Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Psoriasis

In brief

The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).

Key facts

Study ID

NCT00585650

Run by

University of California, Irvine

People needed

20

Starts

2007-05-01

Expected to finish

2008-05-01

Last updated by the study team

2023-08-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Irvine Dermatology Clinical Research Center — Irvine, California, United States
• Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
• Dermatology Associates, PLLC — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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