Trial Outcomes & Findings for Psoriasis Inflammation and Systemic Co Morbidities (NCT NCT01170715)
NCT ID: NCT01170715
Last Updated: 2021-02-08
Results Overview
To analyze specimens using histology and gene expression before, during, and after treatment.
COMPLETED
NA
29 participants
From baseline, every 3 months, up to one year (52 weeks).
2021-02-08
Participant Flow
29 subjects were screened but only 21 out of this meet inclusion/exclusion criteria and were assigned to the study
Participant milestones
| Measure |
Experimental Group
Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.
Etanercept: self-administered for 52 weeks
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psoriasis Inflammation and Systemic Co Morbidities
Baseline characteristics by cohort
| Measure |
Experimental Group
n=21 Participants
Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.
Etanercept: self-administered for 52 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline, every 3 months, up to one year (52 weeks).Population: Cell count was never performed
To analyze specimens using histology and gene expression before, during, and after treatment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From baseline, every 3 months, up to one year (52 weeks). Except at 9 months. Biopsies were taken at baseline, 3 months, 6 months and 12 months.Population: 1 participant was not included
To analyze specimens using histology and gene expression before, during, and after treatment. Percentage Change in IL17A gene expression is the mean of change from baseline divided by mean of baseline and then multiplied by 100: 100\*(PostTreatment-Baseline)/Baseline. Both PostTreatment and Baseline values are means but the percentage is a number.
Outcome measures
| Measure |
Experimental Group
n=20 Participants
Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.
Etanercept: self-administered for 52 weeks
|
|---|---|
|
Percentage Change in IL17A Gene Expression
6 months (IL17A)
|
-99.08 percent change
|
|
Percentage Change in IL17A Gene Expression
3 months (IL17A)
|
-98.57 percent change
|
|
Percentage Change in IL17A Gene Expression
12 months (IL17A)
|
-99.66 percent change
|
SECONDARY outcome
Timeframe: From baseline, every 3 months, up to one year (52 weeks). Biopsies were taken at baseline, 3 months, 6 months, 9 months and 12 months.Population: 1 participant was not included
To analyze immunological biomarkers of inflammation in the blood using electrochemiluminescence of the MSD systems approach hs-CRP, IL-2 Receptor, Plasminogen activator inhibitor complex (PAI), tissue plasminogen activator (TPA), anti pro BNP, E-selectin, inflammatory cytokines and markers, metabolic markers, vascular markers \[IL= interleukin; MMP =Matrix metallopeptidase; ICAM=Inter-Cellular Adhesion Molecule; VCAM= vascular cell adhesion molecule; SAA=Serum amyloid A;GLP-1= Glucagon-like peptide-1;CRP C-Reactive protein. The markers list: IFN-γ, IL-2, IL-4, IL-5, IL-10, IL-12p70, IL-13, IFN-γ, IL-2, IL-4, IL-5, IL-10, IL-12p70, IL-13, MMP- 1, MMP-3 and MMP-9, CRP, sICAM-1, sVCAM-1, SAA, adiponectin, GLP-1,insulin, resistin and other future markers not known at this time. Percentage Change in IL17A is the mean of change from baseline divided by mean of baseline and then multiplied by 100: 100\*(PostTreatment-Baseline)/Baseline
Outcome measures
| Measure |
Experimental Group
n=20 Participants
Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.
Etanercept: self-administered for 52 weeks
|
|---|---|
|
Percentage of Change in IL17A.
3 months (IL17A)
|
-150 percent change
|
|
Percentage of Change in IL17A.
6 months (IL17A)
|
-107 percent change
|
|
Percentage of Change in IL17A.
9 months (IL17A)
|
-179 percent change
|
|
Percentage of Change in IL17A.
12 months (IL17A)
|
-111 percent change
|
Adverse Events
Experimental Group
Serious adverse events
| Measure |
Experimental Group
n=21 participants at risk
Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.
Etanercept: self-administered for 52 weeks
|
|---|---|
|
Skin and subcutaneous tissue disorders
cellulitis
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
General disorders
alcohol detox
|
4.8%
1/21 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Experimental Group
n=21 participants at risk
Enbrel (etanercept): started with self-injection of 50 mg subcutaneous twice weekly for 12 weeks, followed by self-injection of 50 mg subcutaneous weekly for 40 weeks.
Etanercept: self-administered for 52 weeks
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
28.6%
6/21 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
gum infection
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
vomiting
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
rash
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
General disorders
insomnia
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Infections and infestations
biopsy wound infection
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
General disorders
fatigue
|
9.5%
2/21 • Number of events 2 • 1 year
|
|
Infections and infestations
urinary tract infection
|
4.8%
1/21 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
rectal abscess
|
4.8%
1/21 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place