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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease

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

Detailed Summary:
Sponsor: AbbVie (prior sponsor, Abbott)

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

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).


Original Primary Outcome: Marked improvement rate [ Time Frame: 24 weeks ]

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.


Current Secondary Outcome:

  • Number of Participants With Marked Improvement at Week 52 [ Time Frame: 52 weeks ]
    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).
  • Number of Participants With Complete Remission at Week 24 and Week 52 [ Time Frame: 24 weeks, 52 weeks ]
    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 and Week 52 [ Time Frame: 24 weeks, 52 weeks ]
    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 and Week 52 [ Time Frame: 24 weeks, 52 weeks ]
    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 and Week 52 [ Time Frame: 24 weeks, 52 weeks ]
    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 and Week 52 [ Time Frame: 24 weeks, 52 weeks ]
    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 (Eryt

    Original Secondary Outcome:

    • Global assessment of gastrointestinal symptoms [ Time Frame: 24 weeks ]
      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 ]
      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 ]
      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 ]
      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.


    Information By: AbbVie

    Dates:
    Date Received: November 17, 2010
    Date Started: October 2010
    Date Completion:
    Last Updated: June 27, 2014
    Last Verified: June 2014