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A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease

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ClinicalTrials.gov Identifier: NCT01243671
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : May 15, 2013
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intestinal Behçet's Disease
Intervention Biological: Adalimumab
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adalimumab
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Completed 24 Weeks of Treatment 18
Completed 52 Weeks of Treatment 17
Completed 15 [1]
Not Completed 5
Reason Not Completed
Adverse Event             3
Anti-adalimumab antibody positive             1
Not Specified             1
[1]
Completed 136 weeks of treatment.
Arm/Group Title Adalimumab
Hide Arm/Group Description 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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
42.4  (13.33)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
<40 years 11
Between 40 and 65 years 7
>=65 years 2
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Longest Diameter of Ileocecal Largest Open Ulcer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
>=1 cm to <2 cm 8
>=2 cm to <3 cm 5
>=3 cm 7
[1]
Measure Description: Number of participants with longest diameter of ileocecal largest open ulcer in each of 3 categories, as determined by screening (baseline) endoscopy.
Global Assessment of Gastrointestinal (GI) Symptoms Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Grade 0 0
Grade 1 0
Grade 2 0
Grade 3 15
Grade 4 5
[1]
Measure Description: 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.
Assessment of Abdominal Pain (GI Symptom Component) Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Grade 0 2
Grade 1 1
Grade 2 3
Grade 3 10
Grade 4 4
[1]
Measure Description: Assessment of gastrointestinal symptom component of abdominal pain via a participant-assessed, investigator-confirmed grading of 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.
Assessment of Diarrhea (GI Symptom Component) Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Grade 0 4
Grade 1 6
Grade 2 0
Grade 3 9
Grade 4 1
[1]
Measure Description: Assessment of gastrointestinal symptom component of diarrhea via a participant-assessed, investigator-confirmed grading of 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.
Assessment of Other Symptoms (GI Symptom Component) Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Grade 0 0
Grade 1 1
Grade 2 4
Grade 3 12
Grade 4 3
[1]
Measure Description: Assessment of gastrointestinal symptoms other than abdominal pain or diarrhea (abdominal discomfort/fullness, etc) via a participant-assessed, investigator-confirmed grading of 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. Scores assess symptoms in the 2 weeks prior to Baseline.
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
Oral Aphthous Grade 0 5
Oral Aphthous Grade 1 8
Oral Aphthous Grade 2 3
Oral Aphthous Grade 3 4
Skin (Erythema Nodosum Rash) Grade 0 12
Skin (Erythema Nodosum Rash) Grade 1 4
Skin (Erythema Nodosum Rash) Grade 2 1
Skin (Erythema Nodosum Rash) Grade 3 3
Eye (Uveitis) Grade 0 20
Eye (Uveitis) Grade 1 0
Eye (Uveitis) Grade 2 0
Eye (Uveitis) Grade 3 0
Vulval (Genital) Ulcer Grade 0 17
Vulval (Genital) Ulcer Grade 1 1
Vulval (Genital) Ulcer Grade 2 0
Vulval (Genital) Ulcer Grade 3 2
[1]
Measure Description: Investigators assessed oral aphthous, skin symptoms (erythema nodosum rash), eye symptoms (uveitis) and vulval (genital) ulcers during 4 weeks before baseline visit via participant interview at baseline, using the following grades: 0=None; 1=Symptom existed less than 2 weeks, or 1 eye crisis in recent 4 weeks; 2=Symptom existed 2 weeks or more, or 2 eye crises in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks, or 3 eye crises in recent 4 weeks.
Inflammatory Bowel Disease Questionnaire (IBDQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
140.5  (36.18)
[1]
Measure Description: 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).
Short-Form-36 (SF-36) Summary Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
Physical Component Summary 41.8  (5.70)
Mental Component Summary 34.6  (12.43)
[1]
Measure Description: 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).
C-Reactive Protein (CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 20 participants
0.8  (1.17)
[1]
Measure Description: C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.
1.Primary Outcome
Title Number of Participants With Marked Improvement at Week 24
Hide Description 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).
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
9
2.Secondary Outcome
Title Number of Participants With Marked Improvement at Week 52
Hide Description 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).
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
12
3.Secondary Outcome
Title Number of Participants With Complete Remission at Week 24 and Week 52
Hide Description 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.
Time Frame 24 weeks, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Week 24 4
Week 52 4
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 24 weeks, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Week 24: Grade 0 9
Week 24: Grade ≤1 13
Week 24: Improvement of ≥1 Grade 16
Week 52: Grade 0 9
Week 52: Grade ≤1 16
Week 52: Improvement of ≥1 Grade 18
5.Secondary Outcome
Title Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52
Hide Description 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).
Time Frame 24 weeks, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). Those with missing evaluations were imputed as non-responders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Week 24: Grade 0 9
Week 24: Grade ≤1 12
Week 24: Grade ≤2 15
Week 52: Grade 0 11
Week 52: Grade ≤1 13
Week 52: Grade ≤2 15
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 24 weeks, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Week 24: Abdominal Pain Grade ≤1; n=18 11
Week 24: Diarrhea Grade ≤1; n=16 13
Week 24: Other GI Symptom Grade ≤1; n=20 16
Week 24:Abdominal Pain Improvement ≥1 Grade; n=18 14
Week 24: Diarrhea Improvement ≥1 Grade; n=16 11
Week 24:Other GI Symptom Improvement ≥1 Grade;n=20 18
Week 52: Abdominal Pain Grade ≤1; n=18 14
Week 52: Diarrhea Grade ≤1; n=16 15
Week 52: Other GI Symptom Grade ≤1; n=20 16
Week 52:Abdominal Pain Improvement ≥1 Grade; n=18 16
Week 52: Diarrhea Improvement ≥1 Grade; n=16 13
Week 52:Other GI Symptom Improvement ≥1 Grade;n=20 18
7.Secondary Outcome
Title Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52
Hide Description 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).
Time Frame 24 weeks, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Week 24: Oral Aphthous; n=15 10
Week 24: Skin (Erythema nodosum rash); n=8 6
Week 24: Eye (Uveitis); n=0 0
Week 24: Vulval (Genital) Ulcer; n=3 2
Week 52: Oral Aphthous; n=15 10
Week 52: Skin (Erythema nodosum rash); n=8 7
Week 52: Eye (Uveitis); n=0 0
Week 52: Vulval (Genital) Ulcer; n=3 2
8.Secondary Outcome
Title Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52
Hide Description 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).
Time Frame Baseline, 24 weeks, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24 37.1  (40.00)
Week 52 41.2  (41.91)
9.Secondary Outcome
Title Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52
Hide Description 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).
Time Frame Baseline, 24 weeks, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 24: Summary Score (Physical Component) 7.5  (7.18)
Week 24: Summary Score (Mental Component) 8.9  (12.85)
Week 52: Summary Score (Physical Component) 9.0  (8.42)
Week 52: Summary Score (Mental Component) 9.0  (13.27)
10.Secondary Outcome
Title Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52
Hide Description C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.
Time Frame Baseline, 24 weeks, 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward.
Arm/Group Title Adalimumab
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 24 -0.3  (1.27)
Week 52 -0.2  (2.22)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adalimumab
Hide Arm/Group Description 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.
All-Cause Mortality
Adalimumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adalimumab
Affected / at Risk (%)
Total   6/20 (30.00%) 
Endocrine disorders   
AUTOIMMUNE THYROIDITIS  1  1/20 (5.00%) 
Gastrointestinal disorders   
INTESTINAL OBSTRUCTION  1  1/20 (5.00%) 
LOWER GASTROINTESTINAL HAEMORRHAGE  1  1/20 (5.00%) 
SUBILEUS  1  1/20 (5.00%) 
Immune system disorders   
BEHCET'S SYNDROME  1  1/20 (5.00%) 
Infections and infestations   
ABSCESS INTESTINAL  1  1/20 (5.00%) 
APPENDICITIS  1  1/20 (5.00%) 
APPENDICITIS PERFORATED  1  1/20 (5.00%) 
Nervous system disorders   
SPONDYLITIC MYELOPATHY  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adalimumab
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
ANAEMIA  1  1/20 (5.00%) 
IRON DEFICIENCY ANAEMIA  1  1/20 (5.00%) 
Congenital, familial and genetic disorders   
SYRINGOMYELIA  1  1/20 (5.00%) 
Eye disorders   
BLEPHARITIS  1  1/20 (5.00%) 
CHALAZION  1  1/20 (5.00%) 
CONJUNCTIVITIS  1  1/20 (5.00%) 
DRY EYE  1  1/20 (5.00%) 
OCULAR HYPERAEMIA  1  1/20 (5.00%) 
VISION BLURRED  1  1/20 (5.00%) 
VITREOUS FLOATERS  1  1/20 (5.00%) 
Gastrointestinal disorders   
ABDOMINAL PAIN UPPER  1  1/20 (5.00%) 
CHEILITIS  1  1/20 (5.00%) 
CONSTIPATION  1  1/20 (5.00%) 
DENTAL CARIES  1  3/20 (15.00%) 
DIARRHOEA  1  3/20 (15.00%) 
ENTEROCOLITIS  1  1/20 (5.00%) 
GASTRIC POLYPS  1  1/20 (5.00%) 
HAEMORRHOIDS  1  2/20 (10.00%) 
IRRITABLE BOWEL SYNDROME  1  2/20 (10.00%) 
NAUSEA  1  1/20 (5.00%) 
ORAL DISORDER  1  1/20 (5.00%) 
PALATAL OEDEMA  1  1/20 (5.00%) 
PROCTITIS  1  1/20 (5.00%) 
SMALL INTESTINE ULCER  1  1/20 (5.00%) 
STOMATITIS  1  1/20 (5.00%) 
VOMITING  1  1/20 (5.00%) 
General disorders   
FOREIGN BODY REACTION  1  1/20 (5.00%) 
GRANULOMA  1  1/20 (5.00%) 
INJECTION SITE REACTION  1  2/20 (10.00%) 
Hepatobiliary disorders   
HEPATIC FUNCTION ABNORMAL  1  1/20 (5.00%) 
HEPATIC STEATOSIS  1  1/20 (5.00%) 
LIVER DISORDER  1  1/20 (5.00%) 
Immune system disorders   
BEHCET'S SYNDROME  1  3/20 (15.00%) 
Infections and infestations   
ACUTE TONSILLITIS  1  1/20 (5.00%) 
BACTERIAL INFECTION  1  1/20 (5.00%) 
BRONCHITIS  1  1/20 (5.00%) 
CAMPYLOBACTER INFECTION  1  1/20 (5.00%) 
CYSTITIS  1  1/20 (5.00%) 
ENTERITIS INFECTIOUS  1  2/20 (10.00%) 
FURUNCLE  1  1/20 (5.00%) 
GASTROENTERITIS  1  3/20 (15.00%) 
GASTROENTERITIS VIRAL  1  1/20 (5.00%) 
GINGIVITIS  1  1/20 (5.00%) 
HERPES ZOSTER  1  1/20 (5.00%) 
HORDEOLUM  1  2/20 (10.00%) 
INFLUENZA  1  2/20 (10.00%) 
NASOPHARYNGITIS  1  11/20 (55.00%) 
ORAL HERPES  1  2/20 (10.00%) 
OTITIS MEDIA  1  1/20 (5.00%) 
PHARYNGITIS  1  2/20 (10.00%) 
TINEA INFECTION  1  1/20 (5.00%) 
TINEA VERSICOLOUR  1  1/20 (5.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  2/20 (10.00%) 
Injury, poisoning and procedural complications   
ARTHROPOD STING  1  1/20 (5.00%) 
CONTUSION  1  3/20 (15.00%) 
LIGAMENT SPRAIN  1  1/20 (5.00%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED  1  1/20 (5.00%) 
ANTINUCLEAR ANTIBODY INCREASED  1  1/20 (5.00%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/20 (5.00%) 
BLOOD CHOLESTEROL INCREASED  1  1/20 (5.00%) 
BLOOD CREATINE PHOSPHOKINASE INCREASED  1  1/20 (5.00%) 
CARCINOEMBRYONIC ANTIGEN INCREASED  1  1/20 (5.00%) 
LIVER FUNCTION TEST ABNORMAL  1  1/20 (5.00%) 
MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE  1  1/20 (5.00%) 
WHITE BLOOD CELL COUNT DECREASED  1  1/20 (5.00%) 
Metabolism and nutrition disorders   
DIABETES MELLITUS  1  1/20 (5.00%) 
HYPERURICAEMIA  1  1/20 (5.00%) 
OBESITY  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  2/20 (10.00%) 
BACK PAIN  1  4/20 (20.00%) 
OSTEOARTHRITIS  1  1/20 (5.00%) 
PERIARTHRITIS  1  1/20 (5.00%) 
SPINAL OSTEOARTHRITIS  1  2/20 (10.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BENIGN NEOPLASM OF THYROID GLAND  1  1/20 (5.00%) 
COLON ADENOMA  1  1/20 (5.00%) 
LIPOMA  1  1/20 (5.00%) 
RECTAL ADENOMA  1  1/20 (5.00%) 
Nervous system disorders   
DIZZINESS  1  1/20 (5.00%) 
HEADACHE  1  5/20 (25.00%) 
HYPOAESTHESIA  1  1/20 (5.00%) 
LACUNAR INFARCTION  1  1/20 (5.00%) 
Psychiatric disorders   
AFFECTIVE DISORDER  1  1/20 (5.00%) 
INSOMNIA  1  1/20 (5.00%) 
Renal and urinary disorders   
HYPERTONIC BLADDER  1  1/20 (5.00%) 
Reproductive system and breast disorders   
DYSMENORRHOEA  1  1/20 (5.00%) 
PROSTATIC CYST  1  1/20 (5.00%) 
UTERINE POLYP  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
ASTHMA  1  1/20 (5.00%) 
COUGH  1  4/20 (20.00%) 
DYSPHONIA  1  1/20 (5.00%) 
NASAL CONGESTION  1  1/20 (5.00%) 
RHINITIS ALLERGIC  1  1/20 (5.00%) 
Skin and subcutaneous tissue disorders   
ACNE  1  2/20 (10.00%) 
DERMATITIS  1  1/20 (5.00%) 
DRY SKIN  1  1/20 (5.00%) 
ECZEMA  1  2/20 (10.00%) 
ECZEMA NUMMULAR  1  1/20 (5.00%) 
PAPULE  1  1/20 (5.00%) 
RASH  1  3/20 (15.00%) 
RASH ERYTHEMATOUS  1  1/20 (5.00%) 
SKIN MASS  1  1/20 (5.00%) 
URTICARIA  1  2/20 (10.00%) 
Vascular disorders   
HYPERTENSION  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01243671     History of Changes
Other Study ID Numbers: M11-509
First Submitted: November 17, 2010
First Posted: November 18, 2010
Results First Submitted: March 26, 2013
Results First Posted: May 15, 2013
Last Update Posted: July 25, 2014