Trial Outcomes & Findings for Moderate to Severe Plaque Psoriasis With Scalp Involvement (NCT NCT00791765)
NCT ID: NCT00791765
Last Updated: 2014-07-23
Results Overview
The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
124 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2014-07-23
Participant Flow
Participants were enrolled from 5 December 2008 through 6 January 2010
Participant milestones
| Measure |
Placebo BIW/Etanercept 50 mg BIW
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
|---|---|---|
|
Weeks 1 to 12
STARTED
|
62
|
62
|
|
Weeks 1 to 12
Treated
|
62
|
59
|
|
Weeks 1 to 12
COMPLETED
|
54
|
58
|
|
Weeks 1 to 12
NOT COMPLETED
|
8
|
4
|
|
Weeks 13 to 24
STARTED
|
54
|
57
|
|
Weeks 13 to 24
COMPLETED
|
49
|
49
|
|
Weeks 13 to 24
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Placebo BIW/Etanercept 50 mg BIW
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
|---|---|---|
|
Weeks 1 to 12
Adverse Event
|
0
|
1
|
|
Weeks 1 to 12
Lost to Follow-up
|
1
|
0
|
|
Weeks 1 to 12
Withdrawal by Subject
|
3
|
0
|
|
Weeks 1 to 12
Physician Decision
|
1
|
0
|
|
Weeks 1 to 12
Disease progression
|
3
|
0
|
|
Weeks 1 to 12
Ineligibility determined
|
0
|
3
|
|
Weeks 13 to 24
Protocol deviation
|
2
|
0
|
|
Weeks 13 to 24
Adverse Event
|
0
|
3
|
|
Weeks 13 to 24
Withdrawal by Subject
|
2
|
1
|
|
Weeks 13 to 24
Disease progression
|
0
|
1
|
|
Weeks 13 to 24
Lost to Follow-up
|
1
|
2
|
|
Weeks 13 to 24
Other
|
0
|
1
|
Baseline Characteristics
Moderate to Severe Plaque Psoriasis With Scalp Involvement
Baseline characteristics by cohort
| Measure |
Placebo BIW/Etanercept 50 mg BIW
n=62 Participants
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
n=62 Participants
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
42.68 years
STANDARD_DEVIATION 13.79 • n=5 Participants
|
41.55 years
STANDARD_DEVIATION 13.93 • n=7 Participants
|
42.11 years
STANDARD_DEVIATION 13.81 • n=5 Participants
|
|
Race/Ethnicity, Customized
Aborigine
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body Mass Index Group
≤ 35 kg/m^2
|
46 participants
n=5 Participants
|
44 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Body Mass Index Group
> 35 kg/m^2
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intention-to-Treat population (all patients who were randomized to investigational product) with available data; last observation carried forward (LOCF) imputation was used.
The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.
Outcome measures
| Measure |
Placebo BIW/Etanercept 50 mg BIW
n=61 Participants
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
n=59 Participants
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
|---|---|---|
|
Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12
|
20.4 Percent change
Standard Error 5.0
|
86.8 Percent change
Standard Error 2.3
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation
Percentage of participants achieving at least a 75% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) at Week 12. The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area. PSSI 75 indicates at least a 75% improvement in the PSSI score from baseline.
Outcome measures
| Measure |
Placebo BIW/Etanercept 50 mg BIW
n=61 Participants
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
n=59 Participants
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
|---|---|---|
|
Percentage of Participants With PSSI 75% Response at Week 12
|
11 Percentage of participants
|
86 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation.
Percent change from baseline in Psoriasis Scalp Severity Index (PSSI) in participants switching from placebo to etanercept at Week 12 (Group B) at Week 24. The PSSI measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicate more severe disease. The PSSI calculation does not include the face or neck area.
Outcome measures
| Measure |
Placebo BIW/Etanercept 50 mg BIW
n=61 Participants
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
|---|---|---|
|
Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12
|
79.1 Percent change
Standard Error 4.3
|
—
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Intention-to-Treat with available data at week 12; last observation carried forward (LOCF) imputation was used.
This response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey. To assess satisfaction with treatment, the participant was asked to check a box (from "very dissatisfied" to "very satisfied") to indicate his or her level of satisfaction with the medication's control of psoriasis.
Outcome measures
| Measure |
Placebo BIW/Etanercept 50 mg BIW
n=59 Participants
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
n=58 Participants
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
|---|---|---|
|
Patient Satisfaction With Treatment at Week 12
Very dissatisfied
|
15 participants
|
9 participants
|
|
Patient Satisfaction With Treatment at Week 12
Dissatisfied
|
20 participants
|
1 participants
|
|
Patient Satisfaction With Treatment at Week 12
Neither satisfied nor dissatisfied
|
13 participants
|
4 participants
|
|
Patient Satisfaction With Treatment at Week 12
Satisfied
|
5 participants
|
17 participants
|
|
Patient Satisfaction With Treatment at Week 12
Very satisfied
|
6 participants
|
27 participants
|
Adverse Events
Placebo BIW/Etanercept 50 mg BIW
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Etanercept 50 mg BIW/Etanercept 50 mg QW
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo BIW/Etanercept 50 mg BIW
n=62 participants at risk
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
n=59 participants at risk
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
|---|---|---|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
1/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
1/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
FALL
|
1.6%
1/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
1.6%
1/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC MALIGNANT MELANOMA
|
0.00%
0/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
1.7%
1/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Placebo BIW/Etanercept 50 mg BIW
n=62 participants at risk
Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
|
Etanercept 50 mg BIW/Etanercept 50 mg QW
n=59 participants at risk
Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
|
|---|---|---|
|
General disorders
INJECTION SITE REACTION
|
4.8%
3/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.8%
4/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
BRONCHITIS
|
3.2%
2/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.1%
3/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
EAR INFECTION
|
6.5%
4/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.1%
5/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.5%
5/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
SINUSITIS
|
1.6%
1/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.1%
3/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
14.5%
9/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.5%
5/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
3.2%
2/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.8%
4/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
HEADACHE
|
3.2%
2/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
6.8%
4/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
HYPERTENSION
|
1.6%
1/62 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.1%
3/59 • First dose to last dose +30 days (up to 28 weeks)
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER