |
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Change from Baseline to Week 96 | -0.2 percent of work time missed | Standard Deviation 18.41 |
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Change from Baseline to Week 144 | 0.9 percent of work time missed | Standard Deviation 20.19 |
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Change from Baseline to Week 192 | 0.2 percent of work time missed | Standard Deviation 19.05 |
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Change from Baseline to Week 240 | -1.1 percent of work time missed | Standard Deviation 17.21 |
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Change from Baseline to Week 292 | 8.2 percent of work time missed | Standard Deviation 30.65 |
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Change from Baseline to Week 340 | 6.4 percent of work time missed | Standard Deviation 24.96 |
| Adalimumab 40 mg EOW/EW | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | Change from Baseline to Week 388 | 0.0 percent of work time missed | Standard Deviation 0 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Change from Baseline to Week 240 | -3.4 percent activity impaired | Standard Deviation 18.63 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Baseline | 21.4 percent activity impaired | Standard Deviation 24 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Change from Baseline to Week 48 | 1.1 percent activity impaired | Standard Deviation 24.14 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Change from Baseline to Week 96 | -1.6 percent activity impaired | Standard Deviation 21.8 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.7 percent activity impaired | Standard Deviation 23.65 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Change from Baseline to Week 192 | -2.1 percent activity impaired | Standard Deviation 20.91 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Change from Baseline to Week 292 | -1.5 percent activity impaired | Standard Deviation 19.79 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Change from Baseline to Week 340 | -9.6 percent activity impaired | Standard Deviation 11.86 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Activity Impairment: Change From Baseline Over Time | Change from Baseline to Week 388 | -16.7 percent activity impaired | Standard Deviation 15.28 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Baseline | 16.7 percent of work time impaired | Standard Deviation 20.73 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Change from Baseline to Week 48 | 1.1 percent of work time impaired | Standard Deviation 22.45 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Change from Baseline to Week 96 | -1.9 percent of work time impaired | Standard Deviation 20.86 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.2 percent of work time impaired | Standard Deviation 24.11 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Change from Baseline to Week 192 | -2.9 percent of work time impaired | Standard Deviation 24.04 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Change from Baseline to Week 240 | -4.0 percent of work time impaired | Standard Deviation 21.4 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Change from Baseline to Week 292 | -3.8 percent of work time impaired | Standard Deviation 25.45 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Change from Baseline to Week 340 | -13.8 percent of work time impaired | Standard Deviation 26.04 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Impairment While Working: Change From Baseline Over Time | Change from Baseline to Week 388 | -15.0 percent of work time impaired | Standard Deviation 21.21 |
Secondary
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
Population: Participants in ITT-1 population with both Baseline and visit values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Baseline | 20.1 percent of overall work impairment | Standard Deviation 24.3 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Change from Baseline to Week 48 | 1.2 percent of overall work impairment | Standard Deviation 28.15 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Change from Baseline to Week 96 | -2.7 percent of overall work impairment | Standard Deviation 24.99 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Change from Baseline to Week 144 | -0.8 percent of overall work impairment | Standard Deviation 28.05 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Change from Baseline to Week 192 | -2.6 percent of overall work impairment | Standard Deviation 26.69 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Change from Baseline to Week 240 | -5.0 percent of overall work impairment | Standard Deviation 24.1 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Change from Baseline to Week 292 | 1.4 percent of overall work impairment | Standard Deviation 35.53 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Change from Baseline to Week 340 | -7.3 percent of overall work impairment | Standard Deviation 12.05 |
| Adalimumab 40 mg EOW/EW | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | Change from Baseline to Week 388 | -15.0 percent of overall work impairment | Standard Deviation 21.21 |