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| Name | Class |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etanercept and clobetasol | Experimental | Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24) |
|
| etanercept | Experimental | Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1=Etanercept | Drug | 50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PASI 75 at Week 12 | The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| sPGA (0,1) at Week 12 | The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23643256 | Background | Lebwohl MG, Kircik L, Callis Duffin K, Pariser D, Hooper M, Wenkert D, Thompson EH, Yang J, Kricorian G, Koo J. A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2013 Sep;69(3):385-92. doi: 10.1016/j.jaad.2013.03.031. Epub 2013 May 1. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 15 September 2010 through 17 October 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept Monotherapy | Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). |
| FG001 | Etanercept + Clobetasol Propionate Foam | Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept Monotherapy | Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). |
| BG001 | Etanercept + Clobetasol Propionate Foam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PASI 75 at Week 12 | The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline. | Intention-to-Treat with last observation carried forward (LOCF) imputation | Posted | Number | Percentage of participants | Week 12 |
|
28 weeks
The table of Other Adverse Events summarizes the most frequent non-serious adverse events that occurs in 5% participants or more in either arm.
The numbers of the participants at risk were summarized based on the actual treatment groups, which is different from the randomized treatment groups that were used in the efficacy analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept Monotherapy | Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 2=Clobetasol propionate foam |
| Drug |
0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses |
|
| PASI 90 at Week 12 | The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline. | Week 12 |
| Patient Satisfaction at Week 12 | Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied." | Week 12 |
| Percent PASI Improvement From Baseline at Week 12 | The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. | Week 12 |
| PASI 75 at Week 24 | The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline. | Week 24 |
| sPGA (0,1) at Week 24 | The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. | Week 24 |
| Pregnancy |
|
| Ineligibility determined |
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| Protocol Violation |
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| Adverse Event |
|
| Withdrawal by Subject |
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| Lack of Efficacy |
|
| Noncompliance |
|
| Administrative decision |
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| Other unspecified |
|
Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| BMI Categorical | Number | Participants |
|
| Psoriasis area severity index (PASI) | PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. | Mean | Standard Deviation | Scores on a scale |
|
| Psoriasis Body Surface Area(BSA) | Mean | Standard Deviation | % |
|
| Static physician global assessment of psoriasis (sPGA) | A physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. | Number | Participants |
|
| Patient global assessment of psoriasis | A 6-point scale rated by participants ranging from 0 (no symptoms) to 5 (severe symptoms) to indicate his or her symptom severity. | Number | Participants |
|
| Dermatology life quality index (DLQI) | A skin disease-specific instrument to evaluate health related quality of life ranging from 0 (best possible score) to 30 (worst possible score). | Mean | Standard Deviation |
|
| Patient assessment of treatment satisfaction | A measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied." | Number | Participants |
|
| Psoriatic arthritis | Number | Participants |
|
| Duration of psoriasis | Mean | Standard Deviation | Years |
|
Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas). |
|
|
|
| Secondary | sPGA (0,1) at Week 12 | The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. | Intention-to-Treat with last observation carried forward (LOCF) imputation | Posted | Number | Percentage of participants | Week 12 |
|
|
|
|
| Secondary | PASI 90 at Week 12 | The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline. | Intention-to-Treat with last observation carried forward (LOCF) imputation | Posted | Number | Percentage of participants | Week 12 |
|
|
|
|
| Secondary | Patient Satisfaction at Week 12 | Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied." | PRO analysis set, including all subjects randomized and also complete the baseline and at least 1 of the post-baseline PRO assessment with last observation carried forward (LOCF) imputation | Posted | Number | Percentage of participants | Week 12 |
|
|
|
|
| Secondary | Percent PASI Improvement From Baseline at Week 12 | The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. | Intention-to-Treat with last observation carried forward (LOCF) imputation | Posted | Mean | Standard Deviation | Percentage of Improvement in PASI score | Week 12 |
|
|
|
|
| Secondary | PASI 75 at Week 24 | The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline. | Intention-to-Treat with last observation carried forward (LOCF) imputation | Posted | Number | Percentage of participants | Week 24 |
|
|
|
|
| Secondary | sPGA (0,1) at Week 24 | The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. | Intention-to-Treat with last observation carried forward (LOCF) imputation | Posted | Number | Percentage of participants | Week 24 |
|
|
|
|
| 6 |
| 301 |
| 81 |
| 301 |
| EG001 | Etanercept + Clobetasol Propionate Foam | Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas). | 7 | 288 | 69 | 288 |
| Death | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Endometritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Tubo-ovarian abscess | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
| Neither satisfied nor dissatisfied |
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| Satisfied |
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| Very satisfied |
|