Trial record 5 of 44 for:    Behcet's Disease

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
  Purpose

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


Condition Intervention Phase
Intestinal Behcet's Disease
Biological: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Adalimumab
Other Name: ABT-D2E7, Humira

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243671

Locations
Japan
Site Reference ID/Investigator# 46738
Chikushino, Japan
Site Reference ID/Investigator# 59578
Hokkaido, Japan
Site Reference ID/Investigator# 46723
Kurume, Japan
Site Reference ID/Investigator# 46735
Kyoto, Japan
Site Reference ID/Investigator# 46728
Nagoya, Japan
Site Reference ID/Investigator# 46725
Nishinomiya, Japan
Site Reference ID/Investigator# 46730
Osaka, Japan
Site Reference ID/Investigator# 46722
Sagamihara, Japan
Site Reference ID/Investigator# 46726
Sakura, Japan
Site Reference ID/Investigator# 46724
Takatsuki, Japan
Site Reference ID/Investigator# 46729
Tokyo, Japan
Site Reference ID/Investigator# 46737
Tokyo, Japan
Site Reference ID/Investigator# 46736
Tokyo, Japan
Site Reference ID/Investigator# 46733
Yokohama, Japan
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Eisai Co., Ltd.
Investigators
Study Director: Morio Ozawa, MS AbbVie GK
  More Information

Additional Information:
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: July 25, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Behcet's, intestinal

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Vasculitis
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014