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Completed

NCT Number: NCT01960790

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

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

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Key information

Conditions

Behcet's Disease Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Mouth Diseases Panuveitis Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Drug Reactions

    Time frame: Up to Week 156

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

Secondary outcomes

  1. Global Assessment of Gastrointestinal Symptoms

    Time frame: 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.

  2. Global Assessment of Gastrointestinal Symptoms of Behcet's Disease

    Time frame: 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.

  3. Number of Participants With Cardinal Symptoms of Behcet's Disease

    Time frame: 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.

  4. Number of Participants With Accessory Symptoms of Behcet's Disease

    Time frame: 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.

  5. Number of Participants With Degree of Improvement of Endoscopic Findings

    Time frame: Up to Week 156

    The number of participants with improvement in endoscopic findings is assessed.

  6. Changes in C-reactive Protein (CRP)

    Time frame: Up to Week 156

    The change in CRP from baseline through the end of the study was assessed.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 11, 2013
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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