Clinical trial NCT00735787: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
measure: Mean Change From Baseline in ESIF for Palms
timeFrame: Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28
measure: Mean Change From Baseline in ESIF for Soles
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
measure: Number of Subjects With Moderate Improvement in ESIF From Baseline
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
measure: Number of Subjects With Marked Improvement in ESIF From Baseline
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28
measure: Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
timeFrame: Baseline and Weeks 8, 16, and 28
measure: Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
measure: Number of Subjects With PGA of Clear or Almost Clear
timeFrame: Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28
measure: Number of Subjects With PGA of Clear
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28
measure: Number of Subjects With Psoriasis Area and Severity Index (PASI) 50
timeFrame: Baseline and Weeks 16 and 28
measure: Number of Subjects With PASI 75
timeFrame: Baseline and Weeks 16 and 28
measure: Number of Subjects With PASI 90
timeFrame: Baseline and Weeks 16 and 28
measure: Number of Subjects With PASI 100
timeFrame: Baseline and Weeks 16 and 28
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and Weeks 2, 8, 16, and 28
measure: Number of Subjects Achieving a DLQI of 0
timeFrame: Baseline and Weeks 2, 8, 16, and 28
measure: Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain
timeFrame: Baseline and Weeks 16 and 28
measure: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)
timeFrame: Baseline and Weeks 8, 16, and 28
measure: Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and Weeks 2, 8, 16, and 28
measure: Number of Subjects With Difficulties According to PHQ-9
timeFrame: Baseline and Weeks 2, 8, 16, and 28
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 10168
state: Arkansas
city: Bakersfield
country: United States
facility: Site Reference ID/Investigator# 10005
state: California
city: Macon
country: United States
facility: Site Reference ID/Investigator# 10003
state: Georgia
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 10171
state: Missouri
city: East Windsor
country: United States
facility: Site Reference ID/Investigator# 10164
state: New Jersey
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 10173
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 11302
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 10166
state: Texas
city: Edmonton
country: Canada
facility: Site Reference ID/Investigator# 10180
state: Alberta
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 10169
state: British Columbia
city: Halifax
country: Canada
facility: Site Reference ID/Investigator# 10170
state: Nova Scotia
city: Hamilton
country: Canada
facility: Site Reference ID/Investigator# 10179
state: Ontario
city: London
country: Canada
facility: Site Reference ID/Investigator# 10004
state: Ontario
city: North Bay
country: Canada
facility: Site Reference ID/Investigator# 10177
state: Ontario
city: Waterloo
country: Canada
facility: Site Reference ID/Investigator# 10175
state: Ontario
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 10165
state: Quebec
city: Quebec
country: Canada
facility: Site Reference ID/Investigator# 10176
Study officials:
affiliation: Abbott
name: Martin Okun, MD
role: STUDY_DIRECTOR
References:
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.