Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet
This study has been completed.
Information provided by (Responsible Party):
Jennifer Soung, MD, University of California, Irvine
First received: December 26, 2007
Last updated: October 5, 2011
Last verified: October 2011
The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week affects plaque psoriasis of the hands and/or feet (Palmoplantar Psoriasis)
Other: Placebo injections
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Double-blind, Randomized, Placebo-controlled Study of Recombinant Human Tumor Necrosis Factor Receptor (p75) Fusion Protein Etanercept (Enbrel) in Patients With Moderate to Severe Plaque Psoriasis of the Hands and/or Feet
Primary Outcome Measures:
- The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4.. The sum of all three severity parameters is then calculated based on surface area affected.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2008 (Final data collection date for primary outcome measure)
Experimental: Treatment Group
Etanercept (Enbrel)50mg twice weekly injections for 12 weeks
Subcutaneous injections 50 mg Entercept or placebo will occur twice weekly over the first 12-week treatment period. At the end of the first 12 weeks, all subjects will be treated with etanercept 50 mg twice a week for an additional 12 weeks.
Other Name: Enbrel
Placebo Comparator: Placebo Group
Other: Placebo injections
Placebo injections twice weekly for first 12 weeks
This 24-week multicenter study consists of two phases. The first phase is a 12 week, double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects with PPP. Subjects who meet the eligibility criteria will be randomized to either 50 mg etanercept twice weekly or placebo. Subcutaneous injections will occur twice weekly at approximately the same time of day over the first 12-week treatment period. The primary efficacy endpoint will be assessed after 12 weeks of treatment. At the end of the first 12 weeks, all patient (both treatment and placebo arms) will be treated with etanercept 50 mg twice a week (BIW) for an additional 12 weeks.
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Moderate to severe palmar plantar psoriasis based on physician's global assessment (PGA).
- Between 18 and 70 years of age
- Negative urine pregnancy test at screening and at baseline
- Sexually active men and women of child-bearing potential must agree to use a medically accepted form of contraception (birth control) during the exclusionary medicine wash-out period and throughout the study.
- Ability to self inject study drug or have a designee who can do so
- Capable of understanding and giving written voluntary informed consent
- Previous treatment with Enbrel® (etanercept) or similar drugs
- Receipt of investigational drugs or "biologics" within 4 weeks of the screening visit.
- Evidence of skin conditions (e.g. eczema) other than psoriasis that would interfere with evaluations of the study medication.
- Receipt of any biologic medication within the previous 6 months that resulted in a decreased white blood cell count (cells to help fight infections)
- Ultraviolet light treatment (e.g. UVB, PUVA) within one month prior to study drug initiation.
- Receipt of immune-suppressing drugs other than Rheumatrex® (methotrexate) or Soriatane® (acetretin) within 4 weeks prior to the first dose of study drug. Medications you would not be allowed to take during this study include for example, Cytoxan® (cyclosporine), Imuran® (azathioprine), or Sulfazine® (sulfasalazine). If you remain on Rheumatrex® (methotrexate) (≤25 mg/week) or Soriatane® (acitretin) (≤50 mg/day), you must be considered to have inadequate disease control in the opinion of the investigator based on physician's global assessment. You must have been on a stable dose of systemic treatment for at least 1 month prior to the start of the study medication. You will be required to maintain a stable dose of the systemic treatment throughout the study.
- Use of topical steroids in the past 14 days unless they have been used for longer than 14 days and the severity of disease allows entry into study.
- Systemic steroid use (prednisone, etc).
- Prior or concurrent use of Cytoxan® (cyclophosphamide).
- Elevated liver tests; red blood cell count less than normal; decreased platelet count (cells to help with blood clotting); decreased white blood cell count (cells to fight infection); kidney insufficiency
- Any severe adverse event, infection or abnormal laboratory value at the time of the screening visit that would preclude participation in the study
- Presence of a severe infection, less than 30 days prior to the screening visit or between the screening visit and the first dose of study drug
- Pregnant or breast-feeding females.
- Significant concurrent medical diseases including: Uncompensated congestive heart failure (heart is unable to pump as normal): Myocardial infarction (heart attack) within 12 months of screening period; Unstable or stable angina pectoris (chest pains related to your heart); Uncontrolled high blood pressure
- Severe lung disease requiring medical or oxygen therapy
- History of cancer (other than surgically removed skin cancer and in situ cervical cancer) within 5 years of the screening visit
- History of tuberculosis
- Known to be HIV positive
- Rheumatoid arthritis
- Any neurologic demyelinating disease (such as multiple sclerosis or any neurologic disease causing loss of sensation or loss of normal movement) or seizure disorder
- Current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent.
- History of alcohol or drug abuse.
- Not up-to-date with all immunizations in agreement with the current immunization guidelines
- Significant exposure to the varicella virus (chicken pox)
- Guttate or generalized pustular psoriasis
- Surgery or trauma within a month of baseline considered by the investigator to represent a significant risk or interfere with patient evaluation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585650
|UC Irvine Dermatology Clinical Research Center
|Irvine, California, United States, 92697 |
|Wake Forest University School of Medicine
|Winston-Salem, North Carolina, United States, 27157 |
|Dermatology Associates, PLLC
|Seattle, Washington, United States, 98101 |
University of California, Irvine
||Gerald D Weinstein, M.D.
||University of California, Irvine
No publications provided
||Jennifer Soung, MD, Senior clinical research coordinator, Dermatology, University of California, Irvine
History of Changes
|Other Study ID Numbers:
||2006-5092, Amgen Protocol 20060514
|Study First Received:
||December 26, 2007
|Results First Received:
||May 12, 2011
||October 5, 2011
||United States: Food and Drug Administration
Keywords provided by University of California, Irvine:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Skin Diseases, Papulosquamous
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents