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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Eisai Co., Ltd.

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT01243671

First received: November 17, 2010

Last updated: March 26, 2013

Last verified: March 2013

History of Changes

Results First Received: March 26, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Intestinal Behcet's Disease
Intervention:	Biological: Adalimumab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Adalimumab
STARTED	20 ^[1]
COMPLETED	18 ^[2]
NOT COMPLETED	2
Adverse Event	2

[1]	Treated with study drug
[2]	Completed 24 weeks of treatment

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Adalimumab
Number of Participants [units: participants]	20
Age [units: years] Mean ± Standard Deviation	42.4 ± 13.33
Age, Customized [units: participants]
<40 years	11
Between 40 and 65 years	7
>=65 years	2
Gender [units: participants]
Female	10
Male	10
Longest Diameter of Ileocecal Largest Open Ulcer ^[1] [units: participants]
>=1 cm to <2 cm	8
>=2 cm to <3 cm	5
>=3 cm	7
Global Assessment of Gastrointestinal (GI) Symptoms Grade ^[2] [units: participants]
Grade 0	0
Grade 1	0
Grade 2	0
Grade 3	15
Grade 4	5
Assessment of Abdominal Pain (GI Symptom Component) Grade ^[3] [units: participants]
Grade 0	2
Grade 1	1
Grade 2	3
Grade 3	10
Grade 4	4
Assessment of Diarrhea (GI Symptom Component) Grade ^[4] [units: participants]
Grade 0	4
Grade 1	6
Grade 2	0
Grade 3	9
Grade 4	1
Assessment of Other Symptoms (GI Symptom Component) Grade ^[5] [units: participants]
Grade 0	0
Grade 1	1
Grade 2	4
Grade 3	12
Grade 4	3
Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade ^[6] [units: 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
Inflammatory Bowel Disease Questionnaire (IBDQ) ^[7] [units: units on a scale] Mean ± Standard Deviation	140.5 ± 36.18
Short-Form-36 (SF-36) Summary Scores ^[8] [units: units on a scale] Mean ± Standard Deviation
Physical Component Summary	41.8 ± 5.70
Mental Component Summary	34.6 ± 12.43
C-Reactive Protein (CRP) ^[9] [units: mg/dL] Mean ± Standard Deviation	0.8 ± 1.17

[1]	Number of participants with longest diameter of ileocecal largest open ulcer in each of 3 categories, as determined by screening (baseline) endoscopy.
[2]	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.
[3]	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.
[4]	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.
[5]	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.
[6]	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.
[7]	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).
[8]	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).
[9]	C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.

Outcome Measures

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1. Primary:

Number of Participants With Marked Improvement at Week 24 [ Time Frame: 24 weeks ]

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2. Secondary:

Number of Participants With Complete Remission at Week 24 [ Time Frame: 24 weeks ]

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3. Secondary:

Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 [ Time Frame: 24 weeks ]

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4. Secondary:

Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 [ Time Frame: 24 weeks ]

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5. Secondary:

Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 [ Time Frame: 24 weeks ]

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6. Secondary:

Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 [ Time Frame: 24 weeks ]

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7. Secondary:

Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 [ Time Frame: Baseline, 24 weeks ]

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8. Secondary:

Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 [ Time Frame: Baseline, 24 weeks ]

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9. Secondary:

Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 [ Time Frame: Baseline, 24 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
phone: 800-633-9110

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01243671 History of Changes
Other Study ID Numbers:	M11-509
Study First Received:	November 17, 2010
Results First Received:	March 26, 2013
Last Updated:	March 26, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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