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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief Summary:

This investigation will be conducted to obtain the following information regarding the use of Adalimumab 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 Summary:
Sponsor: AbbVie

Current Primary Outcome: Number of patients with adverse events [ Time Frame: Up to Week 156 ]

Number of patients with adverse events with evaluation beginning upon administration of Adalimumab


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with overall evaluation of gastrointestinal symptoms [ Time Frame: Up to Week 156 ]
    Evaluation of symptoms including Abdominal pain, Diarrhea, Abdominal fullness, Abdominal tenderness and bleeding
  • Number of patients with evaluation of symptoms of Behcet's disease [ Time Frame: Up to Week 156 ]
    Evaluation of symptoms including Recurrent aphthous ulceration of oral mucosa, Skin symptoms, Eye symptoms, Pudendal ulcer, Arthritis without deformity or rigidity, Epididymal inflammation, Vascular and Central nervous system adverse events
  • Number of patients with degree of improvement of endoscopic findings [ Time Frame: Up to Week 156 ]
  • C-reactive Protein [ Time Frame: Up to Week 156 ]


Original Secondary Outcome: Same as current

Information By: AbbVie

Dates:
Date Received: July 16, 2013
Date Started: July 2013
Date Completion:
Last Updated: May 30, 2017
Last Verified: May 2017