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

Ferring

Status: Completed

Conditions: Inflammatory Bowel Disease

Treatments: Procedure: Blood sampling

Study type: Observational

Funder types: Industry

Identifiers

NCT02790281

07031-01

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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