Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)

Study Overview
=================
Brief Summary
-----------------
This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease. Incidence and conditions of occurrence of adverse reactions in clinical practice Factors likely to affect the safety and effectiveness

Official Title
-----------------
Humira® 40mg Syringe 0.8mL Subcutaneous Injection Special Investigation in Patients With Intestinal Behcet's Disease

Conditions
-----------------
Behcet's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator) Exclusion Criteria: Contraindications according to the Package Insert include patients who had any of the following: serious infections tuberculosis a history of hypersensitivity to any ingredient of Humira® demyelinating disease or a history of demyelinating disease congestive cardiac failure
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants who received Humira®<br>Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions | The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed. | Up to Week 156 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Gastrointestinal Symptoms | Study participants completed a global assessment of their gastrointestinal symptoms on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life. | Up to Week 156 | 
| Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Study participants completed a global assessment of their gastrointestinal symptoms (including abdominal pain, diarrhea and other gastrointestinal symptoms such as abdominal distension, abdominal tenderness, and hemorrhage) on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life. | Up to Week 156 | 
| Number of Participants With Cardinal Symptoms of Behcet's Disease | The presence or absence of symptoms including recurrent aphthous ulcers of oral mucosa, cutaneous symptoms, eye symptoms and ulceration of vulva was assessed at weeks 52, 104 and 156 against presence or absence at baseline. | Up to Week 156 | 
| Number of Participants With Accessory Symptoms of Behcet's Disease | The presence or absence of symptoms including arthritis without deformity or stiffness, epididymitis, vascular lesions and moderate to severe central nervous system (CNS) lesions was assessed at weeks 52, 104 and 156 against presence or absence at baseline. | Up to Week 156 | 
| Number of Participants With Degree of Improvement of Endoscopic Findings | The number of participants with improvement in endoscopic findings is assessed. | Up to Week 156 | 
| Changes in C-reactive Protein (CRP) | The change in CRP from baseline through the end of the study was assessed. | Up to Week 156 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Humira®, Behcet's Disease, Adalimumab