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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sampling

Blood sample collected at a single visit

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No