A Study to Investigate Interleukin-6 (IL-6) and IL-6/Soluble IL-6 Receptor (sIL-6R) Complex Levels in Subjects With Active Inflammatory Bowel Disease

January 13, 2017 updated by: Ferring Pharmaceuticals
The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with active moderate to severe ulcerative colitis or Crohn's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark
        • Herlev hospital (there may be other sites in this country)
  • Sweden
      • Lund, Sweden
        • Skane University Hospital (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men and women seeking medical support due to present, active moderate to severe ulcerative colitis or Crohn's disease (newly diagnosed or during disease relapse).

Description

Inclusion Criteria:

  • Subjects diagnosed with active moderate to severe ulcerative colitis (*partial Mayo ≥ 5) or Crohn's disease (Harvey & Bradshaw ≥ 8) *partial Mayo: 9-point scale that excludes the endoscopic components of the Mayo score

Exclusion Criteria:

  • Presence of another inflammatory disease, except for mild cutaneous psoriasis
  • Concomitant gastrointestinal infection or otherwise serious infection including Crohn's disease infectious complication
  • Treatment with Infliximab, Adalimumab, Certolizumab Pegol or other immune-modulating biologics within 8 weeks prior to the visit
  • Having a known or suspected gastrointestinal or otherwise serious infection within 8 weeks prior to the visit
  • Concomitant diagnosed or suspected malignant disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory: Levels of IL-6/sIL-6R Complex
Time Frame: At Day 1
Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.
At Day 1
Exploratory: Levels of IL-6
Time Frame: At Day 1
Blood sample was taken for analysis of levels of IL-6.
At Day 1
Exploratory: Levels of C-reactive Protein (CRP)
Time Frame: At Day 1
Blood sample was taken for analysis of levels of CRP.
At Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07031-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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