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

This study has been completed.
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: June 27, 2014
Last verified: June 2014
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 Behçet'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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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. 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.

Participant Flow:   Overall Study
    Adalimumab  
STARTED     20  
Completed 24 Weeks of Treatment     18  
Completed 52 Weeks of Treatment     17  
COMPLETED     15 [1]
NOT COMPLETED     5  
Adverse Event                 3  
Anti-adalimumab antibody positive                 1  
Not Specified                 1  
[1] Completed 136 weeks of treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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. 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.

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 ]

2.  Secondary:   Number of Participants With Marked Improvement at Week 52   [ Time Frame: 52 weeks ]

3.  Secondary:   Number of Participants With Complete Remission at Week 24 and Week 52   [ Time Frame: 24 weeks, 52 weeks ]

4.  Secondary:   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   [ Time Frame: 24 weeks, 52 weeks ]

5.  Secondary:   Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52   [ Time Frame: 24 weeks, 52 weeks ]

6.  Secondary:   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   [ Time Frame: 24 weeks, 52 weeks ]

7.  Secondary:   Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52   [ Time Frame: 24 weeks, 52 weeks ]

8.  Secondary:   Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52   [ Time Frame: Baseline, 24 weeks, 52 weeks ]

9.  Secondary:   Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52   [ Time Frame: Baseline, 24 weeks, 52 weeks ]

10.  Secondary:   Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52   [ Time Frame: Baseline, 24 weeks, 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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:
unchecked 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.
unchecked 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.


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: June 27, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare