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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Placebo; Biological: Adalimumab

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4X7
    • Site Reference ID/Investigator# 10176
  • Alberta
    • Edmonton, Alberta, Canada, T5K 1X3
      • Site Reference ID/Investigator# 10180
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Site Reference ID/Investigator# 10169
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1Z4
      • Site Reference ID/Investigator# 10170
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1V6
      • Site Reference ID/Investigator# 10179
    • London, Ontario, Canada, N5X 2P1
      • Site Reference ID/Investigator# 10004
    • North Bay, Ontario, Canada, P1B 3Z7
      • Site Reference ID/Investigator# 10177
    • Waterloo, Ontario, Canada, N2J 1C4
      • Site Reference ID/Investigator# 10175
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Site Reference ID/Investigator# 10165
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Site Reference ID/Investigator# 10168
  • California
    • Bakersfield, California, United States, 93309
      • Site Reference ID/Investigator# 10005
  • Georgia
    • Macon, Georgia, United States, 31217
      • Site Reference ID/Investigator# 10003
  • Missouri
    • St. Louis, Missouri, United States, 63117
      • Site Reference ID/Investigator# 10171
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Site Reference ID/Investigator# 10164
  • Texas
    • Dallas, Texas, United States, 75246-1613
      • Site Reference ID/Investigator# 10173
    • Houston, Texas, United States, 77030
      • Site Reference ID/Investigator# 11302
    • San Antonio, Texas, United States, 78258
      • Site Reference ID/Investigator# 10166

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo/Adalimumab; 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.	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.; Biological: Adalimumab; Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.; Other Names: ABT-D2E7; Humira
Active Comparator: Adalimumab; 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.	Biological: Adalimumab; Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.; Other Names: ABT-D2E7; Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Martin Okun, MD, Abbott

Publications and helpful links

General Publications

• 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.

Helpful Links

• prescribing information

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: August 13, 2008
• First Submitted That Met QC Criteria: August 14, 2008
• First Posted (Estimate): August 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 1, 2010
• Last Update Submitted That Met QC Criteria: October 11, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: M10-405