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Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy
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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 | 40 mg adalimumab eow Week 0 - Week 12 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 | Week 12 | |
| Adverse Events | Throughout the Study |
| Measure | Description | Time Frame |
|---|---|---|
| ACR50/70 | Week 12 | |
| Modified Psoriatic Arthritis Response Criteria | Week 12 | |
| Multiple QOL Assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| placebo for adalimumab | Drug | placebo eow Week 0 - Week 12 |
|
|
| Week 12 |
| Physicians Global Assessment for Psoriasis | Week 12 |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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