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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood sample collected at a single visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev hospital (there may be other sites in this country) | Herlev | Denmark | ||||
| Skane University Hospital (there may be other sites in this country) |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lund |
| Sweden |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set, consisted of all eligible subjects with CRP >5 mg/L.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exploratory: Levels of IL-6/sIL-6R Complex | Blood sample was taken for analysis of levels of IL-6/sIL6-R complex. | All eligible subjects with CRP >5 mg/L. | Posted | Median | Full Range | pg/mL | At Day 1 |
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| |||||||||||||||||||||||||
| Primary | Exploratory: Levels of IL-6 | Blood sample was taken for analysis of levels of IL-6. | All eligible subjects with CRP >5 mg/L | Posted | Median | Full Range | pg/mL | At Day 1 |
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| ||||||||||||||||||||||||||
| Primary | Exploratory: Levels of C-reactive Protein (CRP) | Blood sample was taken for analysis of levels of CRP. | All eligible subjects with CRP >5 mg/L | Posted | Median | Full Range | mg/L | At Day 1 |
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No data for adverse event was collected in this study as no investigational medicinal product was administered to the subjects.
Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 |
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Manuscripts or abstracts will be prepared in collaboration between Ferring and the Investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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