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

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.

Completed

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev hospital (there may be other sites in this country), Herlev, Denmark

Who can participate

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

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

Treatment and study plan

blood sampling

Procedure

Blood sample collected at a single visit

Primary outcomes

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.
Exploratory: Levels of IL-6

Time frame: At Day 1

Blood sample was taken for analysis of levels of IL-6.
Exploratory: Levels of C-reactive Protein (CRP)

Time frame: At Day 1

Blood sample was taken for analysis of levels of CRP.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jun 3, 2016
Registry last updated: Mar 6, 2017

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.

Completed