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 | NCT02790281 | Trialant
CompletedObservationalUpdated Mar 6, 2017
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
ClinicalTrials.gov ID
NCT02790281
Lead Sponsor
Ferring PharmaceuticalsINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
33Actual
Last Update Posted
Mar 6, 2017Actual
Start Date
Dec 2014
Primary Completion Date
Aug 2015Actual
Completion Date
Aug 2015Actual
Brief 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.
Inflammatory Bowel Disease
Blood sampling
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No data available
Eligibility Criteria
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
Observational Model
Cohort
Time Perspective
Prospective
No central contacts
There are no central contacts for this study.
Herlev hospital (there may be other sites in this country)
Herlev, Denmark
Skane University Hospital (there may be other sites in this country)