Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)
Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT01960790
Collaborator
(none)
473
47.7
Study Details
Study Description
Brief Summary
This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease.
-
Incidence and conditions of occurrence of adverse reactions in clinical practice
-
Factors likely to affect the safety and effectiveness
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
473 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Humira® 40mg Syringe 0.8mL Subcutaneous Injection Special Investigation in Patients With Intestinal Behcet's Disease
Study Start Date
:
May 25, 2013
Actual Primary Completion Date
:
May 15, 2017
Actual Study Completion Date
:
May 15, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants who received Humira® Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Drug Reactions [Up to Week 156]
The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.
Secondary Outcome Measures
- Global Assessment of Gastrointestinal Symptoms [Up to Week 156]
Study participants completed a global assessment of their gastrointestinal symptoms on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life.
- Global Assessment of Gastrointestinal Symptoms of Behcet's Disease [Up to Week 156]
Study participants completed a global assessment of their gastrointestinal symptoms (including abdominal pain, diarrhea and other gastrointestinal symptoms such as abdominal distension, abdominal tenderness, and hemorrhage) on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life.
- Number of Participants With Cardinal Symptoms of Behcet's Disease [Up to Week 156]
The presence or absence of symptoms including recurrent aphthous ulcers of oral mucosa, cutaneous symptoms, eye symptoms and ulceration of vulva was assessed at weeks 52, 104 and 156 against presence or absence at baseline.
- Number of Participants With Accessory Symptoms of Behcet's Disease [Up to Week 156]
The presence or absence of symptoms including arthritis without deformity or stiffness, epididymitis, vascular lesions and moderate to severe central nervous system (CNS) lesions was assessed at weeks 52, 104 and 156 against presence or absence at baseline.
- Number of Participants With Degree of Improvement of Endoscopic Findings [Up to Week 156]
The number of participants with improvement in endoscopic findings is assessed.
- Changes in C-reactive Protein (CRP) [Up to Week 156]
The change in CRP from baseline through the end of the study was assessed.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator)
Exclusion Criteria:
Contraindications according to the Package Insert include patients who had any of the following:
-
serious infections
-
tuberculosis
-
a history of hypersensitivity to any ingredient of Humira®
-
demyelinating disease or a history of demyelinating disease
-
congestive cardiac failure
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: Osamu Mikami, MD, AbbVie GK.
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT01960790
Other Study ID Numbers:
- P14-152
First Posted:
Oct 11, 2013
Last Update Posted:
Mar 22, 2019
Last Verified:
May 1, 2018
Keywords provided by AbbVie
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 473 participants were enrolled in the study; 462 participants were analyzed for safety and 383 participants were analyzed for efficacy. |
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Period Title: Overall Study | |
| STARTED | 473 |
| COMPLETED | 462 |
| NOT COMPLETED | 11 |
Baseline Characteristics
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Overall Participants | 462 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
46.3
(17.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
225
48.7%
|
| Male |
236
51.1%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
461
99.8%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
0
0%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
1
0.2%
|
Outcome Measures
| Title | Number of Participants With Adverse Drug Reactions |
|---|---|
| Description | The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed. |
| Time Frame | Up to Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set: All participants who received at least one administration of Humira® during the study (after informed consent or first administration of Humira®) and for 70 days following the last scheduled administration of Humira®. |
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Measure Participants | 462 |
| Infections and infestations |
47
10.2%
|
| Neoplasms benign, malignant and unspecified |
5
1.1%
|
| Blood and lymphatic system disorders |
6
1.3%
|
| Immune system disorders |
1
0.2%
|
| Endocrine disorders |
3
0.6%
|
| Metabolism and nutrition disorders |
1
0.2%
|
| Psychiatric disorders |
3
0.6%
|
| Nervous system disorders |
7
1.5%
|
| Eye disorders |
1
0.2%
|
| Vascular disorders |
5
1.1%
|
| Respiratory, thoracic and mediastinal disorders |
9
1.9%
|
| Gastrointestinal Disorders |
20
4.3%
|
| Hepatobiliary disorders |
4
0.9%
|
| Skin and subcutaneous tissue disorder |
6
1.3%
|
| Musculoskeletal and connective tissue disorder |
9
1.9%
|
| Pregnancy, puerperium and perinatal conditions |
1
0.2%
|
| General disorders and adminstration site condition |
19
4.1%
|
| Investigations |
22
4.8%
|
| Injury, poisoning and procedural complications |
1
0.2%
|
| Title | Global Assessment of Gastrointestinal Symptoms |
|---|---|
| Description | Study participants completed a global assessment of their gastrointestinal symptoms on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life. |
| Time Frame | Up to Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. |
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Measure Participants | 383 |
| Global assessment score = 0 |
52
11.3%
|
| Global assessment score = 1 |
55
11.9%
|
| Global assessment score = 2 |
76
16.5%
|
| Global assessment score = 3 |
88
19%
|
| Global assessment score = 4 |
98
21.2%
|
| Global assessment score = 0 |
153
33.1%
|
| Global assessment score = 1 |
85
18.4%
|
| Global assessment score = 2 |
44
9.5%
|
| Global assessment score = 3 |
33
7.1%
|
| Global assessment score = 4 |
8
1.7%
|
| Global assessment score = 0 |
176
38.1%
|
| Global assessment score = 1 |
72
15.6%
|
| Global assessment score = 2 |
38
8.2%
|
| Global assessment score = 3 |
19
4.1%
|
| Global assessment score = 4 |
10
2.2%
|
| Global assessment score = 0 |
169
36.6%
|
| Global assessment score = 1 |
72
15.6%
|
| Global assessment score = 2 |
32
6.9%
|
| Global assessment score = 3 |
12
2.6%
|
| Global assessment score = 4 |
7
1.5%
|
| Global assessment score = 0 |
152
32.9%
|
| Global assessment score = 1 |
44
9.5%
|
| Global assessment score = 2 |
34
7.4%
|
| Global assessment score = 3 |
8
1.7%
|
| Global assessment score = 4 |
2
0.4%
|
| Global assessment score = 0 |
142
30.7%
|
| Global assessment score = 1 |
45
9.7%
|
| Global assessment score = 2 |
22
4.8%
|
| Global assessment score = 3 |
10
2.2%
|
| Global assessment score = 4 |
2
0.4%
|
| Global assessment score = 0 |
112
24.2%
|
| Global assessment score = 1 |
38
8.2%
|
| Global assessment score = 2 |
18
3.9%
|
| Global assessment score = 3 |
8
1.7%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
113
24.5%
|
| Global assessment score = 1 |
39
8.4%
|
| Global assessment score = 2 |
17
3.7%
|
| Global assessment score = 3 |
3
0.6%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
29
6.3%
|
| Global assessment score = 1 |
12
2.6%
|
| Global assessment score = 2 |
8
1.7%
|
| Global assessment score = 3 |
0
0%
|
| Global assessment score = 4 |
1
0.2%
|
| Global assessment score = 0 |
32
6.9%
|
| Global assessment score = 1 |
8
1.7%
|
| Global assessment score = 2 |
9
1.9%
|
| Global assessment score = 3 |
0
0%
|
| Global assessment score = 4 |
0
0%
|
| Title | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease |
|---|---|
| Description | Study participants completed a global assessment of their gastrointestinal symptoms (including abdominal pain, diarrhea and other gastrointestinal symptoms such as abdominal distension, abdominal tenderness, and hemorrhage) on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life. |
| Time Frame | Up to Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. |
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Measure Participants | 368 |
| Global assessment score = 0 |
89
19.3%
|
| Global assessment score = 1 |
56
12.1%
|
| Global assessment score = 2 |
74
16%
|
| Global assessment score = 3 |
82
17.7%
|
| Global assessment score = 4 |
67
14.5%
|
| Global assessment score = 0 |
181
39.2%
|
| Global assessment score = 1 |
69
14.9%
|
| Global assessment score = 2 |
39
8.4%
|
| Global assessment score = 3 |
27
5.8%
|
| Global assessment score = 4 |
6
1.3%
|
| Global assessment score = 0 |
202
43.7%
|
| Global assessment score = 1 |
59
12.8%
|
| Global assessment score = 2 |
28
6.1%
|
| Global assessment score = 3 |
20
4.3%
|
| Global assessment score = 4 |
5
1.1%
|
| Global assessment score = 0 |
193
41.8%
|
| Global assessment score = 1 |
54
11.7%
|
| Global assessment score = 2 |
26
5.6%
|
| Global assessment score = 3 |
13
2.8%
|
| Global assessment score = 4 |
6
1.3%
|
| Global assessment score = 0 |
174
37.7%
|
| Global assessment score = 1 |
28
6.1%
|
| Global assessment score = 2 |
29
6.3%
|
| Global assessment score = 3 |
6
1.3%
|
| Global assessment score = 4 |
2
0.4%
|
| Global assessment score = 0 |
158
34.2%
|
| Global assessment score = 1 |
31
6.7%
|
| Global assessment score = 2 |
21
4.5%
|
| Global assessment score = 3 |
10
2.2%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
129
27.9%
|
| Global assessment score = 1 |
26
5.6%
|
| Global assessment score = 2 |
14
3%
|
| Global assessment score = 3 |
8
1.7%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
132
28.6%
|
| Global assessment score = 1 |
31
6.7%
|
| Global assessment score = 2 |
8
1.7%
|
| Global assessment score = 3 |
2
0.4%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
36
7.8%
|
| Global assessment score = 1 |
8
1.7%
|
| Global assessment score = 2 |
4
0.9%
|
| Global assessment score = 3 |
1
0.2%
|
| Global assessment score = 4 |
1
0.2%
|
| Global assessment score = 0 |
36
7.8%
|
| Global assessment score = 1 |
5
1.1%
|
| Global assessment score = 2 |
8
1.7%
|
| Global assessment score = 3 |
0
0%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
167
36.1%
|
| Global assessment score = 1 |
61
13.2%
|
| Global assessment score = 2 |
54
11.7%
|
| Global assessment score = 3 |
50
10.8%
|
| Global assessment score = 4 |
36
7.8%
|
| Global assessment score = 0 |
226
48.9%
|
| Global assessment score = 1 |
52
11.3%
|
| Global assessment score = 2 |
27
5.8%
|
| Global assessment score = 3 |
14
3%
|
| Global assessment score = 4 |
3
0.6%
|
| Global assessment score = 0 |
232
50.2%
|
| Global assessment score = 1 |
54
11.7%
|
| Global assessment score = 2 |
18
3.9%
|
| Global assessment score = 3 |
7
1.5%
|
| Global assessment score = 4 |
3
0.6%
|
| Global assessment score = 0 |
221
47.8%
|
| Global assessment score = 1 |
37
8%
|
| Global assessment score = 2 |
26
5.6%
|
| Global assessment score = 3 |
5
1.1%
|
| Global assessment score = 4 |
3
0.6%
|
| Global assessment score = 0 |
181
39.2%
|
| Global assessment score = 1 |
35
7.6%
|
| Global assessment score = 2 |
21
4.5%
|
| Global assessment score = 3 |
2
0.4%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
176
38.1%
|
| Global assessment score = 1 |
28
6.1%
|
| Global assessment score = 2 |
12
2.6%
|
| Global assessment score = 3 |
4
0.9%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
131
28.4%
|
| Global assessment score = 1 |
31
6.7%
|
| Global assessment score = 2 |
10
2.2%
|
| Global assessment score = 3 |
5
1.1%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
135
29.2%
|
| Global assessment score = 1 |
26
5.6%
|
| Global assessment score = 2 |
10
2.2%
|
| Global assessment score = 3 |
2
0.4%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
36
7.8%
|
| Global assessment score = 1 |
11
2.4%
|
| Global assessment score = 2 |
3
0.6%
|
| Global assessment score = 3 |
0
0%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
37
8%
|
| Global assessment score = 1 |
8
1.7%
|
| Global assessment score = 2 |
4
0.9%
|
| Global assessment score = 3 |
0
0%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
124
26.8%
|
| Global assessment score = 1 |
54
11.7%
|
| Global assessment score = 2 |
61
13.2%
|
| Global assessment score = 3 |
68
14.7%
|
| Global assessment score = 4 |
61
13.2%
|
| Global assessment score = 0 |
219
47.4%
|
| Global assessment score = 1 |
49
10.6%
|
| Global assessment score = 2 |
31
6.7%
|
| Global assessment score = 3 |
16
3.5%
|
| Global assessment score = 4 |
7
1.5%
|
| Global assessment score = 0 |
226
48.9%
|
| Global assessment score = 1 |
44
9.5%
|
| Global assessment score = 2 |
27
5.8%
|
| Global assessment score = 3 |
10
2.2%
|
| Global assessment score = 4 |
7
1.5%
|
| Global assessment score = 0 |
220
47.6%
|
| Global assessment score = 1 |
40
8.7%
|
| Global assessment score = 2 |
21
4.5%
|
| Global assessment score = 3 |
7
1.5%
|
| Global assessment score = 4 |
4
0.9%
|
| Global assessment score = 0 |
188
40.7%
|
| Global assessment score = 1 |
28
6.1%
|
| Global assessment score = 2 |
19
4.1%
|
| Global assessment score = 3 |
2
0.4%
|
| Global assessment score = 4 |
2
0.4%
|
| Global assessment score = 0 |
172
37.2%
|
| Global assessment score = 1 |
26
5.6%
|
| Global assessment score = 2 |
15
3.2%
|
| Global assessment score = 3 |
6
1.3%
|
| Global assessment score = 4 |
1
0.2%
|
| Global assessment score = 0 |
138
29.9%
|
| Global assessment score = 1 |
20
4.3%
|
| Global assessment score = 2 |
13
2.8%
|
| Global assessment score = 3 |
5
1.1%
|
| Global assessment score = 4 |
1
0.2%
|
| Global assessment score = 0 |
143
31%
|
| Global assessment score = 1 |
17
3.7%
|
| Global assessment score = 2 |
10
2.2%
|
| Global assessment score = 3 |
3
0.6%
|
| Global assessment score = 4 |
0
0%
|
| Global assessment score = 0 |
36
7.8%
|
| Global assessment score = 1 |
11
2.4%
|
| Global assessment score = 2 |
1
0.2%
|
| Global assessment score = 3 |
1
0.2%
|
| Global assessment score = 4 |
1
0.2%
|
| Global assessment score = 0 |
37
8%
|
| Global assessment score = 1 |
7
1.5%
|
| Global assessment score = 2 |
4
0.9%
|
| Global assessment score = 3 |
1
0.2%
|
| Global assessment score = 4 |
0
0%
|
| Title | Number of Participants With Cardinal Symptoms of Behcet's Disease |
|---|---|
| Description | The presence or absence of symptoms including recurrent aphthous ulcers of oral mucosa, cutaneous symptoms, eye symptoms and ulceration of vulva was assessed at weeks 52, 104 and 156 against presence or absence at baseline. |
| Time Frame | Up to Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. |
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Measure Participants | 220 |
| Assessment absence and baseline absence |
99
21.4%
|
| Assessment absence and baseline presence |
84
18.2%
|
| Assessment presence and baseline absence |
7
1.5%
|
| Assessment presence and baseline presence |
29
6.3%
|
| Assessment absence and baseline absence |
74
16%
|
| Assessment absence and baseline presence |
59
12.8%
|
| Assessment presence and baseline absence |
13
2.8%
|
| Assessment presence and baseline presence |
26
5.6%
|
| Assessment absence and baseline absence |
27
5.8%
|
| Assessment absence and baseline presence |
12
2.6%
|
| Assessment presence and baseline absence |
5
1.1%
|
| Assessment presence and baseline presence |
5
1.1%
|
| Assessment absence and baseline absence |
147
31.8%
|
| Assessment absence and baseline presence |
56
12.1%
|
| Assessment presence and baseline absence |
5
1.1%
|
| Assessment presence and baseline presence |
11
2.4%
|
| Assessment absence and baseline absence |
123
26.6%
|
| Assessment absence and baseline presence |
34
7.4%
|
| Assessment presence and baseline absence |
7
1.5%
|
| Assessment presence and baseline presence |
9
1.9%
|
| Assessment absence and baseline absence |
32
6.9%
|
| Assessment absence and baseline presence |
13
2.8%
|
| Assessment presence and baseline absence |
4
0.9%
|
| Assessment presence and baseline presence |
0
0%
|
| Assessment absence and baseline absence |
216
46.8%
|
| Assessment absence and baseline presence |
3
0.6%
|
| Assessment presence and baseline absence |
0
0%
|
| Assessment presence and baseline presence |
1
0.2%
|
| Assessment absence and baseline absence |
168
36.4%
|
| Assessment absence and baseline presence |
4
0.9%
|
| Assessment presence and baseline absence |
1
0.2%
|
| Assessment presence and baseline presence |
0
0%
|
| Assessment absence and baseline absence |
48
10.4%
|
| Assessment absence and baseline presence |
1
0.2%
|
| Assessment presence and baseline absence |
0
0%
|
| Assessment presence and baseline presence |
0
0%
|
| Assessment absence and baseline absence |
184
39.8%
|
| Assessment absence and baseline presence |
27
5.8%
|
| Assessment presence and baseline absence |
1
0.2%
|
| Assessment presence and baseline presence |
8
1.7%
|
| Assessment absence and baseline absence |
151
32.7%
|
| Assessment absence and baseline presence |
14
3%
|
| Assessment presence and baseline absence |
4
0.9%
|
| Assessment presence and baseline presence |
4
0.9%
|
| Assessment absence and baseline absence |
42
9.1%
|
| Assessment absence and baseline presence |
5
1.1%
|
| Assessment presence and baseline absence |
1
0.2%
|
| Assessment presence and baseline presence |
1
0.2%
|
| Title | Number of Participants With Accessory Symptoms of Behcet's Disease |
|---|---|
| Description | The presence or absence of symptoms including arthritis without deformity or stiffness, epididymitis, vascular lesions and moderate to severe central nervous system (CNS) lesions was assessed at weeks 52, 104 and 156 against presence or absence at baseline. |
| Time Frame | Up to Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. |
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Measure Participants | 221 |
| Assessment absence and baseline absence |
150
32.5%
|
| Assessment absence and baseline presence |
39
8.4%
|
| Assessment presence and baseline absence |
11
2.4%
|
| Assessment presence and baseline presence |
21
4.5%
|
| Assessment absence and baseline absence |
115
24.9%
|
| Assessment absence and baseline presence |
36
7.8%
|
| Assessment presence and baseline absence |
14
3%
|
| Assessment presence and baseline presence |
9
1.9%
|
| Assessment absence and baseline absence |
30
6.5%
|
| Assessment absence and baseline presence |
14
3%
|
| Assessment presence and baseline absence |
5
1.1%
|
| Assessment presence and baseline presence |
0
0%
|
| Assessment absence and baseline absence |
219
47.4%
|
| Assessment absence and baseline presence |
0
0%
|
| Assessment presence and baseline absence |
0
0%
|
| Assessment presence and baseline presence |
2
0.4%
|
| Assessment absence and baseline absence |
172
37.2%
|
| Assessment absence and baseline presence |
2
0.4%
|
| Assessment presence and baseline absence |
0
0%
|
| Assessment presence and baseline presence |
0
0%
|
| Assessment absence and baseline absence |
46
10%
|
| Assessment absence and baseline presence |
1
0.2%
|
| Assessment presence and baseline absence |
1
0.2%
|
| Assessment presence and baseline presence |
1
0.2%
|
| Assessment absence and baseline absence |
213
46.1%
|
| Assessment absence and baseline presence |
0
0%
|
| Assessment presence and baseline absence |
1
0.2%
|
| Assessment presence and baseline presence |
7
1.5%
|
| Assessment absence and baseline absence |
168
36.4%
|
| Assessment absence and baseline presence |
4
0.9%
|
| Assessment presence and baseline absence |
0
0%
|
| Assessment presence and baseline presence |
2
0.4%
|
| Assessment absence and baseline absence |
47
10.2%
|
| Assessment absence and baseline presence |
1
0.2%
|
| Assessment presence and baseline absence |
1
0.2%
|
| Assessment presence and baseline presence |
0
0%
|
| Assessment absence and baseline absence |
217
47%
|
| Assessment absence and baseline presence |
1
0.2%
|
| Assessment presence and baseline absence |
1
0.2%
|
| Assessment presence and baseline presence |
2
0.4%
|
| Assessment absence and baseline absence |
171
37%
|
| Assessment absence and baseline presence |
1
0.2%
|
| Assessment presence and baseline absence |
0
0%
|
| Assessment presence and baseline presence |
2
0.4%
|
| Assessment absence and baseline absence |
48
10.4%
|
| Assessment absence and baseline presence |
0
0%
|
| Assessment presence and baseline absence |
1
0.2%
|
| Assessment presence and baseline presence |
0
0%
|
| Title | Number of Participants With Degree of Improvement of Endoscopic Findings |
|---|---|
| Description | The number of participants with improvement in endoscopic findings is assessed. |
| Time Frame | Up to Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. |
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Measure Participants | 383 |
| Cured or scarring |
64
13.9%
|
| Diminished in size |
38
8.2%
|
| Unchanged |
24
5.2%
|
| Aggravated |
9
1.9%
|
| Unassessable |
2
0.4%
|
| Cured or scarring |
73
15.8%
|
| Diminished in size |
29
6.3%
|
| Unchanged |
12
2.6%
|
| Aggravated |
6
1.3%
|
| Unassessable |
8
1.7%
|
| Cured or scarring |
42
9.1%
|
| Diminished in size |
6
1.3%
|
| Unchanged |
9
1.9%
|
| Aggravated |
0
0%
|
| Unassessable |
3
0.6%
|
| Cured or scarring |
29
6.3%
|
| Diminished in size |
6
1.3%
|
| Unchanged |
7
1.5%
|
| Aggravated |
5
1.1%
|
| Unassessable |
2
0.4%
|
| Cured or scarring |
16
3.5%
|
| Diminished in size |
3
0.6%
|
| Unchanged |
1
0.2%
|
| Aggravated |
1
0.2%
|
| Unassessable |
1
0.2%
|
| Cured or scarring |
9
1.9%
|
| Diminished in size |
1
0.2%
|
| Unchanged |
0
0%
|
| Aggravated |
0
0%
|
| Unassessable |
1
0.2%
|
| Title | Changes in C-reactive Protein (CRP) |
|---|---|
| Description | The change in CRP from baseline through the end of the study was assessed. |
| Time Frame | Up to Week 156 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy. |
| Arm/Group Title | Participants Who Received Humira® |
|---|---|
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration |
| Measure Participants | 383 |
| Baseline |
2.0239
(3.4242)
|
| Week 24 |
0.5389
(1.5150)
|
| Week 52 |
0.5504
(1.4651)
|
| Week 76 |
0.3348
(0.8126)
|
| Week 104 |
0.4031
(1.1279)
|
| Week 128 |
0.5034
(2.5356)
|
| Week 156 |
0.2246
(0.5808)
|
Adverse Events
| Time Frame | Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks). | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Participants Who Received Humira® | |
| Arm/Group Description | Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration | |
All Cause Mortality |
||
| Participants Who Received Humira® | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/462 (0.9%) | |
Serious Adverse Events |
||
| Participants Who Received Humira® | ||
| Affected / at Risk (%) | # Events | |
| Total | 75/462 (16.2%) | |
| Blood and lymphatic system disorders | ||
| ANAEMIA MEGALOBLASTIC | 1/462 (0.2%) | 1 |
| PANCYTOPENIA | 1/462 (0.2%) | 1 |
| BONE MARROW FAILURE | 1/462 (0.2%) | 1 |
| Endocrine disorders | ||
| ADRENAL DISORDER | 1/462 (0.2%) | 1 |
| DIABETES INSIPIDUS | 1/462 (0.2%) | 1 |
| THYROIDITIS SUBACUTE | 1/462 (0.2%) | 1 |
| Gastrointestinal disorders | ||
| ABDOMINAL PAIN | 1/462 (0.2%) | 1 |
| ENTEROCOLITIS | 1/462 (0.2%) | 1 |
| GASTROINTESTINAL HAEMORRHAGE | 1/462 (0.2%) | 1 |
| ILEAL PERFORATION | 2/462 (0.4%) | 2 |
| ILEAL ULCER | 2/462 (0.4%) | 2 |
| ILEUS | 2/462 (0.4%) | 2 |
| INTESTINAL PERFORATION | 3/462 (0.6%) | 3 |
| LARGE INTESTINE PERFORATION | 2/462 (0.4%) | 2 |
| PANCREATITIS | 1/462 (0.2%) | 1 |
| SMALL INTESTINAL PERFORATION | 1/462 (0.2%) | 1 |
| STOMATITIS | 1/462 (0.2%) | 1 |
| LOWER GASTROINTESTINAL HAEMORRHAGE | 1/462 (0.2%) | 1 |
| SMALL INTESTINAL HAEMORRHAGE | 1/462 (0.2%) | 1 |
| FISTULA OF SMALL INTESTINE | 1/462 (0.2%) | 1 |
| DENTAL CYST | 1/462 (0.2%) | 1 |
| General disorders | ||
| PYREXIA | 7/462 (1.5%) | 7 |
| Hepatobiliary disorders | ||
| BILE DUCT STONE | 1/462 (0.2%) | 1 |
| CHOLECYSTITIS | 2/462 (0.4%) | 2 |
| CHOLECYSTITIS ACUTE | 1/462 (0.2%) | 1 |
| Infections and infestations | ||
| BRONCHITIS | 1/462 (0.2%) | 1 |
| BRONCHOPULMONARY ASPERGILLOSIS | 1/462 (0.2%) | 1 |
| CAMPYLOBACTER GASTROENTERITIS | 1/462 (0.2%) | 1 |
| MENINGITIS LISTERIA | 1/462 (0.2%) | 1 |
| PERIODONTITIS | 1/462 (0.2%) | 1 |
| PHARYNGITIS | 1/462 (0.2%) | 1 |
| PNEUMONIA | 5/462 (1.1%) | 5 |
| PSEUDOMEMBRANOUS COLITIS | 1/462 (0.2%) | 1 |
| PULMONARY TUBERCULOSIS | 1/462 (0.2%) | 1 |
| SEPSIS | 3/462 (0.6%) | 3 |
| ANAL ABSCESS | 1/462 (0.2%) | 1 |
| INTERVERTEBRAL DISCITIS | 1/462 (0.2%) | 1 |
| ABDOMINAL ABSCESS | 1/462 (0.2%) | 1 |
| PNEUMONIA BACTERIAL | 1/462 (0.2%) | 1 |
| COLONIC ABSCESS | 1/462 (0.2%) | 1 |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | 2/462 (0.4%) | 2 |
| VARICELLA ZOSTER VIRUS INFECTION | 1/462 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||
| PELVIC FRACTURE | 1/462 (0.2%) | 1 |
| Investigations | ||
| C-REACTIVE PROTEIN INCREASED | 2/462 (0.4%) | 2 |
| PLATELET COUNT DECREASED | 1/462 (0.2%) | 1 |
| WHITE BLOOD CELL COUNT DECREASED | 2/462 (0.4%) | 2 |
| WHITE BLOOD CELL COUNT INCREASED | 1/462 (0.2%) | 1 |
| HEPATIC ENZYME INCREASED | 1/462 (0.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| FISTULA | 1/462 (0.2%) | 1 |
| LUPUS-LIKE SYNDROME | 1/462 (0.2%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| BREAST CANCER | 1/462 (0.2%) | 1 |
| CHRONIC MYELOMONOCYTIC LEUKAEMIA | 1/462 (0.2%) | 1 |
| MYELODYSPLASTIC SYNDROME | 1/462 (0.2%) | 1 |
| GASTROINTESTINAL STROMAL TUMOUR | 1/462 (0.2%) | 1 |
| MYELODYSPLASTIC SYNDROME TRANSFORMATION | 1/462 (0.2%) | 1 |
| EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER | 1/462 (0.2%) | 1 |
| Nervous system disorders | ||
| CEREBRAL HAEMORRHAGE | 1/462 (0.2%) | 1 |
| CEREBRAL INFARCTION | 1/462 (0.2%) | 1 |
| NEUROPATHY PERIPHERAL | 1/462 (0.2%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||
| ABORTION MISSED | 1/462 (0.2%) | 1 |
| Psychiatric disorders | ||
| COMPLETED SUICIDE | 1/462 (0.2%) | 1 |
| Renal and urinary disorders | ||
| ACUTE KIDNEY INJURY | 1/462 (0.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| INTERSTITIAL LUNG DISEASE | 1/462 (0.2%) | 1 |
| PLEURAL EFFUSION | 1/462 (0.2%) | 1 |
| PNEUMONIA ASPIRATION | 2/462 (0.4%) | 2 |
| RESPIRATORY FAILURE | 1/462 (0.2%) | 1 |
| Vascular disorders | ||
| BEHCET'S SYNDROME | 11/462 (2.4%) | 11 |
| SHOCK HAEMORRHAGIC | 1/462 (0.2%) | 1 |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 1/462 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Participants Who Received Humira® | ||
| Affected / at Risk (%) | # Events | |
| Total | 165/462 (35.7%) | |
| Blood and lymphatic system disorders | ||
| ANAEMIA | 3/462 (0.6%) | 3 |
| ANAEMIA MEGALOBLASTIC | 1/462 (0.2%) | 1 |
| FEBRILE NEUTROPENIA | 1/462 (0.2%) | 1 |
| IRON DEFICIENCY ANAEMIA | 1/462 (0.2%) | 1 |
| LYMPHADENITIS | 1/462 (0.2%) | 1 |
| PANCYTOPENIA | 1/462 (0.2%) | 1 |
| BONE MARROW FAILURE | 1/462 (0.2%) | 1 |
| Endocrine disorders | ||
| ADRENAL DISORDER | 1/462 (0.2%) | 1 |
| ADRENAL INSUFFICIENCY | 1/462 (0.2%) | 1 |
| DIABETES INSIPIDUS | 2/462 (0.4%) | 2 |
| THYROIDITIS SUBACUTE | 1/462 (0.2%) | 1 |
| Eye disorders | ||
| CONJUNCTIVITIS ALLERGIC | 1/462 (0.2%) | 1 |
| VITREOUS FLOATERS | 1/462 (0.2%) | 1 |
| Gastrointestinal disorders | ||
| ABDOMINAL PAIN | 2/462 (0.4%) | 2 |
| ABDOMINAL PAIN LOWER | 1/462 (0.2%) | 1 |
| ABDOMINAL PAIN UPPER | 1/462 (0.2%) | 1 |
| COLITIS | 1/462 (0.2%) | 1 |
| CONSTIPATION | 3/462 (0.6%) | 3 |
| DIARRHOEA | 2/462 (0.4%) | 2 |
| ENTEROCOLITIS | 2/462 (0.4%) | 2 |
| GASTRITIS ALCOHOLIC | 1/462 (0.2%) | 1 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 3/462 (0.6%) | 3 |
| GASTROINTESTINAL HAEMORRHAGE | 1/462 (0.2%) | 1 |
| HAEMATOCHEZIA | 1/462 (0.2%) | 1 |
| ILEAL PERFORATION | 2/462 (0.4%) | 2 |
| ILEAL ULCER | 2/462 (0.4%) | 2 |
| ILEUS | 2/462 (0.4%) | 2 |
| INTESTINAL PERFORATION | 3/462 (0.6%) | 3 |
| INTESTINAL STENOSIS | 1/462 (0.2%) | 1 |
| INTESTINAL ULCER | 1/462 (0.2%) | 1 |
| IRRITABLE BOWEL SYNDROME | 1/462 (0.2%) | 1 |
| LARGE INTESTINE PERFORATION | 2/462 (0.4%) | 2 |
| NAUSEA | 2/462 (0.4%) | 2 |
| PANCREATITIS | 1/462 (0.2%) | 1 |
| SMALL INTESTINAL PERFORATION | 1/462 (0.2%) | 1 |
| STOMATITIS | 5/462 (1.1%) | 5 |
| VOMITING | 3/462 (0.6%) | 3 |
| LOWER GASTROINTESTINAL HAEMORRHAGE | 1/462 (0.2%) | 1 |
| SMALL INTESTINAL HAEMORRHAGE | 1/462 (0.2%) | 1 |
| EPIGASTRIC DISCOMFORT | 1/462 (0.2%) | 1 |
| FISTULA OF SMALL INTESTINE | 1/462 (0.2%) | 1 |
| FAECES SOFT | 1/462 (0.2%) | 1 |
| DENTAL CYST | 1/462 (0.2%) | 1 |
| General disorders | ||
| ASTHENIA | 1/462 (0.2%) | 1 |
| INJECTION SITE ERYTHEMA | 1/462 (0.2%) | 1 |
| INJECTION SITE REACTION | 4/462 (0.9%) | 4 |
| MALAISE | 5/462 (1.1%) | 5 |
| PAIN | 1/462 (0.2%) | 1 |
| PYREXIA | 13/462 (2.8%) | 13 |
| Hepatobiliary disorders | ||
| ALCOHOLIC LIVER DISEASE | 1/462 (0.2%) | 1 |
| BILE DUCT STONE | 1/462 (0.2%) | 1 |
| CHOLECYSTITIS | 2/462 (0.4%) | 2 |
| CHOLECYSTITIS ACUTE | 1/462 (0.2%) | 1 |
| HEPATIC FUNCTION ABNORMAL | 2/462 (0.4%) | 2 |
| HEPATIC STEATOSIS | 1/462 (0.2%) | 1 |
| LIVER DISORDER | 1/462 (0.2%) | 1 |
| Immune system disorders | ||
| HYPOGAMMAGLOBULINAEMIA | 1/462 (0.2%) | 1 |
| SEASONAL ALLERGY | 1/462 (0.2%) | 1 |
| Infections and infestations | ||
| ANGULAR CHEILITIS | 1/462 (0.2%) | 1 |
| BRONCHITIS | 3/462 (0.6%) | 3 |
| BRONCHOPULMONARY ASPERGILLOSIS | 2/462 (0.4%) | 2 |
| CAMPYLOBACTER GASTROENTERITIS | 1/462 (0.2%) | 1 |
| CELLULITIS | 1/462 (0.2%) | 1 |
| CYSTITIS | 1/462 (0.2%) | 1 |
| GASTROENTERITIS | 2/462 (0.4%) | 2 |
| HERPES ZOSTER | 2/462 (0.4%) | 2 |
| INFLUENZA | 2/462 (0.4%) | 2 |
| MENINGITIS LISTERIA | 1/462 (0.2%) | 1 |
| NASOPHARYNGITIS | 10/462 (2.2%) | 10 |
| ORAL CANDIDIASIS | 2/462 (0.4%) | 2 |
| OTITIS MEDIA | 2/462 (0.4%) | 2 |
| OTITIS MEDIA CHRONIC | 1/462 (0.2%) | 1 |
| PERIODONTITIS | 1/462 (0.2%) | 1 |
| PHARYNGITIS | 1/462 (0.2%) | 1 |
| PNEUMONIA | 7/462 (1.5%) | 7 |
| PSEUDOMEMBRANOUS COLITIS | 1/462 (0.2%) | 1 |
| PULMONARY TUBERCULOSIS | 1/462 (0.2%) | 1 |
| PYELONEPHRITIS | 1/462 (0.2%) | 1 |
| SEPSIS | 3/462 (0.6%) | 3 |
| SINUSITIS | 1/462 (0.2%) | 1 |
| TINEA PEDIS | 1/462 (0.2%) | 1 |
| TONSILLITIS | 2/462 (0.4%) | 2 |
| UPPER RESPIRATORY TRACT INFECTION | 2/462 (0.4%) | 2 |
| VULVOVAGINAL CANDIDIASIS | 2/462 (0.4%) | 2 |
| ANAL ABSCESS | 3/462 (0.6%) | 3 |
| ENTERITIS INFECTIOUS | 1/462 (0.2%) | 1 |
| INTERVERTEBRAL DISCITIS | 1/462 (0.2%) | 1 |
| ABDOMINAL ABSCESS | 1/462 (0.2%) | 1 |
| PNEUMONIA BACTERIAL | 2/462 (0.4%) | 2 |
| LUNG INFECTION | 1/462 (0.2%) | 1 |
| ENTEROCOLITIS VIRAL | 1/462 (0.2%) | 1 |
| DEVICE RELATED INFECTION | 1/462 (0.2%) | 1 |
| LATENT TUBERCULOSIS | 2/462 (0.4%) | 2 |
| ORAL HERPES | 1/462 (0.2%) | 1 |
| COLONIC ABSCESS | 1/462 (0.2%) | 1 |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | 2/462 (0.4%) | 2 |
| VARICELLA ZOSTER VIRUS INFECTION | 1/462 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||
| FOOT FRACTURE | 2/462 (0.4%) | 2 |
| RIB FRACTURE | 1/462 (0.2%) | 1 |
| PELVIC FRACTURE | 1/462 (0.2%) | 1 |
| Investigations | ||
| ALANINE AMINOTRANSFERASE INCREASED | 1/462 (0.2%) | 1 |
| C-REACTIVE PROTEIN INCREASED | 12/462 (2.6%) | 12 |
| LIVER FUNCTION TEST ABNORMAL | 1/462 (0.2%) | 1 |
| PLATELET COUNT DECREASED | 2/462 (0.4%) | 2 |
| WHITE BLOOD CELL COUNT DECREASED | 5/462 (1.1%) | 5 |
| WHITE BLOOD CELL COUNT INCREASED | 2/462 (0.4%) | 2 |
| ANTITHROMBIN III DECREASED | 1/462 (0.2%) | 1 |
| BLOOD BETA-D-GLUCAN INCREASED | 2/462 (0.4%) | 2 |
| BRAIN NATRIURETIC PEPTIDE INCREASED | 1/462 (0.2%) | 1 |
| TRANSAMINASES INCREASED | 1/462 (0.2%) | 1 |
| COMPUTERISED TOMOGRAM THORAX ABNORMAL | 2/462 (0.4%) | 2 |
| HEPATIC ENZYME INCREASED | 1/462 (0.2%) | 1 |
| LIVER FUNCTION TEST INCREASED | 1/462 (0.2%) | 1 |
| Metabolism and nutrition disorders | ||
| HYPERURICAEMIA | 1/462 (0.2%) | 1 |
| DYSLIPIDAEMIA | 1/462 (0.2%) | 1 |
| DECREASED APPETITE | 2/462 (0.4%) | 2 |
| HYPERLIPIDAEMIA | 1/462 (0.2%) | 1 |
| HYPERAMYLASAEMIA | 1/462 (0.2%) | 1 |
| TYPE 2 DIABETES MELLITUS | 2/462 (0.4%) | 2 |
| HYPERLIPASAEMIA | 1/462 (0.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| ARTHRALGIA | 6/462 (1.3%) | 6 |
| ARTHRITIS | 2/462 (0.4%) | 2 |
| BACK PAIN | 1/462 (0.2%) | 1 |
| FISTULA | 1/462 (0.2%) | 1 |
| MUSCULAR WEAKNESS | 1/462 (0.2%) | 1 |
| OSTEOPOROSIS | 1/462 (0.2%) | 1 |
| PAIN IN EXTREMITY | 1/462 (0.2%) | 1 |
| LUPUS-LIKE SYNDROME | 1/462 (0.2%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| BREAST CANCER | 1/462 (0.2%) | 1 |
| CHRONIC MYELOMONOCYTIC LEUKAEMIA | 1/462 (0.2%) | 1 |
| MYELODYSPLASTIC SYNDROME | 1/462 (0.2%) | 1 |
| COLON ADENOMA | 1/462 (0.2%) | 1 |
| GASTROINTESTINAL STROMAL TUMOUR | 1/462 (0.2%) | 1 |
| MYELODYSPLASTIC SYNDROME TRANSFORMATION | 1/462 (0.2%) | 1 |
| EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER | 1/462 (0.2%) | 1 |
| Nervous system disorders | ||
| CEREBRAL HAEMORRHAGE | 1/462 (0.2%) | 1 |
| CEREBRAL INFARCTION | 1/462 (0.2%) | 1 |
| DYSGEUSIA | 1/462 (0.2%) | 1 |
| DYSLALIA | 1/462 (0.2%) | 1 |
| HEADACHE | 4/462 (0.9%) | 4 |
| HYPOAESTHESIA | 1/462 (0.2%) | 1 |
| NEUROPATHY PERIPHERAL | 1/462 (0.2%) | 1 |
| PRESYNCOPE | 1/462 (0.2%) | 1 |
| TREMOR | 1/462 (0.2%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||
| ABORTION MISSED | 1/462 (0.2%) | 1 |
| Psychiatric disorders | ||
| COMPLETED SUICIDE | 1/462 (0.2%) | 1 |
| INSOMNIA | 3/462 (0.6%) | 3 |
| OBSESSIVE-COMPULSIVE DISORDER | 1/462 (0.2%) | 1 |
| DEPRESSIVE SYMPTOM | 1/462 (0.2%) | 1 |
| Renal and urinary disorders | ||
| ACUTE KIDNEY INJURY | 1/462 (0.2%) | 1 |
| Reproductive system and breast disorders | ||
| BENIGN PROSTATIC HYPERPLASIA | 1/462 (0.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| ASTHMA | 1/462 (0.2%) | 1 |
| COUGH | 1/462 (0.2%) | 1 |
| DYSPNOEA | 1/462 (0.2%) | 1 |
| INTERSTITIAL LUNG DISEASE | 2/462 (0.4%) | 2 |
| PHARYNGEAL ULCERATION | 1/462 (0.2%) | 1 |
| PLEURAL EFFUSION | 1/462 (0.2%) | 1 |
| PNEUMONIA ASPIRATION | 2/462 (0.4%) | 2 |
| RESPIRATORY FAILURE | 1/462 (0.2%) | 1 |
| UPPER RESPIRATORY TRACT INFLAMMATION | 4/462 (0.9%) | 4 |
| PULMONARY MASS | 1/462 (0.2%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| DERMAL CYST | 1/462 (0.2%) | 1 |
| DYSHIDROTIC ECZEMA | 1/462 (0.2%) | 1 |
| ERYTHEMA NODOSUM | 1/462 (0.2%) | 1 |
| HAEMORRHAGE SUBCUTANEOUS | 1/462 (0.2%) | 1 |
| PRURIGO | 1/462 (0.2%) | 1 |
| URTICARIA | 2/462 (0.4%) | 2 |
| GENERALISED ERYTHEMA | 1/462 (0.2%) | 1 |
| DERMATITIS PSORIASIFORM | 1/462 (0.2%) | 1 |
| Vascular disorders | ||
| ARTERIOSCLEROSIS | 1/462 (0.2%) | 1 |
| BEHCET'S SYNDROME | 15/462 (3.2%) | 15 |
| HYPOTENSION | 1/462 (0.2%) | 1 |
| SHOCK HAEMORRHAGIC | 1/462 (0.2%) | 1 |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 1/462 (0.2%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT01960790
Other Study ID Numbers:
- P14-152
First Posted:
Oct 11, 2013
Last Update Posted:
Mar 22, 2019
Last Verified:
May 1, 2018