N/A
Completed N=33
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
Source: ClinicalTrials.gov NCT02790281 ↗Enrolled (actual)
33
Serious AEs
—
Results posted
Mar 2017
Primary outcomePrimary: Exploratory: Levels of IL-6/sIL-6R Complex — NA pg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exploratory: Levels of IL-6/sIL-6R Complex |
NA | — |
| PRIMARY Exploratory: Levels of IL-6 |
NA | — |
| PRIMARY Exploratory: Levels of C-reactive Protein (CRP) |
NA | — |
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
Data sourced from ClinicalTrials.gov (NCT02790281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.