Intestinal Behçet's Disease Clinical Trial
Official title:
A Multi-Center Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
| Verified date | June 2014 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2013 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Site Reference ID/Investigator# 46738 | Chikushino | |
| Japan | Site Reference ID/Investigator# 46723 | Kurume | |
| Japan | Site Reference ID/Investigator# 46728 | Nagoya-shi | |
| Japan | Site Reference ID/Investigator# 46725 | Nishinomiya-shi | |
| Japan | Site Reference ID/Investigator# 46730 | Osaka-shi | |
| Japan | Site Reference ID/Investigator# 46722 | Sagamihara-shi | |
| Japan | Site Reference ID/Investigator# 46726 | Sakura | |
| Japan | Site Reference ID/Investigator# 59578 | Sapporo-shi | |
| Japan | Site Reference ID/Investigator# 46724 | Takatsuki-shi | |
| Japan | Site Reference ID/Investigator# 46729 | Tokyo | |
| Japan | Site Reference ID/Investigator# 46737 | Tokyo | |
| Japan | Site Reference ID/Investigator# 46733 | Yokohama-shi |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) | Eisai Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Marked Improvement at Week 24 | 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). | 24 weeks | No |
| Secondary | Number of Participants With Marked Improvement at Week 52 | 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). | 52 weeks | No |
| Secondary | Number of Participants With Complete Remission at Week 24 and Week 52 | 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. | 24 weeks, 52 weeks | No |
| 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 | 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. | 24 weeks, 52 weeks | No |
| Secondary | Number of Participants With Endoscopic Improvement Grades 0, =1 and =2 at Week 24 and Week 52 | 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). | 24 weeks, 52 weeks | No |
| 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 | 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. | 24 weeks, 52 weeks | No |
| Secondary | Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52 | 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). | 24 weeks, 52 weeks | No |
| Secondary | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52 | 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). | Baseline, 24 weeks, 52 weeks | No |
| Secondary | Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52 | 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). | Baseline, 24 weeks, 52 weeks | No |
| Secondary | Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52 | C-Reactive Protein (CRP) normal range was defined as =0.3 mg/dL. | Baseline, 24 weeks, 52 weeks | No |