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The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks |
|
| 2 | Active Comparator | Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks |
|
| 3 | Active Comparator | Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks |
|
| 4 | Active Comparator | Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks |
|
| 5 | Active Comparator | Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks |
|
| 6 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti IL-12 monoclonal antibody/ABT-874 | Drug | Please see Arm Description for intervention description and details. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with clinical response relative to Baseline PASI score | Week 12, Week 40 and Week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Surveys | Week 12, Week 48 and Week 60 | |
| Clinical response indicators | Week 12, Week 48 and Week 60 | |
| Safety parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Kaul, MD | AbbVie | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 3351 | San Diego | California | 92123 | United States | ||
| Site Reference ID/Investigator# 3347 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18283176 | Derived | Kimball AB, Gordon KB, Langley RG, Menter A, Chartash EK, Valdes J; ABT-874 Psoriasis Study Investigators. Safety and efficacy of ABT-874, a fully human interleukin 12/23 monoclonal antibody, in the treatment of moderate to severe chronic plaque psoriasis: results of a randomized, placebo-controlled, phase 2 trial. Arch Dermatol. 2008 Feb;144(2):200-7. doi: 10.1001/archdermatol.2007.63. |
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placebo, 12 doses
|
| placebo | Drug | 12 doses |
|
| Monthly through duration of study |
| PGA Assessment | Week 12, Week 40 and Week 60 |
| Alpharetta |
| Georgia |
| 30022 |
| United States |
| Site Reference ID/Investigator# 3348 | Skokie | Illinois | 60077 | United States |
| Site Reference ID/Investigator# 993 | Indianapolis | Indiana | 46256 | United States |
| Site Reference ID/Investigator# 990 | Boston | Massachusetts | 02114 | United States |
| Site Reference ID/Investigator# 3349 | St Louis | Missouri | 63117 | United States |
| Site Reference ID/Investigator# 992 | Cincinnati | Ohio | 45219 | United States |
| Site Reference ID/Investigator# 991 | Lake Oswego | Oregon | 97035 | United States |
| Site Reference ID/Investigator# 3367 | Portland | Oregon | 97223 | United States |
| Site Reference ID/Investigator# 3346 | Johnston | Rhode Island | 02919 | United States |
| Site Reference ID/Investigator# 994 | Nashville | Tennessee | 37215 | United States |
| Site Reference ID/Investigator# 3350 | Dallas | Texas | 75246-1613 | United States |
| Site Reference ID/Investigator# 796 | Houston | Texas | 77030 | United States |
| Site Reference ID/Investigator# 2081 | Salt Lake City | Utah | 84132 | United States |
| Site Reference ID/Investigator# 3366 | Norfolk | Virginia | 23507 | United States |
| Site Reference ID/Investigator# 989 | Seattle | Washington | 98101 | United States |
| Site Reference ID/Investigator# 3361 | Halifax | B3H 1Z4 | Canada |
| Site Reference ID/Investigator# 985 | Laval | H7S 2C6 | Canada |
| Site Reference ID/Investigator# 987 | London | N5X 2P1 | Canada |
| Site Reference ID/Investigator# 3364 | Montreal | H2K 4L5 | Canada |
| Site Reference ID/Investigator# 794 | North Bay | P1B 3Z7 | Canada |
| Site Reference ID/Investigator# 988 | Québec | G1V 4X7 | Canada |
| Site Reference ID/Investigator# 795 | Waterloo | N2J 1C4 | Canada |
| Site Reference ID/Investigator# 3360 | Windsor | N8W 1E6 | Canada |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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