Trial Outcomes & Findings for Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus (NCT NCT00285779)
NCT ID: NCT00285779
Last Updated: 2018-03-21
Results Overview
Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level \>=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-03-21
Participant Flow
This is a randomized, multi-center interventional trial in which patients were recruited at 11 sites in the United States (10 academic and one private practice). Enrollment was between June, 2006 and December, 2008. The first subject was enrolled in August, 2006 and the last patient was enrolled in November, 2008.
Participant milestones
| Measure |
Placebo Injection
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Placebo-controlled Period (wk 1-12)
STARTED
|
14
|
13
|
|
Placebo-controlled Period (wk 1-12)
COMPLETED
|
11
|
12
|
|
Placebo-controlled Period (wk 1-12)
NOT COMPLETED
|
3
|
1
|
|
Open Label Period (wk 12-24)
STARTED
|
11
|
12
|
|
Open Label Period (wk 12-24)
COMPLETED
|
9
|
10
|
|
Open Label Period (wk 12-24)
NOT COMPLETED
|
2
|
2
|
|
Follow-up Period (wk 24-32)
STARTED
|
9
|
10
|
|
Follow-up Period (wk 24-32)
COMPLETED
|
8
|
10
|
|
Follow-up Period (wk 24-32)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Etanercept in the Treatment of Moderate to Severe Lichen Planus
Baseline characteristics by cohort
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intention to treat analysis (all participants received at least one dose of study drug). Missing data imputed using Last Observation Carried Forward (LOCF).
Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level \>=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
The Percentage of Patients Achieving a Response in Mucosal Disease (or Cutaneous Disease if no Mucosal Disease) at 12 Weeks
|
28.6 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. Subjects had a level \>=3 at baseline. To be considered a responder, the subject must achieve a level of 0 or 1, or, at least a 2 point improvement in the scale.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Count of Patients Achieving a Response in Cutaneous or Mucosal Disease at 24 Weeks
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 12; Week 24Population: Participants with missing data were excluded from the analysis.
The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks
Baseline
|
1.2 units on a scale
Standard Deviation 1.31
|
1.6 units on a scale
Standard Deviation 1.73
|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks
Week 12
|
0.8 units on a scale
Standard Deviation 1.03
|
1.5 units on a scale
Standard Deviation 1.44
|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Oral Disease at 12 and 24 Weeks
Week 24
|
1.1 units on a scale
Standard Deviation 1.10
|
1.5 units on a scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Baseline; Week 12; Week 24Population: Participants with missing data were excluded from the analysis.
The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks
Baseline
|
0.3 units on a scale
Standard Deviation 0.82
|
0.4 units on a scale
Standard Deviation 1.33
|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks
Week 12
|
0.5 units on a scale
Standard Deviation 0.96
|
0.4 units on a scale
Standard Deviation 1.38
|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Genital Disease at 12 and 24 Weeks
Week 24
|
0.7 units on a scale
Standard Deviation 1.05
|
0.5 units on a scale
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline; Week 12; Week 24Population: Participants with missing data were excluded from the analysis.
The percentage of surface area involved with disease is reported as assessed by the physician using a Likert scale. Assessment scores range from 0-5, with lower scores corresponding lower percentage of surface area with disease. 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50%.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks
Week 12
|
2.2 units on a scale
Standard Deviation 1.77
|
1.7 units on a scale
Standard Deviation 1.43
|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks
Week 24
|
1.0 units on a scale
Standard Deviation 0.94
|
1.6 units on a scale
Standard Deviation 1.36
|
|
The Physician Assessment of Surface Area of Disease (PSAD) for Skin Disease at 12 and 24 Weeks
Baseline
|
2.8 units on a scale
Standard Deviation 1.56
|
1.8 units on a scale
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: Week 12; Week 24Population: Participants with missing data were excluded from the analysis
This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse erythema. 0=clear, 1=mild/pink, 2=moderately red, 3=severely red/violaceous.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks
Baseline
|
2.5 units on a scale
Standard Deviation 0.76
|
2.3 units on a scale
Standard Deviation 0.67
|
|
Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks
Week 12
|
1.6 units on a scale
Standard Deviation 1.30
|
1.8 units on a scale
Standard Deviation 0.83
|
|
Cutaneous Target Lesion Scores - Erythema, at 12 and 24 Weeks
Week 24
|
0.9 units on a scale
Standard Deviation 1.05
|
1.8 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Week 12; Week 24Population: Participants with missing data were excluded from the analysis
This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse elevation. 0=flat, 1=barely palpable (\<0.5 mm), 2=moderate (0.5 mm-1 mm), 3=severe (\>1 mm).
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks
Baseline
|
2.1 units on a scale
Standard Deviation 0.64
|
2.1 units on a scale
Standard Deviation 0.87
|
|
Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks
Week 12
|
1.5 units on a scale
Standard Deviation 1.16
|
1.6 units on a scale
Standard Deviation 0.70
|
|
Cutaneous Target Lesion Scores - Elevation, at 12 and 24 Weeks
Week 24
|
1.0 units on a scale
Standard Deviation 1.22
|
0.8 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Week 12; Week 24Population: Participants with missing data were excluded from the analysis
This is an investigator-based assessment of a single preselected target skin lesion. Assessment scores range from 0-3 on a Likert scale, with higher scores meaning worse scaling. 0=none, 1=fine/dusty scale, 2=moderate scale, 3=thick/tenacious scale.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks
Baseline
|
0.9 units on a scale
Standard Deviation 0.76
|
1.2 units on a scale
Standard Deviation 0.79
|
|
Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks
Week 12
|
0.8 units on a scale
Standard Deviation 0.72
|
0.8 units on a scale
Standard Deviation 0.66
|
|
Cutaneous Target Lesion Scores - Scale, at 12 and 24 Weeks
Week 24
|
0.4 units on a scale
Standard Deviation 0.99
|
0.8 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Week 12; Week 24Population: Participants with missing data were excluded from the analysis
This score sums all of the 3 elements of the target lesion score (erythema, elevation, scale) described in Outcome Measures 6-8. Assessment scores range from 0-9 on a Likert scale, with higher numbers meaning more severe disease in the target skin lesion.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks
Baseline
|
4.7 units on a scale
Standard Deviation 2.55
|
3.9 units on a scale
Standard Deviation 3.02
|
|
Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks
Week 12
|
3.1 units on a scale
Standard Deviation 3.10
|
2.5 units on a scale
Standard Deviation 2.50
|
|
Cutaneous Target Lesion Scores - Total, at 12 and 24 Weeks
Week 24
|
1.3 units on a scale
Standard Deviation 2.52
|
2.4 units on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Baseline; Week 12; Week 24Population: Participants with missing data were excluded from the analysis.
Participants were asked to indicate their pain level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less pain, higher scores correspond to more pain.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks
Baseline
|
3.8 units on a scale
Standard Deviation 3.08
|
3.4 units on a scale
Standard Deviation 2.50
|
|
Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks
Week 12
|
3.4 units on a scale
Standard Deviation 3.08
|
3.0 units on a scale
Standard Deviation 2.85
|
|
Patient Assessment of Pain on a Visual Analogue Scale (VAS) at 12 and 24 Weeks
Week 24
|
2.4 units on a scale
Standard Deviation 2.83
|
2.8 units on a scale
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: Baseline; Week 12; Week 24Population: Participants with missing data were excluded from the analysis.
Participants were asked to indicate their itching level by marking it on a 10 cm linear VAS scale. The number of centimeters from the left end of the line to the mark was measured in cm. Total range was 0-10. Lower scores correspond to less itching, higher scores correspond to more itching.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Patient Assessment of Pruritus (Itching) on a Visual Analogue Scale (VAS) at 12 and 24 Weeks
Baseline
|
3.8 units on a scale
Standard Deviation 2.84
|
3.2 units on a scale
Standard Deviation 2.55
|
|
Patient Assessment of Pruritus (Itching) on a Visual Analogue Scale (VAS) at 12 and 24 Weeks
Week 12
|
3.3 units on a scale
Standard Deviation 3.38
|
3.4 units on a scale
Standard Deviation 3.14
|
|
Patient Assessment of Pruritus (Itching) on a Visual Analogue Scale (VAS) at 12 and 24 Weeks
Week 24
|
1.5 units on a scale
Standard Deviation 1.64
|
3.0 units on a scale
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Baseline; Week 12; Week 24Population: Participants with missing data were excluded from the analysis.
Participants were asked to indicate their rate their overall assessment of disease severity compared to where it was at their baseline visit. The scale ranges from 0-5, with lower scores correspond to more disease improvement. 0=clear/no disease, 1=much improved (\>75% improved), 2=improved (25-75%), 3=minimally improved (\<25%), 4=no change, 5=worsened disease.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks
Baseline
|
3.9 units on a scale
Standard Deviation 0.87
|
4.1 units on a scale
Standard Deviation 0.54
|
|
Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks
Week 12
|
2.3 units on a scale
Standard Deviation 1.56
|
3.1 units on a scale
Standard Deviation 1.23
|
|
Patient Assessment of Overall Disease Severity (Patient Global Assessment) at 12 and 24 Weeks
Week 24
|
2.9 units on a scale
Standard Deviation 1.46
|
2.6 units on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Baseline; Week 12; Week 24A serious adverse event was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=13 Participants
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
The Count of Subjects Experiencing Serious Adverse Events (SAEs) by Week 12 and Week 24
SAE by week 12
|
0 Participants
|
0 Participants
|
|
The Count of Subjects Experiencing Serious Adverse Events (SAEs) by Week 12 and Week 24
SAE by week 24
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Only participants in the Placebo injection group were evaluated for this outcome measure.
A complete response is defined as a score of 0 (representing "no disease") on the Physician Global Assessment. Physician global assessment of disease scores: 0=clear; 1=minimal disease; 2=mild disease; 3=moderate disease; 4=severe disease. This endpoint is the number of patients on placebo that had any score other than 0 on this measure.
Outcome measures
| Measure |
Placebo Injection
n=14 Participants
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
The Count of Placebo Patients Who do Not Have a Complete Response (Defined as a Physician Global Assessment of "Clear") at 12 Weeks
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Data were not collected for this outcome measure
Outcome measures
Outcome data not reported
Adverse Events
Placebo Injection
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Etanercept
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Injection
n=14 participants at risk
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=24 participants at risk
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
Other adverse events
| Measure |
Placebo Injection
n=14 participants at risk
Placebo: Normal saline twice weekly for 12 weeks
|
Etanercept
n=24 participants at risk
Etanercept: etanercept 50 mg twice weekly for 12 weeks
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema at injection site
|
7.1%
1/14 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Skin and subcutaneous tissue disorders
Bruising at injection site
|
7.1%
1/14 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
12.5%
3/24 • Number of events 3 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
Vaginal yeast infection
|
7.1%
1/14 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
8.3%
2/24 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Renal and urinary disorders
Bladder spasms
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Surgical and medical procedures
Cataract surgery
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
8.3%
2/24 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Surgical and medical procedures
Knee surgery
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Gout flare
|
7.1%
1/14 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
0.00%
0/24 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Musculoskeletal and connective tissue disorders
worsening diffuse joint pains
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
8.3%
2/24 • Number of events 3 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Knee arthritis
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Musculoskeletal and connective tissue disorders
Ankle and finger swelling
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Musculoskeletal and connective tissue disorders
increased back pain
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
8.3%
2/24 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Nervous system disorders
Vertigo
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Immune system disorders
Allergies
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
12.5%
3/24 • Number of events 3 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
2/14 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
8.3%
2/24 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
otitis media
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Gastrointestinal disorders
Oral pain with eating
|
7.1%
1/14 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
0.00%
0/24 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Gastrointestinal disorders
sore throat
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
8.3%
2/24 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
oral candidiasis
|
7.1%
1/14 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
0.00%
0/24 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Vascular disorders
facial flushing
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
0.00%
0/24 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chest congestion
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
8.3%
2/24 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Gastrointestinal disorders
Stomach cramps
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Injury, poisoning and procedural complications
Food poisoning
|
7.1%
1/14 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
0.00%
0/24 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
8.3%
2/24 • Number of events 2 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Gastrointestinal disorders
gastric reflux
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Skin and subcutaneous tissue disorders
pruritis, generalized
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
Renal and urinary disorders
Elevated creatinine
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
|
General disorders
fever
|
0.00%
0/14 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
4.2%
1/24 • Number of events 1 • This includes the entire 32 week timeframe of the trial. Thus, the placebo patients that cross over to etanercept from 12-24 weeks are also considered in the etanercept group during the 12-24 week timeframe. Also includes followup from 24-32 weeks.
|
Additional Information
David Fiorentino
Stanford University Department of Dermatology
Phone: 650-723-6316
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60