Trial Outcomes & Findings for A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease (NCT NCT01243671)
NCT ID: NCT01243671
Last Updated: 2014-07-25
Results Overview
Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to \<2 cm, ≥2 cm to \<3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
24 weeks
Results posted on
2014-07-25
Participant Flow
Participant milestones
| Measure |
Adalimumab
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
Completed 24 Weeks of Treatment
|
18
|
|
Overall Study
Completed 52 Weeks of Treatment
|
17
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Adalimumab
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Anti-adalimumab antibody positive
|
1
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
Baseline characteristics by cohort
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
|
Age, Customized
<40 years
|
11 participants
n=5 Participants
|
|
Age, Customized
Between 40 and 65 years
|
7 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Longest Diameter of Ileocecal Largest Open Ulcer
>=1 cm to <2 cm
|
8 participants
n=5 Participants
|
|
Longest Diameter of Ileocecal Largest Open Ulcer
>=2 cm to <3 cm
|
5 participants
n=5 Participants
|
|
Longest Diameter of Ileocecal Largest Open Ulcer
>=3 cm
|
7 participants
n=5 Participants
|
|
Global Assessment of Gastrointestinal (GI) Symptoms Grade
Grade 0
|
0 participants
n=5 Participants
|
|
Global Assessment of Gastrointestinal (GI) Symptoms Grade
Grade 1
|
0 participants
n=5 Participants
|
|
Global Assessment of Gastrointestinal (GI) Symptoms Grade
Grade 2
|
0 participants
n=5 Participants
|
|
Global Assessment of Gastrointestinal (GI) Symptoms Grade
Grade 3
|
15 participants
n=5 Participants
|
|
Global Assessment of Gastrointestinal (GI) Symptoms Grade
Grade 4
|
5 participants
n=5 Participants
|
|
Assessment of Abdominal Pain (GI Symptom Component) Grade
Grade 0
|
2 participants
n=5 Participants
|
|
Assessment of Abdominal Pain (GI Symptom Component) Grade
Grade 1
|
1 participants
n=5 Participants
|
|
Assessment of Abdominal Pain (GI Symptom Component) Grade
Grade 2
|
3 participants
n=5 Participants
|
|
Assessment of Abdominal Pain (GI Symptom Component) Grade
Grade 3
|
10 participants
n=5 Participants
|
|
Assessment of Abdominal Pain (GI Symptom Component) Grade
Grade 4
|
4 participants
n=5 Participants
|
|
Assessment of Diarrhea (GI Symptom Component) Grade
Grade 0
|
4 participants
n=5 Participants
|
|
Assessment of Diarrhea (GI Symptom Component) Grade
Grade 1
|
6 participants
n=5 Participants
|
|
Assessment of Diarrhea (GI Symptom Component) Grade
Grade 2
|
0 participants
n=5 Participants
|
|
Assessment of Diarrhea (GI Symptom Component) Grade
Grade 3
|
9 participants
n=5 Participants
|
|
Assessment of Diarrhea (GI Symptom Component) Grade
Grade 4
|
1 participants
n=5 Participants
|
|
Assessment of Other Symptoms (GI Symptom Component) Grade
Grade 0
|
0 participants
n=5 Participants
|
|
Assessment of Other Symptoms (GI Symptom Component) Grade
Grade 1
|
1 participants
n=5 Participants
|
|
Assessment of Other Symptoms (GI Symptom Component) Grade
Grade 2
|
4 participants
n=5 Participants
|
|
Assessment of Other Symptoms (GI Symptom Component) Grade
Grade 3
|
12 participants
n=5 Participants
|
|
Assessment of Other Symptoms (GI Symptom Component) Grade
Grade 4
|
3 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Oral Aphthous Grade 0
|
5 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Oral Aphthous Grade 1
|
8 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Oral Aphthous Grade 2
|
3 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Oral Aphthous Grade 3
|
4 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Skin (Erythema Nodosum Rash) Grade 0
|
12 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Skin (Erythema Nodosum Rash) Grade 1
|
4 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Skin (Erythema Nodosum Rash) Grade 2
|
1 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Skin (Erythema Nodosum Rash) Grade 3
|
3 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Eye (Uveitis) Grade 0
|
20 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Eye (Uveitis) Grade 1
|
0 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Eye (Uveitis) Grade 2
|
0 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Eye (Uveitis) Grade 3
|
0 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Vulval (Genital) Ulcer Grade 0
|
17 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Vulval (Genital) Ulcer Grade 1
|
1 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Vulval (Genital) Ulcer Grade 2
|
0 participants
n=5 Participants
|
|
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade
Vulval (Genital) Ulcer Grade 3
|
2 participants
n=5 Participants
|
|
Inflammatory Bowel Disease Questionnaire (IBDQ)
|
140.5 units on a scale
STANDARD_DEVIATION 36.18 • n=5 Participants
|
|
Short-Form-36 (SF-36) Summary Scores
Physical Component Summary
|
41.8 units on a scale
STANDARD_DEVIATION 5.70 • n=5 Participants
|
|
Short-Form-36 (SF-36) Summary Scores
Mental Component Summary
|
34.6 units on a scale
STANDARD_DEVIATION 12.43 • n=5 Participants
|
|
C-Reactive Protein (CRP)
|
0.8 mg/dL
STANDARD_DEVIATION 1.17 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to \<2 cm, ≥2 cm to \<3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Number of Participants With Marked Improvement at Week 24
|
9 participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to \<2 cm, ≥2 cm to \<3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Number of Participants With Marked Improvement at Week 52
|
12 participants
|
SECONDARY outcome
Timeframe: 24 weeks, 52 weeksPopulation: Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Complete remission was defined as both endoscopic improvement and global assessment of gastrointestinal symptoms grades of 0. Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to \<2 cm, ≥2 cm to \<3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). Global assessment of gastrointestinal symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life.
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Number of Participants With Complete Remission at Week 24 and Week 52
Week 24
|
4 participants
|
|
Number of Participants With Complete Remission at Week 24 and Week 52
Week 52
|
4 participants
|
SECONDARY outcome
Timeframe: 24 weeks, 52 weeksPopulation: Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Study participants completed a global assessment of their gastrointestinal symptoms (Behçet's disease symptoms other than gastrointestinal symptoms were excluded) during 2 weeks before assessment visit on a 5-grade scale. The investigator confirmed this assessment via interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Global assessment of grade 0 or ≤1 and improvement of ≥1 (from baseline) is presented.
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24: Grade 0
|
9 participants
|
|
Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24: Grade ≤1
|
13 participants
|
|
Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24: Improvement of ≥1 Grade
|
16 participants
|
|
Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52: Grade 0
|
9 participants
|
|
Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52: Grade ≤1
|
16 participants
|
|
Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52: Improvement of ≥1 Grade
|
18 participants
|
SECONDARY outcome
Timeframe: 24 weeks, 52 weeksPopulation: Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to \<2 cm, ≥2 cm to \<3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion).
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52
Week 24: Grade 0
|
9 participants
|
|
Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52
Week 24: Grade ≤1
|
12 participants
|
|
Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52
Week 24: Grade ≤2
|
15 participants
|
|
Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52
Week 52: Grade 0
|
11 participants
|
|
Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52
Week 52: Grade ≤1
|
13 participants
|
|
Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52
Week 52: Grade ≤2
|
15 participants
|
SECONDARY outcome
Timeframe: 24 weeks, 52 weeksPopulation: Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.
Participants assessed their abdominal pain, diarrhea and other gastrointestinal symptoms (abdominal discomfort, abdominal fullness, etc) during 2 weeks before assessment visit in 5 grades. Investigator confirmed the assessment through interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Improvement of ≥1 grade from baseline is also presented.
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24: Abdominal Pain Grade ≤1; n=18
|
11 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24: Diarrhea Grade ≤1; n=16
|
13 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24: Other GI Symptom Grade ≤1; n=20
|
16 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24:Abdominal Pain Improvement ≥1 Grade; n=18
|
14 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24: Diarrhea Improvement ≥1 Grade; n=16
|
11 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 24:Other GI Symptom Improvement ≥1 Grade;n=20
|
18 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52: Abdominal Pain Grade ≤1; n=18
|
14 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52: Diarrhea Grade ≤1; n=16
|
15 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52: Other GI Symptom Grade ≤1; n=20
|
16 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52:Abdominal Pain Improvement ≥1 Grade; n=18
|
16 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52: Diarrhea Improvement ≥1 Grade; n=16
|
13 participants
|
|
Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52
Week 52:Other GI Symptom Improvement ≥1 Grade;n=20
|
18 participants
|
SECONDARY outcome
Timeframe: 24 weeks, 52 weeksPopulation: Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.
Investigators assessed oral aphthous (mouth ulcers), skin symptoms, eye symptoms and vulval (genital) ulcers during 4 weeks before study visit via participant interview, using the following grades. Oral aphthous: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Skin (Erythema nodosum rash): 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Eye (Uveitis): 0=None; 1=one eye crisis in recent 4 weeks; 2=two eye crises in recent 4 weeks; 3=three eye crises in recent 4 weeks. Vulval (genital) ulcer: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Resolution was defined as: Behçet's disease symptoms other than gastrointestinal symptoms were graded 0 (disappeared).
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Week 24: Oral Aphthous; n=15
|
10 participants
|
|
Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Week 24: Skin (Erythema nodosum rash); n=8
|
6 participants
|
|
Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Week 24: Eye (Uveitis); n=0
|
0 participants
|
|
Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Week 24: Vulval (Genital) Ulcer; n=3
|
2 participants
|
|
Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Week 52: Oral Aphthous; n=15
|
10 participants
|
|
Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Week 52: Skin (Erythema nodosum rash); n=8
|
7 participants
|
|
Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Week 52: Eye (Uveitis); n=0
|
0 participants
|
|
Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Week 52: Vulval (Genital) Ulcer; n=3
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 52 weeksPopulation: Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.
Inflammatory Bowel Disease Questionnaire (IBDQ) is the standard questionnaire to assess the quality of life of patients with inflammatory bowel disease. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52
Week 24
|
37.1 units on a scale
Standard Deviation 40.00
|
|
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52
Week 52
|
41.2 units on a scale
Standard Deviation 41.91
|
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 52 weeksPopulation: Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.
The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). The mental component reflects vitality, social functioning, role-emotional and mental health. Score on the mental component ranges from 0 (poorest health) to 100 (best health).
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52
Week 24: Summary Score (Physical Component)
|
7.5 units on a scale
Standard Deviation 7.18
|
|
Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52
Week 24: Summary Score (Mental Component)
|
8.9 units on a scale
Standard Deviation 12.85
|
|
Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52
Week 52: Summary Score (Physical Component)
|
9.0 units on a scale
Standard Deviation 8.42
|
|
Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52
Week 52: Summary Score (Mental Component)
|
9.0 units on a scale
Standard Deviation 13.27
|
SECONDARY outcome
Timeframe: Baseline, 24 weeks, 52 weeksPopulation: Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.
C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.
Outcome measures
| Measure |
Adalimumab
n=20 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52
Week 24
|
-0.3 mg/dL
Standard Deviation 1.27 • Interval -3.0 to 3.0
|
|
Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52
Week 52
|
-0.2 mg/dL
Standard Deviation 2.22
|
Adverse Events
Adalimumab
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adalimumab
n=20 participants at risk
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Endocrine disorders
AUTOIMMUNE THYROIDITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
SUBILEUS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Immune system disorders
BEHCET'S SYNDROME
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
ABSCESS INTESTINAL
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
APPENDICITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Nervous system disorders
SPONDYLITIC MYELOPATHY
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
Other adverse events
| Measure |
Adalimumab
n=20 participants at risk
Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Congenital, familial and genetic disorders
SYRINGOMYELIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Eye disorders
BLEPHARITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Eye disorders
CHALAZION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Eye disorders
CONJUNCTIVITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Eye disorders
DRY EYE
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Eye disorders
OCULAR HYPERAEMIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Eye disorders
VISION BLURRED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Eye disorders
VITREOUS FLOATERS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
CHEILITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
15.0%
3/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
DIARRHOEA
|
15.0%
3/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
GASTRIC POLYPS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
NAUSEA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
ORAL DISORDER
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
PALATAL OEDEMA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
PROCTITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
SMALL INTESTINE ULCER
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
STOMATITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Gastrointestinal disorders
VOMITING
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
General disorders
FOREIGN BODY REACTION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
General disorders
GRANULOMA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
General disorders
INJECTION SITE REACTION
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Hepatobiliary disorders
LIVER DISORDER
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Immune system disorders
BEHCET'S SYNDROME
|
15.0%
3/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
ACUTE TONSILLITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
BACTERIAL INFECTION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
BRONCHITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
CAMPYLOBACTER INFECTION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
CYSTITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
ENTERITIS INFECTIOUS
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
FURUNCLE
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
GASTROENTERITIS
|
15.0%
3/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
GINGIVITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
HERPES ZOSTER
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
HORDEOLUM
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
INFLUENZA
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
NASOPHARYNGITIS
|
55.0%
11/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
ORAL HERPES
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
OTITIS MEDIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
PHARYNGITIS
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
TINEA INFECTION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
TINEA VERSICOLOUR
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
15.0%
3/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
ANTINUCLEAR ANTIBODY INCREASED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
CARCINOEMBRYONIC ANTIGEN INCREASED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Metabolism and nutrition disorders
OBESITY
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.0%
4/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Musculoskeletal and connective tissue disorders
PERIARTHRITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM OF THYROID GLAND
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON ADENOMA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOMA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Nervous system disorders
DIZZINESS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Nervous system disorders
HEADACHE
|
25.0%
5/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Nervous system disorders
HYPOAESTHESIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Nervous system disorders
LACUNAR INFARCTION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Psychiatric disorders
INSOMNIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Renal and urinary disorders
HYPERTONIC BLADDER
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Reproductive system and breast disorders
PROSTATIC CYST
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.0%
4/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
ECZEMA NUMMULAR
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
PAPULE
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
RASH
|
15.0%
3/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
SKIN MASS
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
10.0%
2/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
|
Vascular disorders
HYPERTENSION
|
5.0%
1/20 • Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
|
Additional Information
Global Medical Services
AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER