Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Ha… (NCT00585650) | Clinical Trial Compass
CompletedPhase 1/2
Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet
United States20 participantsStarted 2007-05
Plain-language 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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested etanercept specifically for psoriasis on the hands and feet using something called the Palmoplantar Psoriasis Severity Index — how did patients in this study actually do at the 12-week mark, and what does that mean for someone with my particular pattern of psoriasis?
2Since this was a Phase 1/2 trial, the main focus was on early safety and dosing rather than proving the treatment works — what does that mean for how confident we can be about the risks and benefits of etanercept for palmoplantar psoriasis specifically?
3Etanercept is already an approved medication for plaque psoriasis more broadly — would it make more sense for me to try it through a standard prescription first, rather than looking at data from this earlier-phase study?
4Palmoplantar psoriasis can be really debilitating for daily life and work — based on what this trial found at 12 weeks, is a 50% improvement in severity a realistic goal, and how would we know if I was responding well enough to continue?
5Are there other completed or ongoing trials for hand and foot psoriasis that have gotten further along — maybe Phase 3 — that might give us stronger evidence to guide my treatment decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks.