Trial Outcomes & Findings for 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 (NCT NCT02790281)
NCT ID: NCT02790281
Last Updated: 2017-03-06
Results Overview
Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.
COMPLETED
33 participants
At Day 1
2017-03-06
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Overall Study
n=33 Participants
Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) \>5 mg/L.
|
|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 16.41 • n=5 Participants
|
|
Gender
Female
|
16 Participants
n=5 Participants
|
|
Gender
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 1Population: All eligible subjects with CRP \>5 mg/L.
Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.
Outcome measures
| Measure |
Overall Study
n=33 Participants
Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) \>5 mg/L.
|
|---|---|
|
Exploratory: Levels of IL-6/sIL-6R Complex
|
NA pg/mL
Levels of IL-6/sIL6-R complex were below level of detection.
|
PRIMARY outcome
Timeframe: At Day 1Population: All eligible subjects with CRP \>5 mg/L
Blood sample was taken for analysis of levels of IL-6.
Outcome measures
| Measure |
Overall Study
n=33 Participants
Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) \>5 mg/L.
|
|---|---|
|
Exploratory: Levels of IL-6
|
NA pg/mL
Levels of IL-6 were below level of detection.
|
PRIMARY outcome
Timeframe: At Day 1Population: All eligible subjects with CRP \>5 mg/L
Blood sample was taken for analysis of levels of CRP.
Outcome measures
| Measure |
Overall Study
n=33 Participants
Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn's disease and C-reactive protein (CRP) \>5 mg/L.
|
|---|---|
|
Exploratory: Levels of C-reactive Protein (CRP)
|
NA mg/L
Levels of CRP were below level of detection.
|
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Manuscripts or abstracts will be prepared in collaboration between Ferring and the Investigators.
- Publication restrictions are in place
Restriction type: OTHER