Special Investigation in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation on Long-Term Administration Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947816
• Other study ID #: P14-190
• Status: Completed
• Start date: August 9, 2013
• Est. completion date: February 15, 2018

Study information

• Verified date: November 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1621
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions	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.	Up to Week 52
Secondary	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)
Secondary	Change From Baseline in Mayo Score Over Time	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.	Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)
Secondary	Mayo Endoscopic Sub-Score Over Time	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).	Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)
Secondary	Change From Baseline in Partial Mayo Score Over Time	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.	Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)

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