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.
- Incidence and conditions of occurrence of adverse reactions in clinical practice
- 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 ]
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