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| ID | Type | Description | Link |
|---|---|---|---|
| CA-2009-0004 |
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to adalimumab and infliximab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Experimental | All patients will receive etanercept 50 mg twice a week for 12 weeks followed by 50 mg once a week for an additional 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept 50 mg | Drug | All patients will receive etanercept 50 mg twice a week for 12 weeks followed by 50 mg once a week for an additional 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who reach a Physician's Global Assessment (PGA) of clear or almost clear after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg every other week (EOW). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who reach a PGA of clear or almost clear after 12 and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW. | 24 weeks | |
| Proportion of patients who reach a PGA of clear or almost clear after 12 and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald B Vender, MD | Dermatrials Research | Principal Investigator |
| Robert Bissonnette, MD | Innovaderm Research Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirk Barber Research | Calgary | Alberta | T2S3B3 | Canada | ||
| PerCuro Clinical Research Ltd |
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| 24 weeks |
| Mean Body Surface Area (BSA) after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab. | 24 weeks |
| Mean BSA after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW. | 24 weeks |
| Mean BSA after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW. | 24 weeks |
| Mean Psoriasis Area and Severity Index (PASI) score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to infliximab. | 24 weeks |
| Mean PASI score after 12 weeks and 24 weeks of etanercept for patients who have lost their satisfactory response to adalimumab 40 mg EOW. | 24 weeks |
| Mean PASI score after 12 and 24 weeks of etanercept for patients who have shown an unsatisfactory response to adalimumab 40 mg EOW. | 24 weeks |
| Safety of etanercept in patients who have shown an unsatisfactory response to adalimumab, who have lost their satisfactory response to adalimumab or who have lost their satisfactory response to infliximab. | 24 weeks |
| Victoria |
| British Columbia |
| V8V 3P9 |
| Canada |
| Winnipeg Clinic Dermatology Research | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| New Lab Clinical Research | St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| Eastern Canada Cutaneous Research Associates Ltd | Halifax | Nova Scotia | B3H 1Z4 | Canada |
| Sudbury Skin Clinic | Greater Sudbury | Ontario | P3E 5M4 | Canada |
| Dermatrials Research | Hamilton | Ontario | L8N 1V6 | Canada |
| Mediprobe Research Inc. | London | Ontario | N5X 2P1 | Canada |
| Lynderm research Inc. | Markham | Ontario | L3P 1A8 | Canada |
| Dermatology Associates | North York | Ontario | M4A 2V6 | Canada |
| Dr. Jay Brian Taradash | Toronto | Ontario | M4V 1R1 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2K 4L5 | Canada |
| Siena Medical Research | Montreal | Quebec | H3A 1A1 | Canada |
| Centre de Recherches Dermatologiques du Quebec Metropolitain | Québec | Quebec | G1V 4X7 | Canada |
| Clinique Esthetique Dr Isabelle Delorme | Saint-Hyacinthe | Quebec | J2S 6L6 | Canada |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| 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 |
| 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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