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

Behcet's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960790
• Other study ID #: P14-152
• Status: Completed
• Start date: May 25, 2013
• Est. completion date: May 15, 2017

Study information

• Verified date: May 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in C-reactive Protein (CRP)	The change in CRP from baseline through the end of the study was assessed.	Up to Week 156

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