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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01960790
Other study ID # P14-152
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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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