Special Investigation in Patients With Ulcerative Colitis

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions

Time frame: 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 outcomes

Change From Baseline in CRP Levels Over Time

Time frame: 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

Time frame: 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.
Mayo Endoscopic Sub-Score Over Time

Time frame: 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).
Change From Baseline in Partial Mayo Score Over Time

Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Sep 23, 2013
Registry last updated: May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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