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

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 1263
  • Site Reference ID/Investigator# 1259
  • Site Reference ID/Investigator# 2427
  • Site Reference ID/Investigator# 2433
  • Site Reference ID/Investigator# 100
  • Site Reference ID/Investigator# 1798
  • Site Reference ID/Investigator# 122
  • Site Reference ID/Investigator# 1669
  • Site Reference ID/Investigator# 1285
  • Site Reference ID/Investigator# 86
  • Site Reference ID/Investigator# 1679
  • Site Reference ID/Investigator# 1677
  • Site Reference ID/Investigator# 1269
  • Site Reference ID/Investigator# 1275
  • Site Reference ID/Investigator# 96
  • Site Reference ID/Investigator# 2431
  • Site Reference ID/Investigator# 1273
  • Site Reference ID/Investigator# 2432
  • Site Reference ID/Investigator# 98
  • Site Reference ID/Investigator# 1674
  • Site Reference ID/Investigator# 1670
  • Site Reference ID/Investigator# 1264
  • Site Reference ID/Investigator# 1801
  • Site Reference ID/Investigator# 1681
  • Site Reference ID/Investigator# 1267
  • Site Reference ID/Investigator# 1671
  • Site Reference ID/Investigator# 1258
  • Site Reference ID/Investigator# 1281
  • Site Reference ID/Investigator# 1668
  • Site Reference ID/Investigator# 1683
  • Site Reference ID/Investigator# 83
  • Site Reference ID/Investigator# 93
  • Site Reference ID/Investigator# 92
  • Site Reference ID/Investigator# 1262
  • Site Reference ID/Investigator# 1657
  • Site Reference ID/Investigator# 89
  • Site Reference ID/Investigator# 1673
  • Site Reference ID/Investigator# 2119
  • Site Reference ID/Investigator# 1672
  • Site Reference ID/Investigator# 1797
  • Site Reference ID/Investigator# 95
  • Site Reference ID/Investigator# 1655
  • Site Reference ID/Investigator# 88
  • Site Reference ID/Investigator# 1256
  • Site Reference ID/Investigator# 1266
  • Site Reference ID/Investigator# 1265
  • Site Reference ID/Investigator# 90
  • Site Reference ID/Investigator# 2434
  • Site Reference ID/Investigator# 1260
  • Site Reference ID/Investigator# 1667
  • Site Reference ID/Investigator# 121
  • Site Reference ID/Investigator# 1323
  • Site Reference ID/Investigator# 1277
  • Site Reference ID/Investigator# 99
  • Site Reference ID/Investigator# 1676
  • Site Reference ID/Investigator# 97
  • Site Reference ID/Investigator# 5199
  • Site Reference ID/Investigator# 1800
  • Site Reference ID/Investigator# 1282
  • Site Reference ID/Investigator# 87
  • Site Reference ID/Investigator# 1279
  • Site Reference ID/Investigator# 1665
  • Site Reference ID/Investigator# 1268
  • Site Reference ID/Investigator# 2079
  • Site Reference ID/Investigator# 123
  • Site Reference ID/Investigator# 1653
  • Site Reference ID/Investigator# 2181
  • Site Reference ID/Investigator# 2180
  • Site Reference ID/Investigator# 2176
  • Site Reference ID/Investigator# 2554
  • Site Reference ID/Investigator# 2179
  • Site Reference ID/Investigator# 1629
  • Site Reference ID/Investigator#1641
  • Site Reference ID/Investigator# 104
  • Site Reference ID/Investigator# 1635
  • Site Reference ID/Investigator# 120
  • Site Reference ID/Investigator# 94
  • Site Reference ID/Investigator# 1640
  • Site Reference ID/Investigator# 1636
  • Site Reference ID/Investigator# 1639
  • Site Reference ID/Investigator# 1633
  • Site Reference ID/Investigator# 1631
  • Site Reference ID/Investigator# 103
  • Site Reference ID/Investigator# 102
  • Site Reference ID/Investigator# 1637
  • Site Reference ID/Investigator# 101
  • Site Reference ID/Investigator# 1647
  • Site Reference ID/Investigator# 1802
  • Site Reference ID/Investigator# 2553
  • Site Reference ID/Investigator# 2191
  • Site Reference ID/Investigator# 2190
  • Site Reference ID/Investigator# 2189
  • Site Reference ID/Investigator# 2198
  • Site Reference ID/Investigator# 2543
  • Site Reference ID/Investigator# 2188
  • Site Reference ID/Investigator# 2187
  • Site Reference ID/Investigator# 2178
  • Site Reference ID/Investigator# 2177
  • Site Reference ID/Investigator# 2194
  • Site Reference ID/Investigator# 5507
  • Site Reference ID/Investigator# 2182
  • Site Reference ID/Investigator# 2185
  • Site Reference ID/Investigator# 2183
  • Site Reference ID/Investigator# 2193

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Adalimumab

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at 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

Full Information

First Posted
September 13, 2005
Last Updated
April 11, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00195676
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1469 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
40 mg every other week or 40 mg every week by subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R
Description
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.
Time Frame
Week 16 of Period R
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60
Description
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.
Time Frame
Week 60
Title
Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120
Description
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.
Time Frame
Week 120
Title
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60
Description
Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.
Time Frame
Week 60
Title
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120
Description
Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.
Time Frame
Week 120
Title
Time to Relapse in Period W
Description
Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe).
Time Frame
Period W
Title
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
Description
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.
Time Frame
Week 16 of Period R
Title
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
Description
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.
Time Frame
Week 16 of Period R

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Okun, MD, PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 1263
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Site Reference ID/Investigator# 1259
City
Buckner 13075 PI
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Site Reference ID/Investigator# 2427
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Site Reference ID/Investigator# 2433
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Site Reference ID/Investigator# 100
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Site Reference ID/Investigator# 1798
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Site Reference ID/Investigator# 122
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Site Reference ID/Investigator# 1669
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Site Reference ID/Investigator# 1285
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Site Reference ID/Investigator# 86
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site Reference ID/Investigator# 1679
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Site Reference ID/Investigator# 1677
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Site Reference ID/Investigator# 1269
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Site Reference ID/Investigator# 1275
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Site Reference ID/Investigator# 96
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Site Reference ID/Investigator# 2431
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Site Reference ID/Investigator# 1273
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Site Reference ID/Investigator# 2432
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Site Reference ID/Investigator# 98
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Site Reference ID/Investigator# 1674
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Site Reference ID/Investigator# 1670
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Site Reference ID/Investigator# 1264
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Site Reference ID/Investigator# 1801
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Site Reference ID/Investigator# 1681
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Site Reference ID/Investigator# 1267
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Site Reference ID/Investigator# 1671
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Site Reference ID/Investigator# 1258
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Site Reference ID/Investigator# 1281
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Site Reference ID/Investigator# 1668
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Site Reference ID/Investigator# 1683
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Site Reference ID/Investigator# 83
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Site Reference ID/Investigator# 93
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Site Reference ID/Investigator# 92
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Site Reference ID/Investigator# 1262
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Site Reference ID/Investigator# 1657
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site Reference ID/Investigator# 89
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Site Reference ID/Investigator# 1673
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Site Reference ID/Investigator# 2119
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Site Reference ID/Investigator# 1672
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Site Reference ID/Investigator# 1797
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Site Reference ID/Investigator# 95
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Site Reference ID/Investigator# 1655
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Site Reference ID/Investigator# 88
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Site Reference ID/Investigator# 1256
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Site Reference ID/Investigator# 1266
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Site Reference ID/Investigator# 1265
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Reference ID/Investigator# 90
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Site Reference ID/Investigator# 2434
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Site Reference ID/Investigator# 1260
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Site Reference ID/Investigator# 1667
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Site Reference ID/Investigator# 121
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Site Reference ID/Investigator# 1323
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Site Reference ID/Investigator# 1277
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Site Reference ID/Investigator# 99
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Site Reference ID/Investigator# 1676
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Site Reference ID/Investigator# 97
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Site Reference ID/Investigator# 5199
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site Reference ID/Investigator# 1800
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Site Reference ID/Investigator# 1282
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Site Reference ID/Investigator# 87
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-1613
Country
United States
Facility Name
Site Reference ID/Investigator# 1279
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference ID/Investigator# 1665
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 1268
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States
Facility Name
Site Reference ID/Investigator# 2079
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Site Reference ID/Investigator# 123
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Site Reference ID/Investigator# 1653
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Site Reference ID/Investigator# 2181
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Site Reference ID/Investigator# 2180
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Site Reference ID/Investigator# 2176
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Site Reference ID/Investigator# 2554
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Site Reference ID/Investigator# 2179
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Site Reference ID/Investigator# 1629
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3B3
Country
Canada
Facility Name
Site Reference ID/Investigator#1641
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Site Reference ID/Investigator# 104
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Site Reference ID/Investigator# 1635
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 4S8
Country
Canada
Facility Name
Site Reference ID/Investigator# 120
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 2H5
Country
Canada
Facility Name
Site Reference ID/Investigator# 94
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z4
Country
Canada
Facility Name
Site Reference ID/Investigator# 1640
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
Site Reference ID/Investigator# 1636
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
Facility Name
Site Reference ID/Investigator# 1639
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Site Reference ID/Investigator# 1633
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 2T3
Country
Canada
Facility Name
Site Reference ID/Investigator# 1631
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Site Reference ID/Investigator# 103
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Site Reference ID/Investigator# 102
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Site Reference ID/Investigator# 1637
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Site Reference ID/Investigator# 101
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Site Reference ID/Investigator# 1647
City
Westmount
State/Province
Quebec
ZIP/Postal Code
H3Z 2S6
Country
Canada
Facility Name
Site Reference ID/Investigator# 1802
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada
Facility Name
Site Reference ID/Investigator# 2553
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Site Reference ID/Investigator# 2191
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Site Reference ID/Investigator# 2190
City
Paris, Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Site Reference ID/Investigator# 2189
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Site Reference ID/Investigator# 2198
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Site Reference ID/Investigator# 2543
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Site Reference ID/Investigator# 2188
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Site Reference ID/Investigator# 2187
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Site Reference ID/Investigator# 2178
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Site Reference ID/Investigator# 2177
City
Plock
ZIP/Postal Code
09-402
Country
Poland
Facility Name
Site Reference ID/Investigator# 2194
City
Cagaus
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 5507
City
Carolina
ZIP/Postal Code
00985
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 2182
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Site Reference ID/Investigator# 2185
City
Seville
ZIP/Postal Code
41009
Country
Spain
Facility Name
Site Reference ID/Investigator# 2183
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Site Reference ID/Investigator# 2193
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21752491
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.
Results Reference
derived
PubMed Identifier
21083543
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.
Results Reference
derived

Learn more about this trial

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

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