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Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Drug | OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index | Week 12-Week 24 | |
| Adverse Events | Throughout Study Participation |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area and Severity Index | Week 12, Week 24 through 360 days after last dose | |
| Physician's Global Assessment | Week 12, Week 24 through 360 days after last dose |
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Exclusion Criteria:
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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 |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| placebo for adalimumab | Drug | OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |