Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: adalimumab

Registration Number: NCT00195676

Lead Sponsor: Abbott

Brief Summary: The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.

Detailed Description: Study M03-658 was a continuation study for participants with moderate to severe psoriasis who had participated in a prior psoriasis adalimumab study. Study M03-658 consisted of three sequential treatment periods. The first period was Period O, in which participants received open-label treatment with adalimumab (40 mg every other week or 40 mg every week) for a minimum of 104 weeks and a maximum of 252 weeks. Period O was the only period of the study until May 2008, when the subsequent periods were added via amendment to the protocol. At that time, participants who had achieved satisfactory therapeutic response (a Physician's Global Assessment \[PGA\] of 0, 1, or 2 \[clear, minimal, or mild\]) were given the opportunity to discontinue from the study or to continue and participate in the subsequent two periods. The second period was Period W, a maximum of 52 weeks, in which participants with a PGA of 2 (mild) or less were withdrawn from adalimumab treatment (i.e., participants received no treatment) until relapse of their psoriasis occurred (defined as a PGA of 3 \[moderate\] or worse). The third period was Period R, a 16-week period in which participants were retreated with open-label adalimumab (80 mg initial dose followed by 40 mg every other week). Period O was designed to evaluate the first objective regarding long-term efficacy and safety of adalimumab treatment, and Period R was designed to evaluate the effectiveness of adalimumab retreatment following relapse. Specific subsets of the study population that were identified as the populations of interest were the modified intent-to-treat populations for Period W and Period R, and these are described further in the outcome measures.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1469

Inclusion Criteria

Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
Subjects who met the requirements from previous adalimumab psoriasis study participation.

Exclusion Criteria

Subject considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Female subject who was pregnant or breast-feeding or considering becoming pregnant.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adalimumab	adalimumab	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R	Week 16 of Period R	The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (104): Site Reference ID/Investigator# 1268
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Tyler, Texas, United States
Site Reference ID/Investigator# 2434
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Columbus, Ohio, United States
Site Reference ID/Investigator# 1683
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Boston, Massachusetts, United States
Site Reference ID/Investigator# 1677
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Torrance, California, United States
Site Reference ID/Investigator# 2182
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Madrid, Spain
Site Reference ID/Investigator# 1277
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Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 1266
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Raleigh, North Carolina, United States
Site Reference ID/Investigator# 1285
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Oceanside, California, United States
Site Reference ID/Investigator# 1679
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Santa Monica, California, United States
Site Reference ID/Investigator# 1269
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Longmont, Colorado, United States
Site Reference ID/Investigator# 96
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Jacksonville, Florida, United States
Site Reference ID/Investigator# 1681
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Springfield, Illinois, United States
Site Reference ID/Investigator# 1655
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New York, New York, United States
Site Reference ID/Investigator# 1798
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Bakersfield, California, United States
Site Reference ID/Investigator# 2431
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Pinellas Park, Florida, United States
Site Reference ID/Investigator# 1259
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Buckner 13075 PI, Alabama, United States
Site Reference ID/Investigator# 88
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Rochester, New York, United States
Site Reference ID/Investigator# 95
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New York, New York, United States
Site Reference ID/Investigator# 89
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St. Louis, Missouri, United States
Site Reference ID/Investigator# 92
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Fridley, Minnesota, United States
Site Reference ID/Investigator# 122
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Fresno, California, United States
Site Reference ID/Investigator# 1669
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Irvine, California, United States
Site Reference ID/Investigator# 1797
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New York, New York, United States
Site Reference ID/Investigator# 83
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Worcester, Massachusetts, United States
Site Reference ID/Investigator# 1657
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St. Louis, Missouri, United States
Site Reference ID/Investigator# 99
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Johnston, Rhode Island, United States
Site Reference ID/Investigator# 2190
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Paris, Cedex 10, France
Site Reference ID/Investigator# 2185
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Seville, Spain
Site Reference ID/Investigator# 87
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Dallas, Texas, United States
Site Reference ID/Investigator# 123
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Norfolk, Virginia, United States
Site Reference ID/Investigator# 1639
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North Bay, Ontario, Canada
Site Reference ID/Investigator# 103
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Windsor, Ontario, Canada
Site Reference ID/Investigator# 2553
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Creteil, France
Site Reference ID/Investigator# 2191
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Nice, France
Site Reference ID/Investigator# 120
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St. John's, Newfoundland and Labrador, Canada
Site Reference ID/Investigator# 2198
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Frankfurt, Germany
Site Reference ID/Investigator# 2183
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Valencia, Spain
Site Reference ID/Investigator# 2177
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Plock, Poland
Site Reference ID/Investigator# 1640
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Hamilton, Ontario, Canada
Site Reference ID/Investigator# 2189
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Saint Etienne, France
Site Reference ID/Investigator# 1802
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Quebec, Canada
Site Reference ID/Investigator# 2188
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Muenster, Germany
Site Reference ID/Investigator# 2187
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Tuebingen, Germany
Site Reference ID/Investigator# 86
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San Diego, California, United States
Site Reference ID/Investigator# 1267
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Indianapolis, Indiana, United States
Site Reference ID/Investigator# 1671
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Indianapolis, Indiana, United States
Site Reference ID/Investigator# 1265
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Cincinnati, Ohio, United States
Site Reference ID/Investigator# 1279
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Houston, Texas, United States
Site Reference ID/Investigator# 1653
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Seattle, Washington, United States
Site Reference ID/Investigator# 1262
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Minneapolis, Minnesota, United States
Site Reference ID/Investigator# 1665
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San Antonio, Texas, United States
Site Reference ID/Investigator# 2079
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Salt Lake City, Utah, United States
Site Reference ID/Investigator# 2181
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Graz, Austria
Site Reference ID/Investigator# 102
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Montreal, Quebec, Canada
Site Reference ID/Investigator# 1637
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Montreal, Quebec, Canada
Site Reference ID/Investigator# 2194
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Cagaus, Puerto Rico
Site Reference ID/Investigator# 1263
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Birmingham, Alabama, United States
Site Reference ID/Investigator# 1668
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Andover, Massachusetts, United States
Site Reference ID/Investigator# 90
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Cleveland, Ohio, United States
Site Reference ID/Investigator# 93
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Ann Arbor, Michigan, United States
Site Reference ID/Investigator# 1667
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Portland, Oregon, United States
Site Reference ID/Investigator# 121
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Portland, Oregon, United States
Site Reference ID/Investigator# 98
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Alpharetta, Georgia, United States
Site Reference ID/Investigator# 2433
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Tucson, Arizona, United States
Site Reference ID/Investigator# 100
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Little Rock, Arkansas, United States
Site Reference ID/Investigator# 2432
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West Palm Beach, Florida, United States
Site Reference ID/Investigator# 1273
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South Miami, Florida, United States
Site Reference ID/Investigator# 1670
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Snellville, Georgia, United States
Site Reference ID/Investigator# 1674
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Newnan, Georgia, United States
Site Reference ID/Investigator# 1264
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Chicago, Illinois, United States
Site Reference ID/Investigator# 1801
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Maywood, Illinois, United States
Site Reference ID/Investigator# 1672
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New York, New York, United States
Site Reference ID/Investigator# 1256
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Williamsville, New York, United States
Site Reference ID/Investigator# 1260
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Lake Oswego, Oregon, United States
Site Reference ID/Investigator# 1323
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Hershey, Pennsylvania, United States
Site Reference ID/Investigator# 94
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Halifax, Nova Scotia, Canada
Site Reference ID/Investigator# 104
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Vancouver, British Columbia, Canada
Site Reference ID/Investigator# 1631
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Waterloo, Ontario, Canada
Site Reference ID/Investigator# 1633
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Toronto, Ontario, Canada
Site Reference ID/Investigator# 2543
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Kiel, Germany
Site Reference ID/Investigator# 2193
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Geneva 14, Switzerland
Site Reference ID/Investigator# 1800
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Goodlettsville, Tennessee, United States
Site Reference ID/Investigator# 1281
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Shreveport, Louisiana, United States
Site Reference ID/Investigator# 2119
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New Brunswick, New Jersey, United States
Site Reference ID/Investigator# 1282
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Nashville, Tennessee, United States
Site Reference ID/Investigator# 1673
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Omaha, Nebraska, United States
Site Reference ID/Investigator# 2179
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Edegem, Belgium
Site Reference ID/Investigator# 97
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Greer, South Carolina, United States
Site Reference ID/Investigator# 2554
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Brussels, Belgium
Site Reference ID/Investigator# 2180
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Innsbruck, Austria
Site Reference ID/Investigator# 2176
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Vienna, Austria
Site Reference ID/Investigator# 101
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Montreal, Quebec, Canada
Site Reference ID/Investigator# 2178
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Gdansk, Poland
Site Reference ID/Investigator# 5507
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Carolina, Puerto Rico
Site Reference ID/Investigator# 1258
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Louisville, Kentucky, United States
Site Reference ID/Investigator# 1275
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New Haven, Connecticut, United States
Site Reference ID/Investigator#1641
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Edmonton, Alberta, Canada
Site Reference ID/Investigator# 1635
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St. John's, Newfoundland and Labrador, Canada
Site Reference ID/Investigator# 1676
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Providence, Rhode Island, United States
Site Reference ID/Investigator# 1629
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Calgary, Alberta, Canada
Site Reference ID/Investigator# 1636
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London, Ontario, Canada
Site Reference ID/Investigator# 1647
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Westmount, Quebec, Canada
Site Reference ID/Investigator# 2427
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Scottsdale, Arizona, United States
Site Reference ID/Investigator# 5199
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Mount Pleasant, South Carolina, United States