Clinical trial NCT00195676: Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official title: A Multicenter Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Who Completed a Preceding Psoriasis Clinical Study With Adalimumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 1469
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 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the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.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 The second period was Period W, a maximum of 52 weeks, in which participants with a PGA of 2 (mild) or less were withdrawn from adalimumab treatment (i.e., participants received no treatment) until relapse of their psoriasis occurred (defined as a PGA of 3 \[moderate\] or worse).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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R
timeFrame: Week 16 of Period R
Secondary outcomes:
Other outcomes:
measure: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60
timeFrame: Week 60
measure: Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120
timeFrame: Week 120
measure: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60
timeFrame: Week 60
measure: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120
timeFrame: Week 120
measure: Time to Relapse in Period W
timeFrame: Period W
measure: Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R
timeFrame: Week 16 of Period R
measure: Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R
timeFrame: Week 16 of Period R
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 1263
state: Alabama
city: Buckner 13075 PI
country: United States
facility: Site Reference ID/Investigator# 1259
state: Alabama
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 2427
state: Arizona
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 2433
state: Arizona
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 100
state: Arkansas
city: Bakersfield
country: United States
facility: Site Reference ID/Investigator# 1798
state: California
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 122
state: California
city: Irvine
country: United States
facility: Site Reference ID/Investigator# 1669
state: California
city: Oceanside
country: United States
facility: Site Reference ID/Investigator# 1285
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 86
state: California
city: Santa Monica
country: United States
facility: Site Reference ID/Investigator# 1679
state: California
city: Torrance
country: United States
facility: Site Reference ID/Investigator# 1677
state: California
city: Longmont
country: United States
facility: Site Reference ID/Investigator# 1269
state: Colorado
city: New Haven
country: United States
facility: Site Reference ID/Investigator# 1275
state: Connecticut
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 96
state: Florida
city: Pinellas Park
country: United States
facility: Site Reference ID/Investigator# 2431
state: Florida
city: South Miami
country: United States
facility: Site Reference ID/Investigator# 1273
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 2432
state: Florida
city: Alpharetta
country: United States
facility: Site Reference ID/Investigator# 98
state: Georgia
city: Newnan
country: United States
facility: Site Reference ID/Investigator# 1674
state: Georgia
city: Snellville
country: United States
facility: Site Reference ID/Investigator# 1670
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 1264
state: Illinois
city: Maywood
country: United States
facility: Site Reference ID/Investigator# 1801
state: Illinois
city: Springfield
country: United States
facility: Site Reference ID/Investigator# 1681
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 1267
state: Indiana
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 1671
state: Indiana
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 1258
state: Kentucky
city: Shreveport
country: United States
facility: Site Reference ID/Investigator# 1281
state: Louisiana
city: Andover
country: United States
facility: Site Reference ID/Investigator# 1668
state: Massachusetts
city: Boston
country: United States
facility: Site Reference ID/Investigator# 1683
state: Massachusetts
city: Worcester
country: United States
facility: Site Reference ID/Investigator# 83
state: Massachusetts
city: Ann Arbor
country: United States
facility: Site Reference ID/Investigator# 93
state: Michigan
city: Fridley
country: United States
facility: Site Reference ID/Investigator# 92
state: Minnesota
city: Minneapolis
country: United States
facility: Site Reference ID/Investigator# 1262
state: Minnesota
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 1657
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 89
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 1673
state: Nebraska
city: New Brunswick
country: United States
facility: Site Reference ID/Investigator# 2119
state: New Jersey
city: New York
country: United States
facility: Site Reference ID/Investigator# 1672
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 1797
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 95
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 1655
state: New York
city: Rochester
country: United States
facility: Site Reference ID/Investigator# 88
state: New York
city: Williamsville
country: United States
facility: Site Reference ID/Investigator# 1256
state: New York
city: Raleigh
country: United States
facility: Site Reference ID/Investigator# 1266
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 1265
state: Ohio
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 90
state: Ohio
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 2434
state: Ohio
city: Lake Oswego
country: United States
facility: Site Reference ID/Investigator# 1260
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 1667
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 121
state: Oregon
city: Hershey
country: United States
facility: Site Reference ID/Investigator# 1323
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 1277
state: Pennsylvania
city: Johnston
country: United States
facility: Site Reference ID/Investigator# 99
state: Rhode Island
city: Providence
country: United States
facility: Site Reference ID/Investigator# 1676
state: Rhode Island
city: Greer
country: United States
facility: Site Reference ID/Investigator# 97
state: South Carolina
city: Mount Pleasant
country: United States
facility: Site Reference ID/Investigator# 5199
state: South Carolina
city: Goodlettsville
country: United States
facility: Site Reference ID/Investigator# 1800
state: Tennessee
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 1282
state: Tennessee
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 87
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 1279
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 1665
state: Texas
city: Tyler
country: United States
facility: Site Reference ID/Investigator# 1268
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 2079
state: Utah
city: Norfolk
country: United States
facility: Site Reference ID/Investigator# 123
state: Virginia
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 1653
state: Washington
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 2181
city: Innsbruck
country: Austria
facility: Site Reference ID/Investigator# 2180
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 2176
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 2554
city: Edegem
country: Belgium
facility: Site Reference ID/Investigator# 2179
city: Calgary
country: Canada
facility: Site Reference ID/Investigator# 1629
state: Alberta
city: Edmonton
country: Canada
facility: Site Reference ID/Investigator#1641
state: Alberta
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 104
state: British Columbia
city: St. John's
country: Canada
facility: Site Reference ID/Investigator# 1635
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Site Reference ID/Investigator# 120
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Site Reference ID/Investigator# 94
state: Nova Scotia
city: Hamilton
country: Canada
facility: Site Reference ID/Investigator# 1640
state: Ontario
city: London
country: Canada
facility: Site Reference ID/Investigator# 1636
state: Ontario
city: North Bay
country: Canada
facility: Site Reference ID/Investigator# 1639
state: Ontario
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 1633
state: Ontario
city: Waterloo
country: Canada
facility: Site Reference ID/Investigator# 1631
state: Ontario
city: Windsor
country: Canada
facility: Site Reference ID/Investigator# 103
state: Ontario
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 102
state: Quebec
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 1637
state: Quebec
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 101
state: Quebec
city: Westmount
country: Canada
facility: Site Reference ID/Investigator# 1647
state: Quebec
city: Quebec
country: Canada
facility: Site Reference ID/Investigator# 1802
city: Creteil
country: France
facility: Site Reference ID/Investigator# 2553
city: Nice
country: France
facility: Site Reference ID/Investigator# 2191
city: Paris, Cedex 10
country: France
facility: Site Reference ID/Investigator# 2190
city: Saint Etienne
country: France
facility: Site Reference ID/Investigator# 2189
city: Frankfurt
country: Germany
facility: Site Reference ID/Investigator# 2198
city: Kiel
country: Germany
facility: Site Reference ID/Investigator# 2543
city: Muenster
country: Germany
facility: Site Reference ID/Investigator# 2188
city: Tuebingen
country: Germany
facility: Site Reference ID/Investigator# 2187
city: Gdansk
country: Poland
facility: Site Reference ID/Investigator# 2178
city: Plock
country: Poland
facility: Site Reference ID/Investigator# 2177
city: Cagaus
country: Puerto Rico
facility: Site Reference ID/Investigator# 2194
city: Carolina
country: Puerto Rico
facility: Site Reference ID/Investigator# 5507
city: Madrid
country: Spain
facility: Site Reference ID/Investigator# 2182
city: Seville
country: Spain
facility: Site Reference ID/Investigator# 2185
city: Valencia
country: Spain
facility: Site Reference ID/Investigator# 2183
city: Geneva 14
country: Switzerland
facility: Site Reference ID/Investigator# 2193
Study officials:
affiliation: Abbott
name: Martin Okun, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14.
citation: Papp K, Crowley J, Ortonne JP, Leu J, Okun M, Gupta SR, Gu Y, Langley RG. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011 Feb;164(2):434-41. doi: 10.1111/j.1365-2133.2010.10139.x.