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

Completed

• Conditions: Behcet's Disease

• Registration Number: NCT01960790
• Lead Sponsor: AbbVie

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.

1. Incidence and conditions of occurrence of adverse reactions in clinical practice

2. Factors likely to affect the safety and effectiveness

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-25
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-10-10
• Study First Posted: 2013-10-11
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Status Verified: 2018-05
• Results First Submitted: 2018-05-03
• Results First Submitted QC: 2018-12-19
• Last Update Submitted: 2018-12-19
• Results First Posted: 2019-03-22
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	Up to Week 156	The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease	Up to Week 156	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.
Number of Participants With Cardinal Symptoms of Behcet's Disease	Up to Week 156	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.
Changes in C-reactive Protein (CRP)	Up to Week 156	The change in CRP from baseline through the end of the study was assessed.
Number of Participants With Accessory Symptoms of Behcet's Disease	Up to Week 156	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.
Number of Participants With Degree of Improvement of Endoscopic Findings	Up to Week 156	The number of participants with improvement in endoscopic findings is assessed.
Global Assessment of Gastrointestinal Symptoms	Up to Week 156	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.