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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735787
• Other study ID #: M10-405
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2008
• Last updated: October 11, 2010
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Placebo
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.
• Adalimumab
Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 10180	Edmonton	Alberta
Canada	Site Reference ID/Investigator# 10170	Halifax	Nova Scotia
Canada	Site Reference ID/Investigator# 10179	Hamilton	Ontario
Canada	Site Reference ID/Investigator# 10004	London	Ontario
Canada	Site Reference ID/Investigator# 10165	Montreal	Quebec
Canada	Site Reference ID/Investigator# 10177	North Bay	Ontario
Canada	Site Reference ID/Investigator# 10176	Quebec
Canada	Site Reference ID/Investigator# 10169	Vancouver	British Columbia
Canada	Site Reference ID/Investigator# 10175	Waterloo	Ontario
United States	Site Reference ID/Investigator# 10005	Bakersfield	California
United States	Site Reference ID/Investigator# 10173	Dallas	Texas
United States	Site Reference ID/Investigator# 10164	East Windsor	New Jersey
United States	Site Reference ID/Investigator# 11302	Houston	Texas
United States	Site Reference ID/Investigator# 10168	Little Rock	Arkansas
United States	Site Reference ID/Investigator# 10003	Macon	Georgia
United States	Site Reference ID/Investigator# 10166	San Antonio	Texas
United States	Site Reference ID/Investigator# 10171	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 16	No
Secondary	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.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28	No
Secondary	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.	Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28	No
Secondary	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.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28	No
Secondary	Number of Subjects With Moderate Improvement in ESIF From Baseline	Number of subjects that achieved > 50% reduction from Baseline in ESIF.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28	No
Secondary	Number of Subjects With Marked Improvement in ESIF From Baseline	Number of subjects that achieved > 75% reduction from Baseline in ESIF	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28	No
Secondary	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).	Baseline and Weeks 8, 16, and 28	No
Secondary	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.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28	No
Secondary	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.	Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28	No
Secondary	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.	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28	No
Secondary	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).	Baseline and Weeks 16 and 28	No
Secondary	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).	Baseline and Weeks 16 and 28	No
Secondary	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).	Baseline and Weeks 16 and 28	No
Secondary	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).	Baseline and Weeks 16 and 28	No
Secondary	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.	Baseline and Weeks 2, 8, 16, and 28	No
Secondary	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.	Baseline and Weeks 2, 8, 16, and 28	No
Secondary	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).	Baseline and Weeks 16 and 28	No
Secondary	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]).	Baseline and Weeks 8, 16, and 28	No
Secondary	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).	Baseline and Weeks 2, 8, 16, and 28	No
Secondary	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).	Baseline and Weeks 2, 8, 16, and 28	No

External Links

•   prescribing information