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NCT02790281 Clinical Trial

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

Inflammatory Bowel Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02790281
Other study ID # 07031-01
Secondary ID
Status Completed
Phase N/A
First received May 18, 2016
Last updated June 2, 2016
Start date December 2014
Est. completion date August 2015

Study information
Verified date May 2016
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeSweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sampling
Blood sample collected at a single visit

Locations
Country Name City State
Denmark Herlev hospital (there may be other sites in this country) Herlev
Sweden Skane University Hospital (there may be other sites in this country) Lund

Sponsors (1)
Lead Sponsor Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Exploratory: Levels of IL-6/sIL-6R complex At visit 1
Primary Exploratory: Levels of IL-6 At visit 1
Primary Exploratory: Levels of C-reactive protein (CRP) At visit 1
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