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The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo BIW/Etanercept 50 mg BIW | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Biological | Etanercept for subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Psoriasis Scalp Severity Index 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With PSSI 75% Response at Week 12 | 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. |
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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 |
|---|---|---|---|
| 22014541 | Background | Bagel J, Lynde C, Tyring S, Kricorian G, Shi Y, Klekotka P. Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. J Am Acad Dermatol. 2012 Jul;67(1):86-92. doi: 10.1016/j.jaad.2011.07.034. Epub 2011 Oct 20. | |
| 22188302 | Background | Tyring S, Bagel J, Lynde C, Klekotka P, Thompson EH, Gandra SR, Shi Y, Kricorian G. Patient-reported outcomes in moderate-to-severe plaque psoriasis with scalp involvement: results from a randomized, double-blind, placebo-controlled study of etanercept. J Eur Acad Dermatol Venereol. 2013 Jan;27(1):125-8. doi: 10.1111/j.1468-3083.2011.04394.x. Epub 2011 Dec 21. No abstract available. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 5 December 2008 through 6 January 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Weeks 1 to 12 |
|
| ||||||||||||||||||||||||
| Weeks 13 to 24 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Etanercept 50 mg BIW/Etanercept 50 mg QW |
| 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 | Percentage Change From Baseline in Psoriasis Scalp Severity Index 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. | Intention-to-Treat population (all patients who were randomized to investigational product) with available data; last observation carried forward (LOCF) imputation was used. | Posted | Mean | Standard Error | Percent change | Baseline and Week 12 |
|
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.
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INJECTION SITE REACTION | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Placebo | Biological | Placebo for subcutaneous injection. |
|
| Baseline and Week 12 |
| Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12 | 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. | Baseline and Week 24 |
| Patient Satisfaction With Treatment at Week 12 | 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. | 12 Weeks |
| Withdrawal by Subject |
|
| Physician Decision |
|
| Disease progression |
|
| Ineligibility determined |
|
| NOT COMPLETED |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Body Mass Index Group | Number | participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Percentage of Participants With PSSI 75% Response at Week 12 | 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. | Intention-to-Treat with available data; last observation carried forward (LOCF) imputation | Posted | Number | Percentage of participants | Baseline and Week 12 |
|
|
|
|
| Secondary | Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12 | 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. | Intention-to-Treat with available data; last observation carried forward (LOCF) imputation. | Posted | Mean | Standard Error | Percent change | Baseline and Week 24 |
|
|
|
|
| Secondary | Patient Satisfaction With Treatment at Week 12 | 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. | Intention-to-Treat with available data at week 12; last observation carried forward (LOCF) imputation was used. | Posted | Number | participants | 12 Weeks |
|
|
|
|
| 1 |
| 62 |
| 25 |
| 62 |
| EG001 | 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. | 2 | 59 | 27 | 59 |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| EAR INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
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.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Neither satisfied nor dissatisfied |
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| Satisfied |
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| Very satisfied |
|