Trial Outcomes & Findings for Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis (NCT NCT00332332)
NCT ID: NCT00332332
Last Updated: 2014-07-25
Results Overview
The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.
COMPLETED
PHASE4
246 participants
Month 12
2014-07-25
Participant Flow
Participants were enrolled from 17 March 2006 through 30 June 2008
Participant milestones
| Measure |
Etanercept
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Overall Study
STARTED
|
246
|
|
Overall Study
Received Study Medication
|
230
|
|
Overall Study
COMPLETED
|
178
|
|
Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
| Measure |
Etanercept
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Protocol deviation
|
4
|
|
Overall Study
Noncompliance
|
2
|
|
Overall Study
Disease progression
|
2
|
|
Overall Study
Other
|
18
|
|
Overall Study
Did not receive study treatment
|
16
|
Baseline Characteristics
Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis
Baseline characteristics by cohort
| Measure |
Etanercept
n=230 Participants
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Age, Continuous
|
45.5 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
215 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aborigine
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Patient Global Assessment
|
4.0 Units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Body Surface Area
|
27.4 m^2
STANDARD_DEVIATION 21.3 • n=5 Participants
|
|
Dermatology Quality of Life Index Total Score
|
13.7 Units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest. Missing post-baseline values were imputed using last observation carried forward.
The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.
Outcome measures
| Measure |
Etanercept
n=226 Participants
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Participants With a Status of Mild or Better on Physician Global Assessment at Month 12
|
166 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).
Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.
Outcome measures
| Measure |
Etanercept
n=223 Participants
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Percent Change From Baseline to Month 12 in Patient Global Assessment
|
-57.9 Percent change
Interval -62.6 to -53.2
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).
Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.
Outcome measures
| Measure |
Etanercept
n=226 Participants
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis
|
-69.9 Percent change
Interval -75.1 to -64.6
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).
Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Etanercept
n=225 Participants
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score
|
-68.2 Percent change
Interval -73.7 to -62.8
|
Adverse Events
Etanercept
Serious adverse events
| Measure |
Etanercept
n=230 participants at risk
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Cardiac disorders
Atrial flutter
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
General disorders
Death
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Cellulitis
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Sepsis
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.43%
1/230 • Up to 13 months
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)
Basal cell carcinoma
|
0.43%
1/230 • Up to 13 months
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)
Squamous cell carcinoma
|
0.43%
1/230 • Up to 13 months
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)
Thyroid adenoma
|
0.43%
1/230 • Up to 13 months
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)
Thyroid gland cancer
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Convulsion
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Aortic stenosis
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
0.43%
1/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Etanercept
n=230 participants at risk
Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.8%
18/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
16/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
7.0%
16/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.7%
13/230 • Up to 13 months
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. 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