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The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis.
This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Experimental | Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study | Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA). | Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24 | Week 24 | |
| Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12 | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Mobile | Alabama | 36608 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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This study was conducted at 39 centers in North America (United States and Canada). The first participant enrolled on 29 January 2015 and the last participant was enrolled on 08 May 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24 | Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept. | Week 24 |
| Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12 | Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept. | Week 12 |
| Bakersfield |
| California |
| 93309 |
| United States |
| Research Site | Beverly Hills | California | 90212 | United States |
| Research Site | Fremont | California | 94538 | United States |
| Research Site | Los Angeles | California | 90036 | United States |
| Research Site | Denver | Colorado | 80210 | United States |
| Research Site | Denver | Colorado | 80220 | United States |
| Research Site | Aventura | Florida | 33180 | United States |
| Research Site | Miami | Florida | 33144 | United States |
| Research Site | Pembroke Pines | Florida | 33028 | United States |
| Research Site | Carmel | Indiana | 46032 | United States |
| Research Site | Indianapolis | Indiana | 46256 | United States |
| Research Site | New Albany | Indiana | 47150 | United States |
| Research Site | Overland Park | Kansas | 66202 | United States |
| Research Site | Overland Park | Kansas | 66215 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Owensboro | Kentucky | 42303 | United States |
| Research Site | Rockville | Maryland | 20850 | United States |
| Research Site | Andover | Massachusetts | 01810 | United States |
| Research Site | Worcester | Massachusetts | 01605 | United States |
| Research Site | Clarkston | Michigan | 48346 | United States |
| Research Site | Omaha | Nebraska | 68144 | United States |
| Research Site | Verona | New Jersey | 07044 | United States |
| Research Site | Raleigh | North Carolina | 27612 | United States |
| Research Site | Cincinnati | Ohio | 45249 | United States |
| Research Site | Johnston | Rhode Island | 02919 | United States |
| Research Site | Nashville | Tennessee | 37205 | United States |
| Research Site | Bellaire | Texas | 77401 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | San Antonio | Texas | 78249 | United States |
| Research Site | Norfolk | Virginia | 23507 | United States |
| Research Site | Surrey | British Columbia | V3R 6A7 | Canada |
| Research Site | Bathurst | New Brunswick | E2A 4Z9 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1A 4Y3 | Canada |
| Research Site | Barrie | Ontario | L4M 7G1 | Canada |
| Research Site | Courtice | Ontario | L1E 3C3 | Canada |
| Research Site | Greater Sudbury | Ontario | P3C 1X8 | Canada |
| Research Site | Kingston | Ontario | K7L 1S2 | Canada |
| Research Site | Markham | Ontario | L3P 1X2 | Canada |
| Research Site | Oakville | Ontario | L6J 7W5 | Canada |
| Research Site | Toronto | Ontario | M5S 3B4 | Canada |
| Research Site | Toronto | Ontario | M8X 1Y9 | Canada |
| Research Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Safety analysis set (all enrolled participants who received ≥ 1 dose of investigational product during the study)
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Gender | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Duration of Psoriasis | Mean | Standard Deviation | years |
|
| 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 of Participants With Positive Anti-etanercept Binding Antibody Response During the Study | Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA). | Primary Antibody Analysis Set included all enrolled participants who received ≥ 1 dose of investigational product and had both a baseline and ≥ 1 post-baseline serum obtained for anti-etanercept antibody assessment, excluding participants with a negative antibody response at week 12 and missing antibody assessment at week 24. | Posted | Number | 95% Confidence Interval | percentage of participants | Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24. |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24 | Participants with available antibody response data at week 24 | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12 | Participants with available antibody response data at week 12 | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24 | Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept. | Participants with a positive anti-etanercept antibody binding response at week 24 | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12 | Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept. | Participants with a positive anti-etanercept antibody binding response at week 12 | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
|
|
From the first dose of investigational product through 30 days after last dose; 28 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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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 | Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks. | 5 | 131 | 24 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal wall infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | 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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| 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 |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Title | Denominators | Categories |
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