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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Biological | 50mgs subcutaneous injections twice a week for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12. | Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12 will measure efficacy of retreatment with etanercept | 12 weeks |
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Inclusion Criteria:
Tuberculosis inclusion criteria
Have no history of latent or active TB prior to screening.
Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
Have had no recent close contact with a person with active TB.
Within 1 month prior to the first administration of study have a negative tuberculin skin test.
Exclusion Criteria:
History of non-compliance with other therapies.
A two week wash out period is appropriate as it would be unethical to expect subjects whose disease if flaring to remain untreated for a longer period of time. The first dose of etanercept will be administered two weeks after the last biologic dose.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Academic Dermatology Center | Recruiting | Miami | Florida | 33136 | United States |
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| 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 |
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| 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 |