Fecal Calprotectin Levels, QoL and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

Moderate to Severe Ulcerative Colitis Clinical Trial

— AdaProQuo  

Official title:

Fecal Calprotectin Levels, QoL and Workability in Patients Suffering From Ulcerative Colitis Under Adalimumab Therapy - AdaProQuo

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02092389
• Other study ID #: P14-323
• Status: Terminated
• Phase: N/A
• First received: March 18, 2014
• Last updated: December 21, 2015
• Start date: July 2014
• Est. completion date: March 2017

Study information

• Verified date: December 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial Summary

The objectives of this study are to explore the effect of adalimumab on the fecal Calprotectin level of Ulcerative Colitis (UC) patients and the correlation with their general well-being (QoL), work ability and disease activity.

Description:

This is a non-interventional, observational study in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of the patient to a Humira containing regimen has to be decided in advance and has to be current practice. The prescription of Humira is clearly separated from the decision to include the participant in this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria: - Patients with moderate to severe Ulcerative Colitis who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (AZA/6-MP); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC

• Patients which are able to complete patients questionnaires (like WPAI:UC and sIBDQ questionnaire)

• Patients must fulfill national and international guidelines for the use of biologic therapies in Ulcerative Colitis (Chest X-ray and Interferon-Gamma-Release Assay (IGRA) or tuberculin purified protein derivative (PPD)-skin test negative for tuberculosis).

• Patients who have been prescribed adalimumab in line with the European SmPC (Summary of Product Characteristics)

Exclusion Criteria: - Previous therapy with TNF-alpha (Tumor necrosis factor alpha) blocker

• no signed written authorization to use data

• Contraindication to adalimumab therapy according to the Summary of Product Characteristics (SmPC)

• Subjects with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or planned bowel surgery.

• Subjects received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening period.

• pregnant subjects

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Moderate to Severe Ulcerative Colitis
• Ulcer

Locations

Country	Name	City	State
Austria	Site Reference ID/Investigator# 129655	Innsbruck
Austria	Site Reference ID/Investigator# 129659	Linz
Austria	Site Reference ID/Investigator# 129663	Oberpullendorf
Austria	Site Reference ID/Investigator# 138270	Salzburg
Austria	Site Reference ID/Investigator# 129661	St. Poelten
Austria	Site Reference ID/Investigator# 129656	St. Veit an der Glan
Austria	Site Reference ID/Investigator# 129657	Vienna
Austria	Site Reference ID/Investigator# 129658	Vienna
Austria	Site Reference ID/Investigator# 129660	Vienna
Austria	Site Reference ID/Investigator# 129662	Vienna
Austria	Site Reference ID/Investigator# 129664	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Percentage of patients with fecal calprotectin level <= 150µg/g	Calprotectin levels should be measured using Enzyme Linked Immunosorbent Assay (ELISA) and / or a validated quantitative rapid test	from month 0 to month 12	No
Secondary	Change in patients workability measured with the Work Productivity and Activity Impairment (WPAI):UC questionnaire	The Work Productivity and Activity Impairment (WPAI) questionnaire measures work time missed and work and activity impairment due to a specified health problem during the past 7 days.	from Day 0 to month 12	No
Secondary	Correlation of fecal Calprotectin	the correlation of fecal Calprotectin levels in µg/g measured using ELISA and / or a validated quantitative rapid test	Up to month 12	No
Secondary	Disease Activity Score (DAS)	Assessed using partial Mayo score	Up to month 12	No
Secondary	Correlation of disease activity	the correlation disease activity using the partial Mayo Score.	up to month 12	No
Secondary	Correlation of quality of life	the correlation of QoL using the sIBDQ questionnaire	up to month 12	No
Secondary	Correlation of workability	the correlation of workability using the WPAI:UC questionnaire.	up to month 12	No
Secondary	Change in patients QoL measured with the sIBDQ (small Inflammatory Bowl Disease Questionnaire) questionnaire	The small Inflammatory Bowl Disease Questionnaire (sIBDQ) measures the QoL of patients with Inflammatory Bowl Disease	from Day 0 to month 12	No