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 ]
Original Primary Outcome: Marked improvement rate [ Time Frame: 24 weeks ]
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
- Global assessment of gastrointestinal symptoms [ Time Frame: 24 weeks ]