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
Completed
- Conditions
- Inflammatory Bowel Disease
- Registration Number
- NCT02790281
- Lead Sponsor
- Ferring Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Exploratory: Levels of IL-6 At Day 1 Blood sample was taken for analysis of levels of IL-6.
Exploratory: Levels of C-reactive Protein (CRP) At Day 1 Blood sample was taken for analysis of levels of CRP.
Exploratory: Levels of IL-6/sIL-6R Complex At Day 1 Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Skane University Hospital (there may be other sites in this country)
🇸🇪Lund, Sweden
Herlev hospital (there may be other sites in this country)
🇩🇰Herlev, Denmark