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.

  1. Unknown adverse reactions (in particular, clinically significant)
  2. Incidence and conditions of occurrence of adverse reactions in clinical practice
  3. 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 ]

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


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