Trial Outcomes & Findings for Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS) (NCT NCT00427921)
NCT ID: NCT00427921
Last Updated: 2009-11-20
Results Overview
Extent of exposure for all adalimumab treated subjects
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2009-11-20
Participant Flow
Participant milestones
| Measure |
40 mg Adalimumab Every Other Week
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Overall Study
STARTED
|
304
|
|
Overall Study
COMPLETED
|
254
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
40 mg Adalimumab Every Other Week
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Overall Study
Adverse Event
|
26
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other reason not specified
|
10
|
|
Overall Study
Adverse Event + Hospitalization
|
1
|
|
Overall Study
Adverse Event + Withdrew Consent
|
1
|
|
Overall Study
Adverse Event + No Response
|
1
|
|
Overall Study
Adverse Event + Worsening of CD
|
1
|
|
Overall Study
Adverse Event + No Therapeutic Benefit
|
1
|
|
Overall Study
Adverse Event + Lost Response
|
1
|
|
Overall Study
Adverse Event + Withdrawn from Study
|
1
|
|
Overall Study
Withdrew Consent + Lack of Efficacy
|
1
|
Baseline Characteristics
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
Baseline characteristics by cohort
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
296 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
291 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
304 Participants
n=5 Participants
|
|
Alcohol
User
|
147 participants
n=5 Participants
|
|
Alcohol
Ex-User
|
15 participants
n=5 Participants
|
|
Alcohol
Non-User
|
142 participants
n=5 Participants
|
|
C-Reactive protein mg/dL
< 1.0 mg/dL
|
148 participants
n=5 Participants
|
|
C-Reactive protein mg/dL
> = 1.0 mg/dL
|
155 participants
n=5 Participants
|
|
C-Reactive protein mg/dL
Missing
|
1 participants
n=5 Participants
|
|
Nicotine
User
|
98 participants
n=5 Participants
|
|
Nicotine
Ex-User
|
84 participants
n=5 Participants
|
|
Nicotine
Non-User
|
122 participants
n=5 Participants
|
|
Number Subjects With Draining Cutaneous Fistulas at Screening
Count 0 lesions
|
235 participants
n=5 Participants
|
|
Number Subjects With Draining Cutaneous Fistulas at Screening
Count 1 lesion
|
42 participants
n=5 Participants
|
|
Number Subjects With Draining Cutaneous Fistulas at Screening
Count 2 lesions
|
16 participants
n=5 Participants
|
|
Number Subjects With Draining Cutaneous Fistulas at Screening
Count 3 lesions
|
5 participants
n=5 Participants
|
|
Number Subjects With Draining Cutaneous Fistulas at Screening
Count >=4 lesions
|
5 participants
n=5 Participants
|
|
Number Subjects With Draining Cutaneous Fistulas at Screening
Missing
|
1 participants
n=5 Participants
|
|
Number Subjects with Perianal Fistulas at Screening
Count 0
|
244 Participants
n=5 Participants
|
|
Number Subjects with Perianal Fistulas at Screening
Count 1
|
35 Participants
n=5 Participants
|
|
Number Subjects with Perianal Fistulas at Screening
Count 2
|
17 Participants
n=5 Participants
|
|
Number Subjects with Perianal Fistulas at Screening
Count 3
|
4 Participants
n=5 Participants
|
|
Number Subjects with Perianal Fistulas at Screening
Count >=4
|
3 Participants
n=5 Participants
|
|
Number Subjects with Perianal Fistulas at Screening
Missing
|
1 Participants
n=5 Participants
|
|
Number of Subjects with Abdominal Fistulas at Screening
Count 0
|
291 Participants
n=5 Participants
|
|
Number of Subjects with Abdominal Fistulas at Screening
Count 1
|
10 Participants
n=5 Participants
|
|
Number of Subjects with Abdominal Fistulas at Screening
Count 2
|
1 Participants
n=5 Participants
|
|
Number of Subjects with Abdominal Fistulas at Screening
Count 3
|
0 Participants
n=5 Participants
|
|
Number of Subjects with Abdominal Fistulas at Screening
Count >=4
|
1 Participants
n=5 Participants
|
|
Number of Subjects with Abdominal Fistulas at Screening
Missing
|
1 Participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon
|
40 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Gastroduodenum
|
1 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Rectum
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Jejunum
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Ileum
|
54 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Other
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Ileum + Other
|
7 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Jejunum + Ileum
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Rectum + Ileum
|
7 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Rectum + Ileum + Other
|
1 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Gastroduodenum + Ileum
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon + Other
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon + Ileum
|
64 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon + Ileum + Other
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon + Jejunum + Ileum
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon + Rectum
|
8 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon + Rectum + Ileum
|
13 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon + Rectum + Ileum + Other
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon + Gastroduodenum + Ileum
|
1 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon+GD+Jejunum+Ileum
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon+GD+Rectum+ Other
|
1 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Colon+GD+Rectum+Jejunum+Ileum
|
1 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Ileum
|
16 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Ileum + Other
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Jejunum + Ileum
|
1 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Rectum
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Rectum + Other
|
1 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Rectum + Ileum
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon
|
6 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + Other
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + Ileum
|
13 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + Ileum + Other
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + Jejunum + Ileum
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + Rectum
|
3 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + Rectum + Ileum
|
13 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + Rectum + Ileum + Other
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + Rectum +Jejunum + Ileum
|
1 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + GD + Ileum
|
4 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal + Colon + GD +Rectum + Ileum
|
2 participants
n=5 Participants
|
|
Summary of Locations of Crohn's Disease at Screening (All Treated Subjects)
Anal/Perianal+Colon+GD+Rectum+Jejunum+Ileum
|
1 participants
n=5 Participants
|
|
Weight in kilograms
< = 70 kg
|
163 Participants
n=5 Participants
|
|
Weight in kilograms
> 70 kg
|
141 Participants
n=5 Participants
|
|
Duration of Crohn's Disease at Screening in Years
|
11.8 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
Extent of exposure for all adalimumab treated subjects
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Mean Extent of Exposure - Duration in Days
|
159.2 days
Standard Deviation 34.78
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
Extent of exposure for all adalimumab treated subjects
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Total Number of Injections of Adalimumab
Number of Injections During Induction Therapy
|
2 injections
Standard Deviation 0.1
|
|
Total Number of Injections of Adalimumab
Number of Injections During Maintenance Therapy
|
11.8 injections
Standard Deviation 4.24
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
Treatment compliance (%) = 100 \* (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.
|
98.85 Percentage of injections
Standard Deviation 4.207
|
SECONDARY outcome
Timeframe: Week 12, Week 24, and Last Assessment Value (last nonmissing value)Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).
Week 12
|
-0.17 number of fistulas
Standard Deviation 0.644
|
|
Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).
Week 24
|
-0.15 number of fistulas
Standard Deviation 0.587
|
|
Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).
Last Assessment Value
|
-0.15 number of fistulas
Standard Deviation 0.567
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
From the "Overall Health Care Resource Utilization Questionnaire": Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Overall Health Care Resource Utilization
Number of visits to a physician
|
1.13 number of visits
Standard Deviation 2.794
|
|
Overall Health Care Resource Utilization
Number of visits to Emergency Room
|
0.17 number of visits
Standard Deviation 0.522
|
|
Overall Health Care Resource Utilization
Number of hospital admissions
|
0.10 number of visits
Standard Deviation 0.346
|
|
Overall Health Care Resource Utilization
Number of days of hospitalizations
|
0.60 number of visits
Standard Deviation 2.790
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)Population: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
Summary of employment status of those employed.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Employment Status: Number of Subjects Employed
Week 24
|
190 participants
|
|
Employment Status: Number of Subjects Employed
Baseline
|
195 participants
64.1
|
|
Employment Status: Number of Subjects Employed
Week 4
|
199 participants
|
|
Employment Status: Number of Subjects Employed
Week 8
|
198 participants
|
|
Employment Status: Number of Subjects Employed
Week 12
|
192 participants
|
|
Employment Status: Number of Subjects Employed
Last Assessment Value
|
208 participants
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Last Assessment Value (last nonmissing value)Population: Intent To Treat
Decrease in draining fistula is beneficial. "50 percent improvement" refers to a reduction in the number of baseline fistula by 50 percent.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=62 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
50% Improvement in Draining Fistula Count and Fistula Healing
Week 12 50% Improvement in draining fistula
|
35 participants
|
|
50% Improvement in Draining Fistula Count and Fistula Healing
Week 24 50% Improvement in draining fistula
|
31 participants
|
|
50% Improvement in Draining Fistula Count and Fistula Healing
Last Value 50% Improvement in draining fistula
|
32 participants
|
|
50% Improvement in Draining Fistula Count and Fistula Healing
Week 12 Fistula Healing
|
23 participants
|
|
50% Improvement in Draining Fistula Count and Fistula Healing
Week 24 Fistula Healing
|
27 participants
|
|
50% Improvement in Draining Fistula Count and Fistula Healing
Last Assessment Value Fistula Healing
|
28 participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)Population: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity). Minimal clinically important difference = 7 points. Measure is Mean percent change.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment
Week 4
|
-22.08 Units on scale
Standard Deviation 28.454
|
|
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment
Week 8
|
-22.36 Units on scale
Standard Deviation 29.337
|
|
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment
Week 12
|
-29.93 Units on scale
Standard Deviation 33.669
|
|
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment
Week 24
|
-31.23 Units on scale
Standard Deviation 30.403
|
|
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment
Last Assessment Value
|
-28.49 Units on scale
Standard Deviation 32.286
|
SECONDARY outcome
Timeframe: Up to 24 weeksChanges from the Group mean at baseline are compared to the final visit Group mean value
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Hematology - Change From Baseline to Final Visit
Hemoglobin (g/L)
|
2.2 number
Standard Deviation 12.43
|
|
Hematology - Change From Baseline to Final Visit
Hematocrit (fraction)
|
0.011 number
Standard Deviation 0.0376
|
|
Hematology - Change From Baseline to Final Visit
Red blood cell count (x10^9/L)
|
0.03 number
Standard Deviation 0.353
|
|
Hematology - Change From Baseline to Final Visit
Platelet Count (x10^9/L)
|
-30.2 number
Standard Deviation 89.28
|
|
Hematology - Change From Baseline to Final Visit
White blood cell count (x10^9/L)
|
-1.59 number
Standard Deviation 3.297
|
|
Hematology - Change From Baseline to Final Visit
Neutrophils (x10^9/L)
|
-2.005 number
Standard Deviation 3.1777
|
|
Hematology - Change From Baseline to Final Visit
Lymphocytes (x10^9/L)
|
0.408 number
Standard Deviation 0.7285
|
|
Hematology - Change From Baseline to Final Visit
Monocytes (x10^9/L)
|
-0.014 number
Standard Deviation 0.1725
|
|
Hematology - Change From Baseline to Final Visit
Eosinophils (x10^9/L)
|
0.009 number
Standard Deviation 0.1505
|
|
Hematology - Change From Baseline to Final Visit
Basophils (x10^9/L)
|
-0.015 number
Standard Deviation 0.0617
|
SECONDARY outcome
Timeframe: Up to 24 weeksChanges from the Group mean at Baseline are compared to the final visit Group mean value
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Clinical Chemistry - Change From Baseline to Final Visit
SGPT/ALT (U/L)
|
0.6 number
Standard Deviation 17.89
|
|
Clinical Chemistry - Change From Baseline to Final Visit
SGOT/ALT (U/L)
|
1.6 number
Standard Deviation 10.35
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Alkaline phosphatase (U/L)
|
-5.2 number
Standard Deviation 21.53
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Total Bilirubin (mcmol/L)
|
1.6 number
Standard Deviation 4.06
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Creatinine (mcmol/L)
|
1.7 number
Standard Deviation 10.35
|
|
Clinical Chemistry - Change From Baseline to Final Visit
BUN (mmol/L)
|
0.06 number
Standard Deviation 1.367
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Uric acid (mcmol/L)
|
4.6 number
Standard Deviation 52.38
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Inorganic phosphate
|
0.016 number
Standard Deviation 0.2588
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Calcium (mmol/L)
|
0.008 number
Standard Deviation 0.1189
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Sodium (mmol/L)
|
-0.3 number
Standard Deviation 2.38
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Potassium (mmol/L)
|
-0.00 number
Standard Deviation 0.779
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Albumin (G/L)
|
0.4 number
Standard Deviation 4.01
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Total protein (G/L)
|
0.8 number
Standard Deviation 4.83
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Cholesterol (mmol/L)
|
0.021 number
Standard Deviation 0.7024
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Triglycerides (mmol/L)
|
0.093 number
Standard Deviation 0.7581
|
|
Clinical Chemistry - Change From Baseline to Final Visit
C-reactive protein (mg/L)
|
-8.181 number
Standard Deviation 28.7023
|
|
Clinical Chemistry - Change From Baseline to Final Visit
Glucose - fasting (mmol/L)
|
-0.268 number
Standard Deviation 1.3893
|
SECONDARY outcome
Timeframe: Up to 24 weeksChanges from the Group mean at baseline are compared to the final visit Group mean value
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Urinalysis - Change From Baseline to Final Visit
Specific gravity
|
-0.0004 number
Standard Deviation 0.00713
|
|
Urinalysis - Change From Baseline to Final Visit
Urine pH
|
0.02 number
Standard Deviation 0.980
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)Population: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism
Week 4
|
-5.99 units on a scale
Standard Deviation 24.592
|
|
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism
Week 8
|
-7.55 units on a scale
Standard Deviation 27.543
|
|
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism
Week 12
|
-8.74 units on a scale
Standard Deviation 33.477
|
|
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism
Week 24
|
-8.54 units on a scale
Standard Deviation 27.260
|
|
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism
Last Assessment Value
|
-6.46 units on a scale
Standard Deviation 29.167
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)Population: In addition to the ITT population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism
Week 4
|
-20.58 Units on scale
Standard Deviation 26.115
|
|
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism
Week 8
|
-19.94 Units on scale
Standard Deviation 27.151
|
|
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism
Week 12
|
-25.79 Units on scale
Standard Deviation 30.113
|
|
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism
Week 24
|
-28.96 Units on scale
Standard Deviation 28.472
|
|
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism
Last Assessment Value
|
-26.69 Units on scale
Standard Deviation 30.058
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)Population: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment
Week 4
|
-23.59 Units on scale
Standard Deviation 26.928
|
|
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment
Week 8
|
-24.79 Units on scale
Standard Deviation 28.431
|
|
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment
Week 12
|
-30.36 Units on scale
Standard Deviation 28.697
|
|
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment
Week 24
|
-34.00 Units on scale
Standard Deviation 29.552
|
|
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment
Last Assessment Value
|
-30.98 Units on scale
Standard Deviation 30.484
|
POST_HOC outcome
Timeframe: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)Population: Intent to Treat - subjects who received at least one dose of study drug.
HBI score (range 0-30) sum subtotal of 5 parameters of subject's CD activity: a)Well being 0=very well-4=terrible b) Abdominal pain 0=none- 3=severe c) Number liquid stools per day d) Abdominal mass 0=none-3=tender e) Complications: 1 point each. Decrease indicates improvement. Absolute decrease of 3 units on scale is clinically important.
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Harvey-Bradshaw Index (HBI) Mean Change From Baseline
Week 4
|
-4.39 Units on scale
Interval -4.94 to -3.84
|
|
Harvey-Bradshaw Index (HBI) Mean Change From Baseline
Week 8
|
-4.53 Units on scale
95% Confidence Interval 5.175 • Interval -5.12 to -3.93
|
|
Harvey-Bradshaw Index (HBI) Mean Change From Baseline
Week 12
|
-5.32 Units on scale
95% Confidence Interval 5.008 • Interval -5.9 to -4.74
|
|
Harvey-Bradshaw Index (HBI) Mean Change From Baseline
Week 24
|
-6.36 Units on scale
95% Confidence Interval 5.031 • Interval -6.96 to -5.75
|
|
Harvey-Bradshaw Index (HBI) Mean Change From Baseline
Last Assessment Value
|
-5.92 Units on scale
95% Confidence Interval 5.162 • Interval -6.5 to -5.34
|
POST_HOC outcome
Timeframe: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)Population: In addition to the Intent To Treat population, summaries for outcome measures were provided for the analyzable subsets, and subjects in the Per-Protocol analysis set.
Quality of life questionnaire for patients with IBD consisting of 4 domains: systemic, social, emotional, and bowel. This is a 10-item questionnaire, and all items are reported with a 7-point scale (ranging from 1 = poor HRQOL, to 7 = optimum HRQOL). Total SIBDQ score ranges from 10 (quality of life has been negatively affected tremendously by IBD) to 70 (quality of life is barely impacted by IBD). A change greater than 9 points was the minimal clinically important difference (MCID).
Outcome measures
| Measure |
40 mg Adalimumab Every Other Week
n=304 Participants
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline
Week 4
|
10.16 units on a scale
Standard Deviation 10.692
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline
Week 8
|
11.85 units on a scale
Standard Deviation 11.591
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline
Week 12
|
13.14 units on a scale
Standard Deviation 11.783
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline
Week 24
|
15.06 units on a scale
Standard Deviation 12.209
|
|
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Mean Change From Baseline
Last Assessment Value
|
13.74 units on a scale
Standard Deviation 12.629
|
Adverse Events
40 mg Adalimumab Every Other Week
Serious events: 44 serious events
Other events: 133 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
40 mg Adalimumab Every Other Week
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Blood and lymphatic system disorders
anaemia
|
0.99%
3/304
|
|
Blood and lymphatic system disorders
heparin-induced thrombocytopenia
|
0.33%
1/304
|
|
Cardiac disorders
atroventricular block complete
|
0.33%
1/304
|
|
Gastrointestinal disorders
abdominal pain
|
0.66%
2/304
|
|
Gastrointestinal disorders
Crohn's Disease
|
4.3%
13/304
|
|
Gastrointestinal disorders
GI haemorrhage
|
0.33%
1/304
|
|
Gastrointestinal disorders
GI motility disorder
|
0.33%
1/304
|
|
Gastrointestinal disorders
ileal perforation
|
0.33%
1/304
|
|
Gastrointestinal disorders
internal hernia
|
0.33%
1/304
|
|
Gastrointestinal disorders
small intestinal obstruction
|
3.0%
9/304
|
|
Gastrointestinal disorders
subileus
|
0.66%
2/304
|
|
General disorders
death
|
0.33%
1/304
|
|
General disorders
fatigue
|
0.33%
1/304
|
|
General disorders
inflammation
|
0.33%
1/304
|
|
Infections and infestations
abdominal abscess
|
1.3%
4/304
|
|
Infections and infestations
appendicitis
|
0.33%
1/304
|
|
Infections and infestations
perianal abscess
|
0.33%
1/304
|
|
Infections and infestations
pneumonia legionella
|
0.33%
1/304
|
|
Infections and infestations
rectal abscess
|
0.33%
1/304
|
|
Injury, poisoning and procedural complications
anastomotic complication
|
0.33%
1/304
|
|
Infections and infestations
anatomotic leak
|
0.33%
1/304
|
|
Injury, poisoning and procedural complications
anastomotic stenosis
|
0.33%
1/304
|
|
Investigations
haemoglobin decreased
|
0.33%
1/304
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc protrusion
|
0.33%
1/304
|
|
Musculoskeletal and connective tissue disorders
fistula
|
0.33%
1/304
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung adenocarcinoma metastatic
|
0.33%
1/304
|
|
Psychiatric disorders
anxiety
|
0.33%
1/304
|
|
Renal and urinary disorders
nephrolithiasis
|
0.33%
1/304
|
|
Renal and urinary disorders
renal colic
|
0.33%
1/304
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.33%
1/304
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.33%
1/304
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary emolism
|
0.33%
1/304
|
|
Skin and subcutaneous tissue disorders
dyshidrosis
|
0.33%
1/304
|
Other adverse events
| Measure |
40 mg Adalimumab Every Other Week
Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.6%
23/304
|
|
Gastrointestinal disorders
Nausea
|
6.2%
19/304
|
|
Nervous system disorders
Headache
|
6.2%
19/304
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
18/304
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
15/304
|
|
General disorders
Fatigue
|
4.6%
14/304
|
|
General disorders
Injection site reaction
|
7.6%
23/304
|
|
Gastrointestinal disorders
Crohn's Disease
|
16.1%
49/304
|
Additional Information
Medical Information Specialist
Abbott Laboratories
Phone: Phone: (800) 633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Responsibility of preparation and maintenance of the single database, first publication, and, presentation of Study shall reside with Abbott. No independent manuscript may be submitted for publication until first manuscript has been accepted for publication or twelve (12) months after completion of the Study at all sites, which ever occurs first.
- Publication restrictions are in place
Restriction type: OTHER