Inflammatory Bowel Disease
Conditions
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.
Interventions
PROCEDUREBlood sampling
Blood sample collected at a single visit
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Denmark, Sweden
Participant flow
Recruitment details
Subjects were recruited from amongst the subjects seeking medical support due to present, active moderate to severe ulcerative colitis or Crohn's disease (newly diagnosed or during disease relapse) at four sites in two countries (Denmark and Sweden) between 10 Dec 2014 to 20 Aug 2015.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) \>5 mg/L. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 16.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gender Female | 16 Participants |
| Gender Male | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Exploratory: Levels of C-reactive Protein (CRP)
Blood sample was taken for analysis of levels of CRP.
Time frame: At Day 1
Population: All eligible subjects with CRP \>5 mg/L
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Exploratory: Levels of C-reactive Protein (CRP) | NA mg/L |
Primary
Exploratory: Levels of IL-6
Blood sample was taken for analysis of levels of IL-6.
Time frame: At Day 1
Population: All eligible subjects with CRP \>5 mg/L
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Exploratory: Levels of IL-6 | NA pg/mL |
Primary
Exploratory: Levels of IL-6/sIL-6R Complex
Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.
Time frame: At Day 1
Population: All eligible subjects with CRP \>5 mg/L.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Exploratory: Levels of IL-6/sIL-6R Complex | NA pg/mL |