Clinical trial NCT00626002: Open Label Continuation Study in Moderate to Severe Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: Open label
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 2301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe psoriasis.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.
timeFrame: Visit (12 weeks)
measure: 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.
timeFrame: Visit (12 weeks)
measure: 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.
timeFrame: Visit (12 weeks)
measure: AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study
timeFrame: Visit (12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 7496
state: Alabama
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 8438
state: Alabama
city: Huntsville
country: United States
facility: Site Reference ID/Investigator# 7522
state: Alabama
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 7774
state: Arizona
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 7435
state: Arizona
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 7933
state: Arkansas
city: Bakersfield
country: United States
facility: Site Reference ID/Investigator# 7234
state: California
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 8249
state: California
city: Irvine
country: United States
facility: Site Reference ID/Investigator# 7332
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 7239
state: California
city: Oceanside
country: United States
facility: Site Reference ID/Investigator# 8390
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 7503
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 7520
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 7010
state: California
city: San Francisco
country: United States
facility: Site Reference ID/Investigator# 10962
state: California
city: Santa Monica
country: United States
facility: Site Reference ID/Investigator# 7334
state: California
city: Vallejo
country: United States
facility: Site Reference ID/Investigator# 7793
state: California
city: Denver
country: United States
facility: Site Reference ID/Investigator# 7929
state: Colorado
city: Longmont
country: United States
facility: Site Reference ID/Investigator# 7436
state: Colorado
city: New Haven
country: United States
facility: Site Reference ID/Investigator# 7521
state: Connecticut
city: Doral
country: United States
facility: Site Reference ID/Investigator# 7653
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 8341
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 7716
state: Florida
city: Miami
country: United States
facility: Site Reference ID/Investigator# 7657
state: Florida
city: South Miami
country: United States
facility: Site Reference ID/Investigator# 10841
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 7893
state: Florida
city: Alpharetta
country: United States
facility: Site Reference ID/Investigator# 7331
state: Georgia
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 9743
state: Georgia
city: Newnan
country: United States
facility: Site Reference ID/Investigator# 7891
state: Georgia
city: Snellville
country: United States
facility: Site Reference ID/Investigator# 7932
state: Georgia
city: Arlington Heights
country: United States
facility: Site Reference ID/Investigator# 8379
state: Illinois
city: Maywood
country: United States
facility: Site Reference ID/Investigator# 8798
state: Illinois
city: Schaumburg
country: United States
facility: Site Reference ID/Investigator# 10703
state: Illinois
city: Skokie
country: United States
facility: Site Reference ID/Investigator# 6950
state: Illinois
city: West Dundee
country: United States
facility: Site Reference ID/Investigator# 7892
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 6933
state: Indiana
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 10422
state: Indiana
city: Plainfield
country: United States
facility: Site Reference ID/Investigator# 16581
state: Indiana
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 7992
state: Kansas
city: Henderson
country: United States
facility: Site Reference ID/Investigator# 17193
state: Kentucky
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 8528
state: Kentucky
city: Owensboro
country: United States
facility: Site Reference ID/Investigator# 9962
state: Kentucky
city: Andover
country: United States
facility: Site Reference ID/Investigator# 8529
state: Massachusetts
city: Boston
country: United States
facility: Site Reference ID/Investigator# 8149
state: Massachusetts
city: Detroit
country: United States
facility: Site Reference ID/Investigator# 9823
state: Michigan
city: Fort Gratiot
country: United States
facility: Site Reference ID/Investigator# 7883
state: Michigan
city: Grand Blanc
country: United States
facility: Site Reference ID/Investigator# 7238
state: Michigan
city: Fridley
country: United States
facility: Site Reference ID/Investigator# 7656
state: Minnesota
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 6930
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 6949
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 7240
state: Nebraska
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 9567
state: Nebraska
city: Berlin
country: United States
facility: Site Reference ID/Investigator# 7757
state: New Jersey
city: East Windsor
country: United States
facility: Site Reference ID/Investigator# 7330
state: New Jersey
city: New Brunswick
country: United States
facility: Site Reference ID/Investigator# 7882
state: New Jersey
city: Albuquerque
country: United States
facility: Site Reference ID/Investigator# 7455
state: New Mexico
city: Buffalo
country: United States
facility: Site Reference ID/Investigator# 8078
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 8392
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 8006
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 7230
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 10201
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 8037
state: New York
city: Stoney Brook
country: United States
facility: Site Reference ID/Investigator# 7333
state: New York
city: Hickory
country: United States
facility: Site Reference ID/Investigator# 7434
state: North Carolina
city: Wilmington
country: United States
facility: Site Reference ID/Investigator# 8117
state: North Carolina
city: Winston-Salem
country: United States
facility: Site Reference ID/Investigator# 9681
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 6945
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 23345
state: Ohio
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 7044
state: Ohio
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 7899
state: Ohio
city: Dayton
country: United States
facility: Site Reference ID/Investigator# 8389
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 11181
state: Oklahoma
city: Lake Oswego
country: United States
facility: Site Reference ID/Investigator# 6936
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 7703
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 6948
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 11424
state: Oregon
city: Hershey
country: United States
facility: Site Reference ID/Investigator# 8494
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 7930
state: Pennsylvania
city: Johnston
country: United States
facility: Site Reference ID/Investigator# 6934
state: Rhode Island
city: Providence
country: United States
facility: Site Reference ID/Investigator# 6935
state: Rhode Island
city: Greer
country: United States
facility: Site Reference ID/Investigator# 7785
state: South Carolina
city: Goodlettsville
country: United States
facility: Site Reference ID/Investigator# 7497
state: Tennessee
city: Knoxville
country: United States
facility: Site Reference ID/Investigator# 7388
state: Tennessee
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 6931
state: Tennessee
city: Arlington
country: United States
facility: Site Reference ID/Investigator# 7684
state: Texas
city: Austin
country: United States
facility: Site Reference ID/Investigator# 10842
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 7498
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 6947
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 6944
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7758
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 8108
state: Texas
city: Tyler
country: United States
facility: Site Reference ID/Investigator# 6937
state: Texas
city: Webster
country: United States
facility: Site Reference ID/Investigator# 7655
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 10207
state: Utah
city: Norfolk
country: United States
facility: Site Reference ID/Investigator# 6946
state: Virginia
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 6932
state: Washington
city: Spokane
country: United States
facility: Site Reference ID/Investigator# 10306
state: Washington
city: Milwaukee
country: United States
facility: Site Reference ID/Investigator# 7884
state: Wisconsin
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 16845
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 18183
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 15761
city: Barrie
country: Canada
facility: Site Reference ID/Investigator# 7991
city: Calgary
country: Canada
facility: Site Reference ID/Investigator# 8047
city: Edmonton
country: Canada
facility: Site Reference ID/Investigator# 7996
city: Halifax
country: Canada
facility: Site Reference ID/Investigator# 6996
city: Hamilton
country: Canada
facility: Site Reference ID/Investigator# 7236
city: Laval
country: Canada
facility: Site Reference ID/Investigator# 6995
city: London
country: Canada
facility: Site Reference ID/Investigator# 6998
city: London
country: Canada
facility: Site Reference ID/Investigator# 7043
city: Markham
country: Canada
facility: Site Reference ID/Investigator# 7329
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 6999
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 7652
city: North Bay
country: Canada
facility: Site Reference ID/Investigator# 7006
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 8102
city: Quebec City
country: Canada
facility: Site Reference ID/Investigator# 6993
city: St. John's
country: Canada
facility: Site Reference ID/Investigator# 8112
city: Surrey
country: Canada
facility: Site Reference ID/Investigator# 7931
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 8118
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 6997
city: Waterloo
country: Canada
facility: Site Reference ID/Investigator# 6994
city: Westmount
country: Canada
facility: Site Reference ID/Investigator# 8111
city: Windsor
country: Canada
facility: Site Reference ID/Investigator# 7005
city: Windsor
country: Canada
facility: Site Reference ID/Investigator# 7979
city: Winnipeg
country: Canada
facility: Site Reference ID/Investigator# 8348
city: Aarhus
country: Denmark
facility: Site Reference ID/Investigator# 17781
city: Copenhagen NV
country: Denmark
facility: Site Reference ID/Investigator# 18041
city: Helsinki
country: Finland
facility: Site Reference ID/Investigator# 18661
city: Kuopio
country: Finland
facility: Site Reference ID/Investigator# 18701
city: Lahti
country: Finland
facility: Site Reference ID/Investigator# 14962
city: Turku
country: Finland
facility: Site Reference ID/Investigator# 19241
city: Nice
country: France
facility: Site Reference ID/Investigator# 18502
city: Paris Cedex 10
country: France
facility: Site Reference ID/Investigator# 16781
city: Toulouse, Cedex 9
country: France
facility: Site Reference ID/Investigator# 18506
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 16281
city: Frankfurt am Main
country: Germany
facility: Site Reference ID/Investigator# 15664
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 15663
city: Kiel
country: Germany
facility: Site Reference ID/Investigator# 16381
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 16161
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 16143
city: Tuebingen
country: Germany
facility: Site Reference ID/Investigator# 17676
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 16282
city: Athens
country: Greece
facility: Site Reference ID/Investigator# 15921
city: Thessaloniki
country: Greece
facility: Site Reference ID/Investigator# 15922
city: Modena
country: Italy
facility: Site Reference ID/Investigator# 15401
city: Rome
country: Italy
facility: Site Reference ID/Investigator# 14881
city: Barcelona
country: Spain
facility: Site Reference ID/Investigator# 19322
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 15341
city: Stockholm
country: Sweden
facility: Site Reference ID/Investigator# 16142
city: Geneva 14
country: Switzerland
facility: Site Reference ID/Investigator# 17721
city: Zurich
country: Switzerland
facility: Site Reference ID/Investigator# 16749
city: Aberdeen
country: United Kingdom
facility: Site Reference ID/Investigator# 19045
city: Manchester
country: United Kingdom
facility: Site Reference ID/Investigator# 15422
Study officials:
affiliation: AbbVie
name: Martin Kaul, MD
role: STUDY_CHAIR
References: