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: July 25, 2013
Last verified: July 2013

November 17, 2010
July 25, 2013
October 2010
March 2012   (final data collection date for primary outcome measure)
Number of Participants With Marked Improvement at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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).
Marked improvement rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Marked improvement rate is defined by combination of global assessment of gastrointestinal symptoms and endoscopic improvement. It is the proportion of the subjects whose global assessment of gastrointestinal symptoms and endoscopic improvement are both =< 1.
Complete list of historical versions of study NCT01243671 on ClinicalTrials.gov Archive Site
  • Number of Participants With Complete Remission at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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).
  • Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    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).
  • Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    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).
  • Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL.
  • Global assessment of gastrointestinal symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Study subjects will assess globally their gastrointestinal symptoms (BD symptoms other than gastrointestinal symptoms are excluded) during 2 weeks before assessment visit in 5 grades. Investigator will confirm the assessment through the interview to the subjects.
  • Endoscopic improvement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Endoscopic improvement will be assessed in 4 grades compared to the screening endoscopy based on the longest diameter of ileocecal largest open ulcer.
  • Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    IBDQ is the standard questionnaire to assess the Quality of Life (QOL) of patients with Inflammatory Bowel Disease (IBD). It is validated in various languages and provided by McMaster university.
  • Short Form-36 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    SF-36 is the standard questionnaire to assess the health related Quality of Life (QOL) of general patients. It is validated in various languages and provided by iHope international.
Not Provided
Not Provided
 
A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
A Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease

To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Intestinal Behcet's Disease
Biological: Adalimumab
Other Name: ABT-D2E7, Humira
Experimental: 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.
Intervention: Biological: Adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2013
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Intestinal Behçet's disease
  • Patients with typical ulcer at ileocecal region
  • Patients who have failed conventional treatment

Exclusion Criteria:

  • Crohn's disease
  • History of ileocecal resection
  • History of tuberculosis (TB)
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01243671
M11-509
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Eisai Co., Ltd.
Study Director: Morio Ozawa, MS AbbVie GK
AbbVie
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP