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Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Placebo
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:

  • Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA >/=3 and candidates for systemic therapy;
  • Patients in good general health
  • Able to self-administer injections
  • Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis

Exclusion Criteria:

  • Previous treatment with HUMIRA®
  • Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)
  • Other active skin diseases or skin infections
  • Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis
  • Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);
  • History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB);
  • History of moderate to severe congestive heart failure,
  • Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk;
  • History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease;
  • History of clinically significant drug or alcohol abuse in the last 12 months;
  • Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline;
  • Known hypersensitivity to the excipients of HUMIRA® as stated in the label;
  • Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
  • Prior exposure to Tysabri® (natalizumab)

Sites / Locations

  • Site Reference ID/Investigator# 10168
  • Site Reference ID/Investigator# 10005
  • Site Reference ID/Investigator# 10003
  • Site Reference ID/Investigator# 10171
  • Site Reference ID/Investigator# 10164
  • Site Reference ID/Investigator# 10173
  • Site Reference ID/Investigator# 11302
  • Site Reference ID/Investigator# 10166
  • Site Reference ID/Investigator# 10180
  • Site Reference ID/Investigator# 10169
  • Site Reference ID/Investigator# 10170
  • Site Reference ID/Investigator# 10179
  • Site Reference ID/Investigator# 10004
  • Site Reference ID/Investigator# 10177
  • Site Reference ID/Investigator# 10175
  • Site Reference ID/Investigator# 10165
  • Site Reference ID/Investigator# 10176

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo/Adalimumab

Adalimumab

Arm Description

Loading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15. In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.

80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27.

Outcomes

Primary Outcome Measures

Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

Secondary Outcome Measures

Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.
Mean Change From Baseline in ESIF for Palms
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.
Mean Change From Baseline in ESIF for Soles
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.
Number of Subjects With Moderate Improvement in ESIF From Baseline
Number of subjects that achieved > 50% reduction from Baseline in ESIF.
Number of Subjects With Marked Improvement in ESIF From Baseline
Number of subjects that achieved > 75% reduction from Baseline in ESIF
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Number of Subjects With PGA of Clear or Almost Clear
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Number of Subjects With PGA of Clear
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50
Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Number of Subjects With PASI 75
Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Number of Subjects With PASI 90
Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Number of Subjects With PASI 100
Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Number of Subjects Achieving a DLQI of 0
Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain
On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)
WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).
Number of Subjects With Difficulties According to PHQ-9
Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).

Full Information

First Posted
August 13, 2008
Last Updated
October 11, 2010
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00735787
Brief Title
Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Official Title
Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.

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 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo/Adalimumab
Arm Type
Placebo Comparator
Arm Description
Loading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15. In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira, ABT-D2E7
Intervention Description
Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.
Primary Outcome Measure Information:
Title
Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
Description
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)
Description
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Title
Mean Change From Baseline in ESIF for Palms
Description
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.
Time Frame
Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28
Title
Mean Change From Baseline in ESIF for Soles
Description
Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Title
Number of Subjects With Moderate Improvement in ESIF From Baseline
Description
Number of subjects that achieved > 50% reduction from Baseline in ESIF.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Title
Number of Subjects With Marked Improvement in ESIF From Baseline
Description
Number of subjects that achieved > 75% reduction from Baseline in ESIF
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
Title
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Description
For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).
Time Frame
Baseline and Weeks 8, 16, and 28
Title
Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild
Description
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
Title
Number of Subjects With PGA of Clear or Almost Clear
Description
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28
Title
Number of Subjects With PGA of Clear
Description
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
Title
Number of Subjects With Psoriasis Area and Severity Index (PASI) 50
Description
Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time Frame
Baseline and Weeks 16 and 28
Title
Number of Subjects With PASI 75
Description
Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time Frame
Baseline and Weeks 16 and 28
Title
Number of Subjects With PASI 90
Description
Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time Frame
Baseline and Weeks 16 and 28
Title
Number of Subjects With PASI 100
Description
Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time Frame
Baseline and Weeks 16 and 28
Title
Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
Description
The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Time Frame
Baseline and Weeks 2, 8, 16, and 28
Title
Number of Subjects Achieving a DLQI of 0
Description
Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Time Frame
Baseline and Weeks 2, 8, 16, and 28
Title
Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain
Description
On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).
Time Frame
Baseline and Weeks 16 and 28
Title
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)
Description
WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).
Time Frame
Baseline and Weeks 8, 16, and 28
Title
Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).
Time Frame
Baseline and Weeks 2, 8, 16, and 28
Title
Number of Subjects With Difficulties According to PHQ-9
Description
Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).
Time Frame
Baseline and Weeks 2, 8, 16, and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA >/=3 and candidates for systemic therapy; Patients in good general health Able to self-administer injections Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis Exclusion Criteria: Previous treatment with HUMIRA® Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA) Other active skin diseases or skin infections Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix); History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB); History of moderate to severe congestive heart failure, Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk; History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease; History of clinically significant drug or alcohol abuse in the last 12 months; Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline; Known hypersensitivity to the excipients of HUMIRA® as stated in the label; Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study. Prior exposure to Tysabri® (natalizumab)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Okun, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 10168
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Site Reference ID/Investigator# 10005
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Site Reference ID/Investigator# 10003
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Site Reference ID/Investigator# 10171
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Site Reference ID/Investigator# 10164
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Facility Name
Site Reference ID/Investigator# 10173
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246-1613
Country
United States
Facility Name
Site Reference ID/Investigator# 11302
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference ID/Investigator# 10166
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Site Reference ID/Investigator# 10180
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K 1X3
Country
Canada
Facility Name
Site Reference ID/Investigator# 10169
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Site Reference ID/Investigator# 10170
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1Z4
Country
Canada
Facility Name
Site Reference ID/Investigator# 10179
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
Site Reference ID/Investigator# 10004
City
London
State/Province
Ontario
ZIP/Postal Code
N5X 2P1
Country
Canada
Facility Name
Site Reference ID/Investigator# 10177
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
Site Reference ID/Investigator# 10175
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Site Reference ID/Investigator# 10165
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2K 4L5
Country
Canada
Facility Name
Site Reference ID/Investigator# 10176
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21173304
Citation
Leonardi C, Langley RG, Papp K, Tyring SK, Wasel N, Vender R, Unnebrink K, Gupta SR, Valdecantos WC, Bagel J. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011 Apr;147(4):429-36. doi: 10.1001/archdermatol.2010.384. Epub 2010 Dec 20.
Results Reference
derived
Links:
URL
http://www.humira.com
Description
prescribing information

Learn more about this trial

Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

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