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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00735787
First received: August 13, 2008
Last updated: October 11, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Psoriasis
Biological: Placebo
Biological: Adalimumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 ] [ Designated as safety issue: No ]
    Number of subjects that achieved > 50% reduction from Baseline in ESIF.

  • Number of Subjects With Marked Improvement in ESIF From Baseline [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28 ] [ Designated as safety issue: No ]
    Number of subjects that achieved > 75% reduction from Baseline in ESIF

  • Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) [ Time Frame: Baseline and Weeks 8, 16, and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 16 and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 16 and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 16 and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 16 and 28 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Weeks 2, 8, 16, and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 2, 8, 16, and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 16 and 28 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Weeks 8, 16, and 28 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Weeks 2, 8, 16, and 28 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Weeks 2, 8, 16, and 28 ] [ Designated as safety issue: No ]
    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).


Enrollment: 81
Study Start Date: August 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Humira
  • ABT-D2E7
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:
  • Humira
  • ABT-D2E7

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735787

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

Additional Information:
No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martin Okun MD, Director, Abbott
ClinicalTrials.gov Identifier: NCT00735787     History of Changes
Other Study ID Numbers: M10-405
Study First Received: August 13, 2008
Results First Received: September 1, 2010
Last Updated: October 11, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2014