Trial Outcomes & Findings for A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease (NCT NCT01958827)
NCT ID: NCT01958827
Last Updated: 2016-04-12
Results Overview
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
28 participants
Primary outcome timeframe
Week 8
Results posted on
2016-04-12
Participant Flow
This study included a 21-day screening period.
Participant milestones
| Measure |
Adalimumab 80 mg
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Adalimumab 80 mg
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Concomitant Prohibited Medicine for AE
|
1
|
Baseline Characteristics
A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
Baseline characteristics by cohort
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS): All enrolled participants who received at least one dose of study drug and had at least one post-treatment efficacy assessment.
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
|
75 percentage of participants
Interval 55.1 to 89.3
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 4
|
14.3 percentage of participants
Interval 4.0 to 32.7
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 8
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 12
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 16
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 20
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 24
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 28
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 32
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 36
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 40
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 44
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 48
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
|
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
Week 52
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
SECONDARY outcome
Timeframe: Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. Week 8 was the primary outcome measure.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 4
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 12
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 16
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 20
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 24
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 28
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 32
|
71.4 percentage of participants
Interval 51.3 to 86.8
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 36
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 40
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 44
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 48
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
Week 52
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 4
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 8
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 12
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 16
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 20
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 24
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 28
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 32
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 36
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 40
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 44
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 48
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
|
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
Week 52
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 4
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 8
|
35.7 percentage of participants
Interval 18.6 to 55.9
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 12
|
39.3 percentage of participants
Interval 21.5 to 59.4
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 16
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 20
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 24
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 28
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 32
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 36
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 40
|
57.1 percentage of participants
Interval 37.2 to 75.5
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 44
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 48
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
|
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
Week 52
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: FAS
C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age. Last Observation Carried Forward (LOCF) was used for missing data.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 4
|
-0.570 mg/dL
Standard Deviation 1.4902
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 8
|
-0.426 mg/dL
Standard Deviation 1.6072
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 12
|
-0.710 mg/dL
Standard Deviation 1.6769
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 16
|
-0.923 mg/dL
Standard Deviation 1.6981
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 20
|
-0.907 mg/dL
Standard Deviation 1.7532
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 24
|
-0.813 mg/dL
Standard Deviation 1.7924
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 28
|
-0.833 mg/dL
Standard Deviation 1.8820
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 32
|
-0.853 mg/dL
Standard Deviation 2.0507
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 36
|
-0.586 mg/dL
Standard Deviation 2.3271
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 40
|
-1.008 mg/dL
Standard Deviation 2.0471
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 44
|
-0.915 mg/dL
Standard Deviation 2.2324
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 48
|
-0.649 mg/dL
Standard Deviation 2.5734
|
|
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
Week 52
|
-0.570 mg/dL
Standard Deviation 2.7635
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety Analysis Set: All enrolled participants who received at least one dose of study drug.
Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal \[ULN\] or lower than lower limit of normal \[LLN\]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. Increase is signified by ↑. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Number of Participants With Potentially Significant Hematology Parameters
Haemoglobin <8 g/dL (n=27)
|
1 participants
|
|
Number of Participants With Potentially Significant Hematology Parameters
Haemoglobin ↑ >4.0 g/dL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Hematology Parameters
Platelet Count <5.0x10^4/mcL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Hematology Parameters
White Blood Cells <2.0x10^3/mcL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Hematology Parameters
Neutrophils <1.0x10^3/mcL(n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Hematology Parameters
Lymphocytes <0.5x10^3/mcL (n=28)
|
4 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Safety Analysis Set
Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal \[ULN\] or lower than lower limit of normal \[LLN\]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value for each parameter.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Alanine Aminotransferase >5xULN (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Aspartate Aminotransferase >5xULN (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Gamma-glutamyl Transpeptidase >5x ULN (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Alkaline Phosphatase >5xU/L (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Total Bilirubin >3xULN (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Creatine Phosphokinase >5x ULN (n=28)
|
1 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Creatinine >3xULN or >3xBL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Uric Acid >10.0 mg/dL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Inorganic Phosphate <2.0 mg/dL (n=28)
|
3 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Calcium <7.0 mg/dL (n=28)
|
1 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Calcium >12.5 mg/dL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Sodium <130 mEq/L (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Sodium >155 mEq/L (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Potassium <3.0 mEq/L (n=27)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Potassium >6.0 mEq/L (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Non-fasting Glucose <40 mg/dL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Non-fasting Glucose >250 mg/dL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Albumin <2.0 g/dL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Cholesterol >400 mg/dL(n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Triglycerides >500 mg/dL(n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Magnesium <0.9 mg/dL (n=28)
|
0 participants
|
|
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Magnesium >3.0 mg/dL (n=28)
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Analysis Set
Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 2 (n=28)
|
-3.9 mm Hg
Standard Deviation 11.98
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 4 (n=28)
|
-2.5 mm Hg
Standard Deviation 9.41
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 8 (n=25)
|
-1.1 mm Hg
Standard Deviation 9.98
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 12 (n=21)
|
-1.3 mm Hg
Standard Deviation 9.34
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 16 (n=21)
|
-0.2 mm Hg
Standard Deviation 11.72
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 20 (n=20)
|
1.9 mm Hg
Standard Deviation 12.64
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 24 (n=20)
|
2.0 mm Hg
Standard Deviation 8.89
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 28 (n=20)
|
0.8 mm Hg
Standard Deviation 8.91
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 32 (n=20)
|
-1.7 mm Hg
Standard Deviation 7.41
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 36 (n=20)
|
-0.5 mm Hg
Standard Deviation 10.79
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 40 (n=20)
|
2.3 mm Hg
Standard Deviation 9.55
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 44 (n=19)
|
1.9 mm Hg
Standard Deviation 14.12
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 48 (n=19)
|
4.6 mm Hg
Standard Deviation 11.66
|
|
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 52 (n=18)
|
-0.3 mm Hg
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Analysis Set
Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 2 (n=28)
|
-0.6 mm Hg
Standard Deviation 9.53
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 4 (n=28)
|
0.2 mm Hg
Standard Deviation 8.56
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 8 (n=25)
|
0.7 mm Hg
Standard Deviation 8.13
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 12 (n=21)
|
1.1 mm Hg
Standard Deviation 7.12
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 16 (n=21)
|
0.1 mm Hg
Standard Deviation 7.78
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 20 (n=20)
|
0.8 mm Hg
Standard Deviation 9.38
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 24 (n=20)
|
0.8 mm Hg
Standard Deviation 8.72
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 28 (n=20)
|
-0.5 mm Hg
Standard Deviation 7.81
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 32 (n=20)
|
-0.8 mm Hg
Standard Deviation 9.27
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 36 (n=20)
|
-0.4 mm Hg
Standard Deviation 10.27
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 40 (n=20)
|
0.7 mm Hg
Standard Deviation 10.66
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 44 (n=19)
|
-1.2 mm Hg
Standard Deviation 8.57
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 48 (n=19)
|
1.3 mm Hg
Standard Deviation 8.48
|
|
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Week 52 (n=18)
|
3.0 mm Hg
Standard Deviation 11.97
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Analysis Set
Heart rate was measured while the participant was sitting. n=the number of participants with available data at each time point.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 2 (n=28)
|
-0.3 bpm
Standard Deviation 11.94
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 4 (n=28)
|
0.7 bpm
Standard Deviation 12.78
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 8 (n=25)
|
-1.1 bpm
Standard Deviation 9.48
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 12 (n=21)
|
-1.1 bpm
Standard Deviation 11.59
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 16 (n=21)
|
-1.9 bpm
Standard Deviation 9.56
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 20 (n=20)
|
-3.0 bpm
Standard Deviation 8.68
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 24 (n=20)
|
-0.9 bpm
Standard Deviation 13.15
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 28 (n=20)
|
-1.6 bpm
Standard Deviation 11.30
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 32 (n=20)
|
-5.6 bpm
Standard Deviation 11.95
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 36 (n=20)
|
-4.7 bpm
Standard Deviation 12.88
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 40 (n=20)
|
-3.7 bpm
Standard Deviation 13.88
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 44 (n=19)
|
-2.0 bpm
Standard Deviation 10.78
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 48 (n=19)
|
-1.3 bpm
Standard Deviation 15.53
|
|
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Week 52 (n=18)
|
-2.8 bpm
Standard Deviation 11.80
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Safety Analysis Set
n=the number of participants with available data at each time point.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 28 (n=20)
|
-0.23 degrees Celcius
Standard Deviation 0.716
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 32 (n=20)
|
-0.26 degrees Celcius
Standard Deviation 0.762
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 36 (n=20)
|
-0.36 degrees Celcius
Standard Deviation 0.476
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 2 (n=28)
|
-0.03 degrees Celcius
Standard Deviation 0.558
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 4 (n=28)
|
-0.02 degrees Celcius
Standard Deviation 0.571
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 8 (n=25)
|
-0.08 degrees Celcius
Standard Deviation 0.569
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 12 (n=21)
|
-0.14 degrees Celcius
Standard Deviation 0.606
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 16 (n=21)
|
-0.11 degrees Celcius
Standard Deviation 0.558
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 20 (n=20)
|
-0.16 degrees Celcius
Standard Deviation 0.545
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 24 (n=20)
|
-0.20 degrees Celcius
Standard Deviation 0.701
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 40 (n=20)
|
-0.16 degrees Celcius
Standard Deviation 0.555
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 44 (n=19)
|
-0.24 degrees Celcius
Standard Deviation 0.472
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 48 (n=19)
|
-0.03 degrees Celcius
Standard Deviation 0.781
|
|
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
Week 52 (n=18)
|
-0.13 degrees Celcius
Standard Deviation 0.717
|
SECONDARY outcome
Timeframe: 60 weeksPopulation: Safety Analysis Set
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (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 participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Any TEAE
|
24 participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs with reasonable possibility of being related
|
5 participants
|
|
Number of Participants With Adverse Events (AEs)
Any severe TEAE
|
2 participants
|
|
Number of Participants With Adverse Events (AEs)
TESAE
|
8 participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE Leading to Discontinuation of Study
|
4 participants
|
|
Number of Participants With Adverse Events (AEs)
Death
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 0) to Week 52Population: All participants in the FAS with available data at both time points.
Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method. The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha. n=the number of participants with available data at each time point.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
Baseline (Week 0) (n=28)
|
3.06 µg/mL
Standard Deviation 2.19
|
|
Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
Week 52 (n=18)
|
9.47 µg/mL
Standard Deviation 5.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Week 0) to Week 52Population: FAS
Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.
Outcome measures
| Measure |
Adalimumab 80 mg
n=28 Participants
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52
Baseline (Week 0)
|
3 participants
|
|
Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52
Week 52
|
4 participants
|
Adverse Events
Adalimumab 80 mg
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab 80 mg
n=28 participants at risk
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
14.3%
4/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
ILEUS
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
SMALL INTESTINAL ULCER HAEMORRHAGE
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
SUBILEUS
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
ANAL ABSCESS
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Injury, poisoning and procedural complications
ALLERGIC TRANSFUSION REACTION
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
Other adverse events
| Measure |
Adalimumab 80 mg
n=28 participants at risk
All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Ear and labyrinth disorders
VERTIGO
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
CHEILITIS
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
DENTAL CARIES
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
NAUSEA
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Gastrointestinal disorders
STOMATITIS
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
General disorders
INJECTION SITE REACTION
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
General disorders
PYREXIA
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Immune system disorders
SEASONAL ALLERGY
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
ANAL ABSCESS
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
BRONCHITIS
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
CANDIDA INFECTION
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
INFECTION
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
INFLUENZA
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
MYCOPLASMA INFECTION
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
NASOPHARYNGITIS
|
46.4%
13/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
OTITIS EXTERNA
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
PERIODONTITIS
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
PULPITIS DENTAL
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Investigations
BLOOD PRESSURE INCREASED
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Musculoskeletal and connective tissue disorders
TEMPOROMANDIBULAR JOINT SYNDROME
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Nervous system disorders
HEADACHE
|
10.7%
3/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Nervous system disorders
MIGRAINE
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Nervous system disorders
RADICULOPATHY
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Nervous system disorders
SYNCOPE
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Skin and subcutaneous tissue disorders
RASH
|
14.3%
4/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
7.1%
2/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
|
Vascular disorders
HYPERTENSION
|
3.6%
1/28 • AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
|
Additional Information
Global Medical Information
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Restriction type: OTHER