CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Etanercept +1 morebiological
Likely dose
Etanercept 50 mg subcutaneous injection twice weekly for 12 weeksAI-extracted
Key inclusion· 4
  • Moderate to severe palmar plantar psoriasis diagnosed by physician's global assessment (PGA)
  • Age 18-70 years
  • Able to self-inject study drug or have someone administer it
  • Willing to use medically accepted contraception if sexually active and of child-bearing potential
Key exclusion· 12
  • Prior treatment with etanercept or similar drugs
  • Biologic medication within 6 months that caused decreased white blood cell count
  • Immune-suppressing drugs (other than methotrexate ≤25 mg/week or acitretin ≤50 mg/day) within 4 weeks prior to first dose
  • UV light treatment (UVB, PUVA) within 1 month prior to study drug initiation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00585650
NCT00585650Phase 2Completed

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

University of California, Irvine·interventional·Posted Jan 3, 2008·Updated Aug 18, 2023

In Brief

A Phase 2 clinical trial evaluating Etanercept and Placebo injections for Psoriasis. Completed, enrolled 20 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesUnited States
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 3, 2008
Enrollment StartMay 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 18.5 years ago

Interventions

Etanerceptbiological

Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period.

Placebo injectionsother

Placebo injections twice weekly for 12 weeks.