Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Etanercept (GP2015) and Enbrel

PHASE3CompletedINTERVENTIONAL
Enrollment

531

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

June 30, 2014

Study Completion Date

March 31, 2015

Conditions
Chronic Stable Plaque Psoriasis
Interventions
DRUG

GP2015 Etanercept

Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.

DRUG

Enbrel

Enbrel is used as reference product to GP2015.

Trial Locations (74)

Unknown

Sandoz Investigational Site, Pleven

Sandoz Investigational Site, Plovdiv

Sandoz Investigational Site 1, Sofia

Sandoz Investigational Site 2, Sofia

Sandoz Investigational Site 3, Sofia

Sandoz Investigational Site, Olomouc

Sandoz Investigational Site, Prague

Sandoz Investigational Site, Ústí nad Labem

Sandoz Investigational Site 1, Tallinn

Sandoz Investigational Site 2, Tallinn

Sandoz Investigational Site 3, Tallinn

Sandoz Investigational Site 1, Tartu

Sandoz Investigational Site 2, Tartu

Sandoz Investigational Site 1, Berlin

Sandoz Investigational Site 2, Berlin

Sandoz Investigational Site 1, Dresden

Sandoz Investigational Site 2, Dresden

Sandoz Investigational Site, Kiel

Sandoz Investigational Site, Lübeck

Sandoz Investigational Site, Munich

Sandoz Investigational Site, Budapest

Sandoz Investigational Site, Debrecen

Sandoz Investigational Site, Gyula

Sandoz Investigational Site, Szolnok

Sandoz Investigational Site, Gdansk

Sandoz Investigational Site, Gdynia

Sandoz Investigational Site, Katowice

Sandoz Investigational Site 1, Krakow

Sandoz Investigational Site 2, Krakow

Sandoz Investigational Site 1, Lodz

Sandoz Investigational Site 2, Lodz

Sandoz Investigational Site 3, Lodz

Sandoz Investigational Site 4, Lodz

Sandoz Investigational Site, Poznan

Sandoz Investigational Site, Rzeszów

Sandoz Investigational Site, Warsaw

Sandoz Investigational Site, Wroclaw

Sandoz Investigational Site, Zgierz

Sandoz Investigational Site, Brasov

Sandoz Investigational Site 1, Bucharest

Sandoz Investigational Site 2, Bucharest

Sandoz Investigational Site 3, Bucharest

Sandoz Investigational Site, Cluj-Napoca

Sandoz Investigational Site 1, Iași

Sandoz Investigational Site 2, Iași

Sandoz Investigational Site, Târgu Mureş

Sandoz Investigational Site, Timișoara

Sandoz Investigational Site, Saint Petersburg

Sandoz Investigational Site, Smolensk

Sandoz Investigational Site, Banská Bystrica

Sandoz Investigational Site, Bojnice

Sandoz Investigational Site 1, Bratislava

Sandoz Investigational Site 2, Bratislava

Sandoz Investigational Site, Kosice-Saka

Sandoz Investigational Site, Košice

Sandoz Investigational Site, Nitra

Sandoz Investigational Site, Svidník

Sandoz Investigational Site, Bloemfontein

Sandoz Investigational Site, Krugersdorp

Sandoz Investigational Site 1, Pretoria

Sandoz Investigational Site, Worcester

Sandoz Investigational Site, Dnipropetrovsk

Sandoz Investigational Site, Donetsk

Sandoz Investigational Site, Kharkiv

Sandoz Investigational Site, Kyiv

Sandoz Investigational Site, Luhansk

Sandoz Investigational Site, Rivne

Sandoz Investigational Site, Simferopol

Sandoz investigational Site, Zaporizhzhia

Sandoz Investigational Site, Dundee

Sandoz Investigational Site, Leeds

Sandoz Investigational Site, London

Sandoz Investigational Site, Newcastle upon Tyne

Sandoz Investigational Site, Salford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Hexal AG

INDUSTRY

lead

Sandoz

INDUSTRY