Trial Outcomes & Findings for Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis (NCT NCT00195507)
NCT ID: NCT00195507
Last Updated: 2013-02-25
Results Overview
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
720 participants
Primary outcome timeframe
54 weeks
Results posted on
2013-02-25
Participant Flow
Subjects were recruited in multiple countries worldwide from to.
Subjects were screened up to 4 weeks.
Participant milestones
| Measure |
Continuous
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
|---|---|---|
|
Overall Study
STARTED
|
357
|
363
|
|
Overall Study
COMPLETED
|
258
|
245
|
|
Overall Study
NOT COMPLETED
|
99
|
118
|
Reasons for withdrawal
| Measure |
Continuous
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
|---|---|---|
|
Overall Study
Adverse Event
|
24
|
13
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Failed to Return
|
4
|
3
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Protocol Violation
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
40
|
67
|
|
Overall Study
Withdrawal by Subject
|
16
|
23
|
|
Overall Study
Protocol Deviation
|
6
|
3
|
Baseline Characteristics
Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis
Baseline characteristics by cohort
| Measure |
Continuous
n=357 Participants
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
n=363 Participants
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
Total
n=720 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
44.87 years
STANDARD_DEVIATION 11.83 • n=93 Participants
|
45.20 years
STANDARD_DEVIATION 11.88 • n=4 Participants
|
45.03 years
STANDARD_DEVIATION 11.85 • n=27 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
203 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
256 Participants
n=93 Participants
|
261 Participants
n=4 Participants
|
517 Participants
n=27 Participants
|
|
Region of Enrollment
Portugal
|
6 participants
n=93 Participants
|
6 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
9 participants
n=93 Participants
|
8 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Region of Enrollment
Finland
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
19 participants
n=93 Participants
|
19 participants
n=4 Participants
|
38 participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
7 participants
n=93 Participants
|
11 participants
n=4 Participants
|
18 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
13 participants
n=93 Participants
|
11 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
59 participants
n=93 Participants
|
60 participants
n=4 Participants
|
119 participants
n=27 Participants
|
|
Region of Enrollment
Switzerland
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
40 participants
n=93 Participants
|
39 participants
n=4 Participants
|
79 participants
n=27 Participants
|
|
Region of Enrollment
France
|
50 participants
n=93 Participants
|
52 participants
n=4 Participants
|
102 participants
n=27 Participants
|
|
Region of Enrollment
Czech Republic
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
22 participants
n=93 Participants
|
21 participants
n=4 Participants
|
43 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
10 participants
n=93 Participants
|
9 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
23 participants
n=93 Participants
|
25 participants
n=4 Participants
|
48 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
57 participants
n=93 Participants
|
58 participants
n=4 Participants
|
115 participants
n=27 Participants
|
|
Region of Enrollment
Norway
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
16 participants
n=93 Participants
|
17 participants
n=4 Participants
|
33 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 54 weeksPopulation: The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).
Outcome measures
| Measure |
Continuous
n=352 Participants
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
n=359 Participants
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
|---|---|---|
|
Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
|
1.98 units on scale
Standard Deviation 0.86
|
2.51 units on scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: 54 weeksPopulation: The analysis population was the modified intention-to-treat (mITT)population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation. Last observation carried forward (LOCF).
Patients were asked to rate the severity of their psoriasis disease activity on a 6-point scale, where 0=good and 5=severe.
Outcome measures
| Measure |
Continuous
n=348 Participants
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
n=355 Participants
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
|---|---|---|
|
Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline
|
57.03 percentage improvement
|
40.92 percentage improvement
|
SECONDARY outcome
Timeframe: 54 weeksPopulation: The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug, had at least 1 post-baseline evaluation and who achieved a PGA status of 0 or 1 by the last visit (Observed cases).
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=sever psoriasis, 7=clear). This assessment measured the time (in days) from baseline to the visit where a patient achieved a PGA status of 0 or 1. Patients who did not achieve this status by their last visit were not included.
Outcome measures
| Measure |
Continuous
n=352 Participants
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
n=359 Participants
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
|---|---|---|
|
Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"
|
127 days
Interval 124.0 to 161.0
|
168 days
Interval 126.0 to 253.0
|
SECONDARY outcome
Timeframe: 54 weeksPopulation: The analysis population was the modified intention-to-treat (mITT) population, which included all patients who received at least one dose of study drug and had at least 1 post-baseline evaluation.
Patients completed a patient satisfaction survey at baseline and throughout the study. Patients were asked to rate, based on their experienced during the past week, how satisfied or dissatisfied they were with their psoriasis therapy in general. Responses were based on a 7-point scale: Very satisfied, Satisfied, Somewhat Satisfied, Neutral, Somewhat Dissatisfied, Dissatisfied and Very Dissatisfied.
Outcome measures
| Measure |
Continuous
n=352 Participants
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
n=359 Participants
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
|---|---|---|
|
Number of Patients With Survey Response of "Somewhat Satisfied" or Better
Baseline
|
70 participants
|
80 participants
|
|
Number of Patients With Survey Response of "Somewhat Satisfied" or Better
Week 54
|
231 participants
|
198 participants
|
Adverse Events
Continuous
Serious events: 23 serious events
Other events: 281 other events
Deaths: 0 deaths
Intermittent
Serious events: 31 serious events
Other events: 273 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuous
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
|---|---|---|
|
General disorders
Abdominal pain
|
0.28%
1/357
|
0.28%
1/363
|
|
General disorders
Abscess
|
0.28%
1/357
|
0.00%
0/363
|
|
General disorders
Accidental Injury
|
0.84%
3/357
|
0.55%
2/363
|
|
General disorders
Anaphylactoid reaction
|
0.00%
0/357
|
0.28%
1/363
|
|
General disorders
Back pain
|
0.00%
0/357
|
0.28%
1/363
|
|
General disorders
Cellulitis
|
0.28%
1/357
|
0.00%
0/363
|
|
General disorders
Hernia
|
0.00%
0/357
|
0.28%
1/363
|
|
General disorders
Infection
|
0.28%
1/357
|
0.55%
2/363
|
|
General disorders
Lab test abnormal
|
0.28%
1/357
|
0.00%
0/363
|
|
General disorders
Malaise
|
0.28%
1/357
|
0.00%
0/363
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/357
|
0.28%
1/363
|
|
Cardiac disorders
Angina pectoris
|
0.28%
1/357
|
0.00%
0/363
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/357
|
0.28%
1/363
|
|
Cardiac disorders
Hypertension
|
0.56%
2/357
|
0.28%
1/363
|
|
Cardiac disorders
Left heart failure
|
0.00%
0/357
|
0.28%
1/363
|
|
Cardiac disorders
Myocardial infarct
|
0.00%
0/357
|
0.83%
3/363
|
|
Cardiac disorders
Myocardial ischemia
|
0.28%
1/357
|
0.00%
0/363
|
|
Cardiac disorders
Palpitation
|
0.28%
1/357
|
0.00%
0/363
|
|
Vascular disorders
Varicose vein
|
0.28%
1/357
|
0.00%
0/363
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/357
|
0.28%
1/363
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/357
|
0.28%
1/363
|
|
Hepatobiliary disorders
Gamma glutamyl transpeptidase increased
|
0.28%
1/357
|
0.00%
0/363
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.28%
1/357
|
0.00%
0/363
|
|
Gastrointestinal disorders
Gastrointestinal carcinoma
|
0.00%
0/357
|
0.28%
1/363
|
|
Gastrointestinal disorders
Rectal disorder
|
0.28%
1/357
|
0.00%
0/363
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/357
|
0.28%
1/363
|
|
Metabolism and nutrition disorders
Edema
|
0.28%
1/357
|
0.00%
0/363
|
|
Metabolism and nutrition disorders
Peripheral edema
|
0.28%
1/357
|
0.00%
0/363
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
1/357
|
0.00%
0/363
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.00%
0/357
|
0.28%
1/363
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/357
|
0.28%
1/363
|
|
Nervous system disorders
Ataxia
|
0.28%
1/357
|
0.00%
0/363
|
|
Nervous system disorders
Convulsion
|
0.00%
0/357
|
0.28%
1/363
|
|
Nervous system disorders
Dizziness
|
0.28%
1/357
|
0.00%
0/363
|
|
Nervous system disorders
Hypesthesia
|
0.00%
0/357
|
0.28%
1/363
|
|
Nervous system disorders
Incoordination
|
0.00%
0/357
|
0.28%
1/363
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/357
|
0.28%
1/363
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.56%
2/357
|
0.00%
0/363
|
|
General disorders
Nasal septum disorder
|
0.28%
1/357
|
0.00%
0/363
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/357
|
0.28%
1/363
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/357
|
0.28%
1/363
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.28%
1/357
|
1.1%
4/363
|
|
Skin and subcutaneous tissue disorders
Skin carcinoma
|
0.56%
2/357
|
1.1%
4/363
|
|
Reproductive system and breast disorders
Abortion
|
0.00%
0/357
|
0.28%
1/363
|
|
Renal and urinary disorders
Kidney calculus
|
0.28%
1/357
|
0.00%
0/363
|
|
Renal and urinary disorders
Kidney pain
|
0.28%
1/357
|
0.00%
0/363
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/357
|
0.28%
1/363
|
|
Renal and urinary disorders
Testis disorder
|
0.28%
1/357
|
0.00%
0/363
|
|
Reproductive system and breast disorders
Unintended pregnancy
|
0.28%
1/357
|
0.55%
2/363
|
|
Renal and urinary disorders
Urinary tract infection
|
0.28%
1/357
|
0.00%
0/363
|
|
Renal and urinary disorders
Urogenital disorder
|
0.00%
0/357
|
0.28%
1/363
|
Other adverse events
| Measure |
Continuous
etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
|
Intermittent
etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
|
|---|---|---|
|
General disorders
Accidental injury
|
7.8%
28/357
|
9.1%
33/363
|
|
General disorders
Asthenia
|
7.6%
27/357
|
6.1%
22/363
|
|
General disorders
Back pain
|
7.3%
26/357
|
5.0%
18/363
|
|
General disorders
Flu syndrome
|
10.4%
37/357
|
9.4%
34/363
|
|
General disorders
Headache
|
17.6%
63/357
|
12.9%
47/363
|
|
General disorders
Infection
|
6.2%
22/357
|
5.8%
21/363
|
|
General disorders
Injection site reaction
|
5.9%
21/357
|
6.6%
24/363
|
|
General disorders
Pain
|
7.0%
25/357
|
4.7%
17/363
|
|
Cardiac disorders
Hypertension
|
5.3%
19/357
|
2.8%
10/363
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
21/357
|
3.9%
14/363
|
|
Metabolism and nutrition disorders
Metabolic and nutritional
|
5.3%
19/357
|
6.3%
23/363
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
32/357
|
11.0%
40/363
|
|
Nervous system disorders
Nervous
|
13.4%
48/357
|
10.5%
38/363
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
5.3%
19/357
|
6.3%
23/363
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
10.6%
38/357
|
9.9%
36/363
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
5.9%
21/357
|
5.8%
21/363
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
17.9%
64/357
|
17.4%
63/363
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.2%
33/357
|
7.7%
28/363
|
|
Ear and labyrinth disorders
Special senses
|
8.1%
29/357
|
5.5%
20/363
|
|
Renal and urinary disorders
Urogenital
|
5.6%
20/357
|
7.4%
27/363
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER