CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 174 enrolled
Drug / intervention
etanercept +1 moredrug
Likely dose
etanercept 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00992394
NCT00992394Phase 4Completed

Randomized Open-label Study Comparing 2 Different Strategies For Management Of Subjects With Plaque Psoriasis Who Have Responded To Etanercept Treatment

Pfizer·interventional·Posted Oct 9, 2009·Updated Jan 8, 2016

In Brief

A Phase 4 clinical trial evaluating etanercept for Psoriasis. Completed, enrolled 174 participants across 46 sites in 9 countries.

Detailed Summary

This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment. The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
CountriesFrance, Germany, Greece, Hungary, Italy, Spain, Turkey (Türkiye), United Arab Emirates, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 9, 2009
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.7 years ago

Interventions

etanerceptdrug

etanercept 50 mg once weekly as requested.

etanerceptdrug

etanercept 25 mg or 50 mg as requested.