Open Label Continuation Study in Moderate to Severe Psoriasis

NCT00626002 | Completed Phase 3

• 2 other identifiers: M10-0162007-005955-40
• Study Type: interventional
• Target: 2,301
• Locations: 14 countries
• Sites: 152

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.

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Open label

Outcome Measures

Primary Outcomes (4)

• Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.

  Visit (12 weeks)

• 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)

• 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)

• AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study

  Visit (12 weeks)

Study Arms (1)

1

EXPERIMENTAL

Drug: ABT-874

Interventions

ABT-874 DRUG

100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks

Also known as: briakinumab

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having participated in a preceding ABT-874 clinical trial for ABT-874
• Subject has a clinical diagnosis of moderate to severe plaque psoriasis

You may not qualify if:

• Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (152)

Site Reference ID/Investigator# 7496

Birmingham, Alabama, 35205, United States

Location

Site Reference ID/Investigator# 8438

Birmingham, Alabama, 35233, United States

Location

Site Reference ID/Investigator# 7522

Huntsville, Alabama, 35801, United States

Location

Site Reference ID/Investigator# 7774

Scottsdale, Arizona, 85251, United States

Location

Site Reference ID/Investigator# 7435

Tucson, Arizona, 85710, United States

Location

Site Reference ID/Investigator# 7933

Little Rock, Arkansas, 72204, United States

Location

Site Reference ID/Investigator# 7234

Bakersfield, California, 93309, United States

Location

Site Reference ID/Investigator# 8249

Fresno, California, 93720, United States

Location

Site Reference ID/Investigator# 7332

Irvine, California, 92697, United States

Location

Site Reference ID/Investigator# 7239

Los Angeles, California, 90045, United States

Location

Site Reference ID/Investigator# 8390

Oceanside, California, 92056, United States

Location

Site Reference ID/Investigator# 7503

San Diego, California, 92103, United States

Location

Site Reference ID/Investigator# 7520

San Diego, California, 92117, United States

Location

Site Reference ID/Investigator# 7010

San Diego, California, 92123, United States

Location

Site Reference ID/Investigator# 10962

San Francisco, California, 94118, United States

Location

Site Reference ID/Investigator# 7334

Santa Monica, California, 90404, United States

Location

Site Reference ID/Investigator# 7793

Vallejo, California, 94589, United States

Location

Site Reference ID/Investigator# 7929

Denver, Colorado, 80209, United States

Location

Site Reference ID/Investigator# 7436

Longmont, Colorado, 80501, United States

Location

Site Reference ID/Investigator# 7521

New Haven, Connecticut, 06511, United States

Location

Site Reference ID/Investigator# 7653

Doral, Florida, 33166-6665, United States

Location

Site Reference ID/Investigator# 8341

Jacksonville, Florida, 32204, United States

Location

Site Reference ID/Investigator# 7716

Miami, Florida, 33136, United States

Location

Site Reference ID/Investigator# 7657

Miami, Florida, 33144, United States

Location

Site Reference ID/Investigator# 10841

South Miami, Florida, 33143, United States

Location

Site Reference ID/Investigator# 7893

West Palm Beach, Florida, 33409-3509, United States

Location

Site Reference ID/Investigator# 7331

Alpharetta, Georgia, 30022, United States

Location

Site Reference ID/Investigator# 9743

Atlanta, Georgia, 30327, United States

Location

Site Reference ID/Investigator# 7891

Newnan, Georgia, 30263, United States

Location

Site Reference ID/Investigator# 7932

Snellville, Georgia, 30078, United States

Location

Site Reference ID/Investigator# 8379

Arlington Heights, Illinois, 60005, United States

Location

Site Reference ID/Investigator# 8798

Maywood, Illinois, 60153, United States

Location

Site Reference ID/Investigator# 10703

Schaumburg, Illinois, 60194, United States

Location

Site Reference ID/Investigator# 6950

Skokie, Illinois, 60077, United States

Location

Site Reference ID/Investigator# 7892

West Dundee, Illinois, 60118, United States

Location

Site Reference ID/Investigator# 6933

Indianapolis, Indiana, 46256, United States

Location

Site Reference ID/Investigator# 10422

Indianapolis, Indiana, 46260, United States

Location

Site Reference ID/Investigator# 16581

Plainfield, Indiana, 46168, United States

Location

Site Reference ID/Investigator# 7992

Overland Park, Kansas, 66202, United States

Location

Site Reference ID/Investigator# 17193

Henderson, Kentucky, 42420, United States

Location

Site Reference ID/Investigator# 8528

Louisville, Kentucky, 40202, United States

Location

Site Reference ID/Investigator# 9962

Owensboro, Kentucky, 42303, United States

Location

Site Reference ID/Investigator# 8529

Andover, Massachusetts, 01810, United States

Location

Site Reference ID/Investigator# 8149

Boston, Massachusetts, 02111, United States

Location

Site Reference ID/Investigator# 9823

Detroit, Michigan, 48202, United States

Location

Site Reference ID/Investigator# 7883

Fort Gratiot, Michigan, 48059, United States

Location

Site Reference ID/Investigator# 7238

Grand Blanc, Michigan, 48439, United States

Location

Site Reference ID/Investigator# 7656

Fridley, Minnesota, 55432, United States

Location

Site Reference ID/Investigator# 6930

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 6949

St Louis, Missouri, 63117, United States

Location

Site Reference ID/Investigator# 7240

Omaha, Nebraska, 68131, United States

Location

Site Reference ID/Investigator# 9567

Omaha, Nebraska, 68144, United States

Location

Site Reference ID/Investigator# 7757

Berlin, New Jersey, 08009, United States

Location

Site Reference ID/Investigator# 7330

East Windsor, New Jersey, 08520, United States

Location

Site Reference ID/Investigator# 7882

New Brunswick, New Jersey, 08903, United States

Location

Site Reference ID/Investigator# 7455

Albuquerque, New Mexico, 87106, United States

Location

Site Reference ID/Investigator# 8078

Buffalo, New York, 14221, United States

Location

Site Reference ID/Investigator# 8392

New York, New York, 10016, United States

Location

Site Reference ID/Investigator# 8006

New York, New York, 10025, United States

Location

Site Reference ID/Investigator# 7230

New York, New York, 10029-6501, United States

Location

Site Reference ID/Investigator# 10201

New York, New York, 10032, United States

Location

Site Reference ID/Investigator# 8037

Rochester, New York, 14623, United States

Location

Site Reference ID/Investigator# 7333

Stoney Brook, New York, 11790, United States

Location

Site Reference ID/Investigator# 7434

Hickory, North Carolina, 28602, United States

Location

Site Reference ID/Investigator# 8117

Wilmington, North Carolina, 28401, United States

Location

Site Reference ID/Investigator# 9681

Winston-Salem, North Carolina, 27157, United States

Location

Site Reference ID/Investigator# 6945

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator# 23345

Cincinnati, Ohio, 45220, United States

Location

Site Reference ID/Investigator# 7044

Cleveland, Ohio, 44106, United States

Location

Site Reference ID/Investigator# 7899

Columbus, Ohio, 43212, United States

Location

Site Reference ID/Investigator# 8389

Dayton, Ohio, 45408, United States

Location

Site Reference ID/Investigator# 11181

Oklahoma City, Oklahoma, 73104, United States

Location

Site Reference ID/Investigator# 6936

Lake Oswego, Oregon, 97035, United States

Location

Site Reference ID/Investigator# 7703

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 6948

Portland, Oregon, 97223, United States

Location

Site Reference ID/Investigator# 11424

Portland, Oregon, 97239, United States

Location

Site Reference ID/Investigator# 8494

Hershey, Pennsylvania, 17033, United States

Location

Site Reference ID/Investigator# 7930

Philadelphia, Pennsylvania, 19103, United States

Location

Site Reference ID/Investigator# 6934

Johnston, Rhode Island, 02919, United States

Location

Site Reference ID/Investigator# 6935

Providence, Rhode Island, 02903, United States

Location

Site Reference ID/Investigator# 7785

Greer, South Carolina, 29650, United States

Location

Site Reference ID/Investigator# 7497

Goodlettsville, Tennessee, 37072, United States

Location

Site Reference ID/Investigator# 7388

Knoxville, Tennessee, 37934, United States

Location

Site Reference ID/Investigator# 6931

Nashville, Tennessee, 37215, United States

Location

Site Reference ID/Investigator# 7684

Arlington, Texas, 76011, United States

Location

Site Reference ID/Investigator# 10842

Austin, Texas, 78759, United States

Location

Site Reference ID/Investigator# 7498

Dallas, Texas, 75230, United States

Location

Site Reference ID/Investigator# 6947

Dallas, Texas, 75246-1613, United States

Location

Site Reference ID/Investigator# 6944

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 7758

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 8108

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 6937

Tyler, Texas, 75703, United States

Location

Site Reference ID/Investigator# 7655

Webster, Texas, 77598, United States

Location

Site Reference ID/Investigator# 10207

Salt Lake City, Utah, 84132, United States

Location

Site Reference ID/Investigator# 6946

Norfolk, Virginia, 23507, United States

Location

Site Reference ID/Investigator# 6932

Seattle, Washington, 98101, United States

Location

Site Reference ID/Investigator# 10306

Spokane, Washington, 99204, United States

Location

Site Reference ID/Investigator# 7884

Milwaukee, Wisconsin, 53209, United States

Location

Site Reference ID/Investigator# 16845

Graz, 8036, Austria

Location

Site Reference ID/Investigator# 18183

Vienna, 1090, Austria

Location

Site Reference ID/Investigator# 15761

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator# 7991

Barrie, L4M 6L2, Canada

Location

Site Reference ID/Investigator# 8047

Calgary, T3G 0B4, Canada

Location

Site Reference ID/Investigator# 7996

Edmonton, T5K 1X3, Canada

Location

Site Reference ID/Investigator# 6996

Halifax, B3H 0A2, Canada

Location

Site Reference ID/Investigator# 7236

Hamilton, L8N 1V6, Canada

Location

Site Reference ID/Investigator# 6995

Laval, H7S 2C6, Canada

Location

Site Reference ID/Investigator# 6998

London, N5X 2P1, Canada

Location

Site Reference ID/Investigator# 7043

London, N6A 3H7, Canada

Location

Site Reference ID/Investigator# 7329

Markham, L3P 1A8, Canada

Location

Site Reference ID/Investigator# 6999

Montreal, H2K 4L5, Canada

Location

Site Reference ID/Investigator# 7652

Montreal, H3H 1V4, Canada

Location

Site Reference ID/Investigator# 7006

North Bay, P1B 3Z7, Canada

Location

Site Reference ID/Investigator# 8102

Ottawa, K2G 6E2, Canada

Location

Site Reference ID/Investigator# 6993

Québec, G1V 4X7, Canada

Location

Site Reference ID/Investigator# 8112

St. John's, A1A 5E8, Canada

Location

Site Reference ID/Investigator# 7931

Surrey, V3R 6A7, Canada

Location

Site Reference ID/Investigator# 8118

Vancouver, V5Z 3Y1, Canada

Location

Site Reference ID/Investigator# 6997

Vancouver, V5Z 4E8, Canada

Location

Site Reference ID/Investigator# 6994

Waterloo, N2J 1C4, Canada

Location

Site Reference ID/Investigator# 8111

Westmount, H3Z 2S6, Canada

Location

Site Reference ID/Investigator# 7005

Windsor, N8W 1E6, Canada

Location

Site Reference ID/Investigator# 7979

Windsor, N8W 5L7, Canada

Location

Site Reference ID/Investigator# 8348

Winnipeg, R3C 1R4, Canada

Location

Site Reference ID/Investigator# 17781

Aarhus, 8000, Denmark

Location

Site Reference ID/Investigator# 18041

Copenhagen NV, 2400, Denmark

Location

Site Reference ID/Investigator# 18661

Helsinki, 00029 HUS, Finland

Location

Site Reference ID/Investigator# 18701

Kuopio, 70210, Finland

Location

Site Reference ID/Investigator# 14962

Lahti, 15850, Finland

Location

Site Reference ID/Investigator# 19241

Turku, 20521, Finland

Location

Site Reference ID/Investigator# 18502

Nice, 06200, France

Location

Site Reference ID/Investigator# 16781

Paris, 75475, France

Location

Site Reference ID/Investigator# 18506

Toulouse, 31059, France

Location

Site Reference ID/Investigator# 16281

Berlin, 10117, Germany

Location

Site Reference ID/Investigator# 15664

Frankfurt am Main, 60590, Germany

Location

Site Reference ID/Investigator# 15663

Hamburg, D-20354, Germany

Location

Site Reference ID/Investigator# 16381

Kiel, 24105, Germany

Location

Site Reference ID/Investigator# 16143

Munich, D-80337, Germany

Location

Site Reference ID/Investigator# 16161

Münster, 48149, Germany

Location

Site Reference ID/Investigator# 17676

Tübingen, 72076, Germany

Location

Site Reference ID/Investigator# 16282

Athens, 161 21, Greece

Location

Site Reference ID/Investigator# 15921

Athens, 16121, Greece

Location

Site Reference ID/Investigator# 15922

Thessaloniki, 54643, Greece

Location

Site Reference ID/Investigator# 15401

Modena, 41100, Italy

Location

Site Reference ID/Investigator# 14881

Rome, 00133, Italy

Location

Site Reference ID/Investigator# 19322

Barcelona, 08916, Spain

Location

Site Reference ID/Investigator# 15341

Madrid, 28006, Spain

Location

Site Reference ID/Investigator# 16142

Stockholm, 171 76, Sweden

Location

Site Reference ID/Investigator# 17721

Geneva, 1211, Switzerland

Location

Site Reference ID/Investigator# 16749

Zurich, 8091, Switzerland

Location

Site Reference ID/Investigator# 19045

Aberdeen, AB25 2ZR, United Kingdom

Location

Site Reference ID/Investigator# 15422

Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Interventions

briakinumab

Study Officials

• Martin Kaul, MD

  AbbVie

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

ES (2); DE (7); SE (1); CA (23); CH (2); BE (1); FI (4); GB (2); FR (3); IT (2); US (98); DK (2); GR (3); AU (2)