Clinical Trial: Special Investigation in Patients With Ulcerative Colitis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Special Investigation in Patients With Ulcerative Colitis
Brief Summary:
This investigation will be conducted to obtain the following information regarding the use of Humira 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Ulcerative Colitis.
- Unknown adverse reactions (in particular, clinically significant)
- 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 52 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Full Mayo score [ Time Frame: Up to week 52 ]
- Partial Mayo score [ Time Frame: Up to week 52 ]
- C-reactive Protein [ Time Frame: Up to week 52 ]
- Mayo endoscopic sub-score [ Time Frame: Up to week 52 ]
Original Secondary Outcome: Same as current
Information By: AbbVie
Dates:
Date Received: September 18, 2013
Date Started: August 9, 2013
Date Completion: July 28, 2017
Last Updated: April 21, 2017
Last Verified: April 2017