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 | Completed Results

• 1 other identifier: 07031-01
• Study Type: observational
• Target: 33
• Locations: 2 countries
• Sites: 2

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.

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (3)

• Exploratory: Levels of IL-6/sIL-6R Complex

  Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.

  At Day 1

• Exploratory: Levels of IL-6

  Blood sample was taken for analysis of levels of IL-6.

  At Day 1

• Exploratory: Levels of C-reactive Protein (CRP)

  Blood sample was taken for analysis of levels of CRP.

  At Day 1

Interventions

Blood sampling PROCEDURE

Blood sample collected at a single visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men and women seeking medical support due to present, active moderate to severe ulcerative colitis or Crohn's disease (newly diagnosed or during disease relapse).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (2)

Herlev hospital (there may be other sites in this country)

Herlev, Denmark

Location

Skane University Hospital (there may be other sites in this country)

Lund, Sweden

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 3, 2016
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

DK (1); SE (1)