Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
- Conditions
- Psoriasis
- Interventions
- Biological: PlaceboBiological: Adalimumab
- Registration Number
- NCT00735787
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo/Adalimumab Placebo 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. Placebo/Adalimumab 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. Adalimumab 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.
- Primary Outcome Measures
Name Time Method Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 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
Name Time Method Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 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 Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28 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 Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 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 Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 Number of subjects that achieved \> 50% reduction from Baseline in ESIF.
Number of Subjects With Marked Improvement in ESIF From Baseline Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 Number of subjects that achieved \> 75% reduction from Baseline in ESIF
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Baseline and Weeks 8, 16, and 28 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 Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28 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 Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28 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 Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28 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 Baseline and Weeks 16 and 28 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 Baseline and Weeks 16 and 28 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 Baseline and Weeks 16 and 28 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 Baseline and Weeks 16 and 28 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) Baseline and Weeks 2, 8, 16, and 28 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 Baseline and Weeks 2, 8, 16, and 28 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 Baseline and Weeks 16 and 28 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) Baseline and Weeks 8, 16, and 28 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) Baseline and Weeks 2, 8, 16, and 28 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 Baseline and Weeks 2, 8, 16, and 28 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).
Trial Locations
- Locations (17)
Site Reference ID/Investigator# 10173
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 10175
🇨🇦Waterloo, Ontario, Canada
Site Reference ID/Investigator# 10005
🇺🇸Bakersfield, California, 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# 10180
🇨🇦Edmonton, Alberta, Canada
Site Reference ID/Investigator# 10166
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 10004
🇨🇦London, Ontario, Canada
Site Reference ID/Investigator# 10169
🇨🇦Vancouver, British Columbia, Canada
Site Reference ID/Investigator# 10177
🇨🇦North Bay, Ontario, Canada
Site Reference ID/Investigator# 10165
🇨🇦Montreal, Quebec, Canada
Site Reference ID/Investigator# 10179
🇨🇦Hamilton, Ontario, Canada
Site Reference ID/Investigator# 10170
🇨🇦Halifax, Nova Scotia, Canada
Site Reference ID/Investigator# 10176
🇨🇦Quebec, Canada
Site Reference ID/Investigator# 10168
🇺🇸Little Rock, Arkansas, United States
Site Reference ID/Investigator# 10003
🇺🇸Macon, Georgia, United States
Site Reference ID/Investigator# 10171
🇺🇸St. Louis, Missouri, United States