Moderate to Severe Plaque Psoriasis Clinical Trial
Official title:
A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874
The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.
| Status | Completed |
| Enrollment | 2301 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Having participated in a preceding ABT-874 clinical trial for ABT-874 - Subject has a clinical diagnosis of moderate to severe plaque psoriasis Exclusion Criteria: - Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Site Reference ID/Investigator# 16845 | Graz | |
| Austria | Site Reference ID/Investigator# 18183 | Vienna | |
| Belgium | Site Reference ID/Investigator# 15761 | Brussels | |
| Canada | Site Reference ID/Investigator# 7991 | Barrie | |
| Canada | Site Reference ID/Investigator# 8047 | Calgary | |
| Canada | Site Reference ID/Investigator# 7996 | Edmonton | |
| Canada | Site Reference ID/Investigator# 6996 | Halifax | |
| Canada | Site Reference ID/Investigator# 7236 | Hamilton | |
| Canada | Site Reference ID/Investigator# 6995 | Laval | |
| Canada | Site Reference ID/Investigator# 6998 | London | |
| Canada | Site Reference ID/Investigator# 7043 | London | |
| Canada | Site Reference ID/Investigator# 7329 | Markham | |
| Canada | Site Reference ID/Investigator# 6999 | Montreal | |
| Canada | Site Reference ID/Investigator# 7652 | Montreal | |
| Canada | Site Reference ID/Investigator# 7006 | North Bay | |
| Canada | Site Reference ID/Investigator# 8102 | Ottawa | |
| Canada | Site Reference ID/Investigator# 6993 | Quebec City | |
| Canada | Site Reference ID/Investigator# 8112 | St. John's | |
| Canada | Site Reference ID/Investigator# 7931 | Surrey | |
| Canada | Site Reference ID/Investigator# 6997 | Vancouver | |
| Canada | Site Reference ID/Investigator# 8118 | Vancouver | |
| Canada | Site Reference ID/Investigator# 6994 | Waterloo | |
| Canada | Site Reference ID/Investigator# 8111 | Westmount | |
| Canada | Site Reference ID/Investigator# 7005 | Windsor | |
| Canada | Site Reference ID/Investigator# 7979 | Windsor | |
| Canada | Site Reference ID/Investigator# 8348 | Winnipeg | |
| Denmark | Site Reference ID/Investigator# 17781 | Aarhus | |
| Denmark | Site Reference ID/Investigator# 18041 | Copenhagen NV | |
| Finland | Site Reference ID/Investigator# 18661 | Helsinki | |
| Finland | Site Reference ID/Investigator# 18701 | Kuopio | |
| Finland | Site Reference ID/Investigator# 14962 | Lahti | |
| Finland | Site Reference ID/Investigator# 19241 | Turku | |
| France | Site Reference ID/Investigator# 18502 | Nice | |
| France | Site Reference ID/Investigator# 16781 | Paris Cedex 10 | |
| France | Site Reference ID/Investigator# 18506 | Toulouse, Cedex 9 | |
| Germany | Site Reference ID/Investigator# 16281 | Berlin | |
| Germany | Site Reference ID/Investigator# 15664 | Frankfurt am Main | |
| Germany | Site Reference ID/Investigator# 15663 | Hamburg | |
| Germany | Site Reference ID/Investigator# 16381 | Kiel | |
| Germany | Site Reference ID/Investigator# 16161 | Muenster | |
| Germany | Site Reference ID/Investigator# 16143 | Munich | |
| Germany | Site Reference ID/Investigator# 17676 | Tuebingen | |
| Greece | Site Reference ID/Investigator# 15921 | Athens | |
| Greece | Site Reference ID/Investigator# 16282 | Athens | |
| Greece | Site Reference ID/Investigator# 15922 | Thessaloniki | |
| Italy | Site Reference ID/Investigator# 15401 | Modena | |
| Italy | Site Reference ID/Investigator# 14881 | Rome | |
| Spain | Site Reference ID/Investigator# 19322 | Barcelona | |
| Spain | Site Reference ID/Investigator# 15341 | Madrid | |
| Sweden | Site Reference ID/Investigator# 16142 | Stockholm | |
| Switzerland | Site Reference ID/Investigator# 17721 | Geneva 14 | |
| Switzerland | Site Reference ID/Investigator# 16749 | Zurich | |
| United Kingdom | Site Reference ID/Investigator# 19045 | Aberdeen | |
| United Kingdom | Site Reference ID/Investigator# 15422 | Manchester | |
| United States | Site Reference ID/Investigator# 7455 | Albuquerque | New Mexico |
| United States | Site Reference ID/Investigator# 7331 | Alpharetta | Georgia |
| United States | Site Reference ID/Investigator# 8529 | Andover | Massachusetts |
| United States | Site Reference ID/Investigator# 7684 | Arlington | Texas |
| United States | Site Reference ID/Investigator# 8379 | Arlington Heights | Illinois |
| United States | Site Reference ID/Investigator# 9743 | Atlanta | Georgia |
| United States | Site Reference ID/Investigator# 10842 | Austin | Texas |
| United States | Site Reference ID/Investigator# 7234 | Bakersfield | California |
| United States | Site Reference ID/Investigator# 7757 | Berlin | New Jersey |
| United States | Site Reference ID/Investigator# 7496 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 8438 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 8149 | Boston | Massachusetts |
| United States | Site Reference ID/Investigator# 8078 | Buffalo | New York |
| United States | Site Reference ID/Investigator# 23345 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 6945 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 7044 | Cleveland | Ohio |
| United States | Site Reference ID/Investigator# 7899 | Columbus | Ohio |
| United States | Site Reference ID/Investigator# 6947 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 7498 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 8389 | Dayton | Ohio |
| United States | Site Reference ID/Investigator# 7929 | Denver | Colorado |
| United States | Site Reference ID/Investigator# 9823 | Detroit | Michigan |
| United States | Site Reference ID/Investigator# 7653 | Doral | Florida |
| United States | Site Reference ID/Investigator# 7330 | East Windsor | New Jersey |
| United States | Site Reference ID/Investigator# 7883 | Fort Gratiot | Michigan |
| United States | Site Reference ID/Investigator# 8249 | Fresno | California |
| United States | Site Reference ID/Investigator# 7656 | Fridley | Minnesota |
| United States | Site Reference ID/Investigator# 7497 | Goodlettsville | Tennessee |
| United States | Site Reference ID/Investigator# 7238 | Grand Blanc | Michigan |
| United States | Site Reference ID/Investigator# 7785 | Greer | South Carolina |
| United States | Site Reference ID/Investigator# 17193 | Henderson | Kentucky |
| United States | Site Reference ID/Investigator# 8494 | Hershey | Pennsylvania |
| United States | Site Reference ID/Investigator# 7434 | Hickory | North Carolina |
| United States | Site Reference ID/Investigator# 6944 | Houston | Texas |
| United States | Site Reference ID/Investigator# 7522 | Huntsville | Alabama |
| United States | Site Reference ID/Investigator# 10422 | Indianapolis | Indiana |
| United States | Site Reference ID/Investigator# 6933 | Indianapolis | Indiana |
| United States | Site Reference ID/Investigator# 7332 | Irvine | California |
| United States | Site Reference ID/Investigator# 8341 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 6934 | Johnston | Rhode Island |
| United States | Site Reference ID/Investigator# 7388 | Knoxville | Tennessee |
| United States | Site Reference ID/Investigator# 6936 | Lake Oswego | Oregon |
| United States | Site Reference ID/Investigator# 7933 | Little Rock | Arkansas |
| United States | Site Reference ID/Investigator# 7436 | Longmont | Colorado |
| United States | Site Reference ID/Investigator# 7239 | Los Angeles | California |
| United States | Site Reference ID/Investigator# 8528 | Louisville | Kentucky |
| United States | Site Reference ID/Investigator# 8798 | Maywood | Illinois |
| United States | Site Reference ID/Investigator# 7657 | Miami | Florida |
| United States | Site Reference ID/Investigator# 7716 | Miami | Florida |
| United States | Site Reference ID/Investigator# 7884 | Milwaukee | Wisconsin |
| United States | Site Reference ID/Investigator# 6931 | Nashville | Tennessee |
| United States | Site Reference ID/Investigator# 7882 | New Brunswick | New Jersey |
| United States | Site Reference ID/Investigator# 7521 | New Haven | Connecticut |
| United States | Site Reference ID/Investigator# 10201 | New York | New York |
| United States | Site Reference ID/Investigator# 7230 | New York | New York |
| United States | Site Reference ID/Investigator# 8006 | New York | New York |
| United States | Site Reference ID/Investigator# 8392 | New York | New York |
| United States | Site Reference ID/Investigator# 7891 | Newnan | Georgia |
| United States | Site Reference ID/Investigator# 6946 | Norfolk | Virginia |
| United States | Site Reference ID/Investigator# 8390 | Oceanside | California |
| United States | Site Reference ID/Investigator# 11181 | Oklahoma City | Oklahoma |
| United States | Site Reference ID/Investigator# 7240 | Omaha | Nebraska |
| United States | Site Reference ID/Investigator# 9567 | Omaha | Nebraska |
| United States | Site Reference ID/Investigator# 7992 | Overland Park | Kansas |
| United States | Site Reference ID/Investigator# 9962 | Owensboro | Kentucky |
| United States | Site Reference ID/Investigator# 7930 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 16581 | Plainfield | Indiana |
| United States | Site Reference ID/Investigator# 11424 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 6948 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 7703 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 6935 | Providence | Rhode Island |
| United States | Site Reference ID/Investigator# 8037 | Rochester | New York |
| United States | Site Reference ID/Investigator# 10207 | Salt Lake City | Utah |
| United States | Site Reference ID/Investigator# 7758 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 8108 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 7010 | San Diego | California |
| United States | Site Reference ID/Investigator# 7503 | San Diego | California |
| United States | Site Reference ID/Investigator# 7520 | San Diego | California |
| United States | Site Reference ID/Investigator# 10962 | San Francisco | California |
| United States | Site Reference ID/Investigator# 7334 | Santa Monica | California |
| United States | Site Reference ID/Investigator# 10703 | Schaumburg | Illinois |
| United States | Site Reference ID/Investigator# 7774 | Scottsdale | Arizona |
| United States | Site Reference ID/Investigator# 6932 | Seattle | Washington |
| United States | Site Reference ID/Investigator# 6950 | Skokie | Illinois |
| United States | Site Reference ID/Investigator# 7932 | Snellville | Georgia |
| United States | Site Reference ID/Investigator# 10841 | South Miami | Florida |
| United States | Site Reference ID/Investigator# 10306 | Spokane | Washington |
| United States | Site Reference ID/Investigator# 6930 | St. Louis | Missouri |
| United States | Site Reference ID/Investigator# 6949 | St. Louis | Missouri |
| United States | Site Reference ID/Investigator# 7333 | Stoney Brook | New York |
| United States | Site Reference ID/Investigator# 7435 | Tucson | Arizona |
| United States | Site Reference ID/Investigator# 6937 | Tyler | Texas |
| United States | Site Reference ID/Investigator# 7793 | Vallejo | California |
| United States | Site Reference ID/Investigator# 7655 | Webster | Texas |
| United States | Site Reference ID/Investigator# 7892 | West Dundee | Illinois |
| United States | Site Reference ID/Investigator# 7893 | West Palm Beach | Florida |
| United States | Site Reference ID/Investigator# 8117 | Wilmington | North Carolina |
| United States | Site Reference ID/Investigator# 9681 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
United States, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Spain, Sweden, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit. | Visit (12 weeks) | No | |
| Primary | Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit. | Visit (12 weeks) | No | |
| Primary | Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit. | Visit (12 weeks) | No | |
| Primary | AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study | Visit (12 weeks) | Yes |
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