Special Investigation in Patients With Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT01947816
• Lead Sponsor: AbbVie

Brief Summary

This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL 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 Description

Not available

Study Timeline

• Study Start: 2013-08-09
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-23
• Primary Completion: 2018-02-15
• Study Completion: 2018-02-15
• Status Verified: 2018-11
• Results First Submitted: 2019-01-31
• Results First Submitted QC: 2019-05-10
• Last Update Submitted: 2019-05-10
• Results First Posted: 2019-05-13
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1621

Inclusion Criteria

• Patients receiving Humira for the first time for the treatment of Ulcerative Colitis

Exclusion Criteria

Contraindications according to the Package Insert include patients who have 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions	Up to Week 52	Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in CRP Levels Over Time	Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52)
Change From Baseline in Mayo Score Over Time	Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)	The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.
Change From Baseline in Partial Mayo Score Over Time	Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)	The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.
Mayo Endoscopic Sub-Score Over Time	Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)	The endoscopist evaluated each observed segment of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) by using the classification as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).