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Phase 2 N=20 Randomized Double-blind Treatment

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

Psoriasis

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks. — 8; 12 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Etanercept (Biological); Placebo injections (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of California, Irvine
Primary completion
May 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks.
8; 12

Summary

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).

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00585650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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