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

N/ACompletedNCT01960790

AbbVie473 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

473

Conditions

Behcet's Disease

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Adverse Drug Reactions

The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.

Time frame: Up to Week 156

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Week 156

Data from ClinicalTrials.gov

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