MYL-1401A Efficacy and Safety Comparability Study to Humira®

PHASE3CompletedINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

March 31, 2017

Conditions
PsoriasisArthritis, Psoriatic
Interventions
BIOLOGICAL

MYL-1401A (Adalimumab)

MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose

BIOLOGICAL

Humira® (Adalimumab)

Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose

Trial Locations (33)

Unknown

Mylan Investigational Site 102, Plovdiv

Mylan Investigational Site 105, Plovdiv

Mylan Investigational Site 101, Sevlievo

Mylan Investigational Site 100, Sofia

Mylan Investigational Site 103, Sofia

Mylan Investigational Site 107, Tallinn

Mylan Investigational Site 108, Tallinn

Mylan Investigational Site 109, Tallinn

Mylan Investigational site 110, Tallinn

Mylan Investigational Site 106, Tartu

Mylan Investigational SIte 112, Tartu

Mylan Investigational Site 127, Budapest

Mylan Investigational Site 128, Budapest

Mylan Investigational Site 125, Debrecen

Mylan Investigational Site 129, Gyula

Mylan Investigational Site 126, Szekszárd

Mylan Investigational Site 131, Bialystok

Mylan Investigational Site 137, Bialystok

Mylan Investigational Site 135, Iwonicz-Zdrój

Mylan Investigational Site 140, Krakow

Mylan Investigational Site 139, Lodz

Mylan Investigational Site 133, Olsztyn

Mylan Investigational Site 138, Poznan

Mylan Investigational Site 136, Warsaw

Mylan Investigational Site 130, Wroclaw

Mylan Investigational Site 132, Wroclaw

Mylan Investigational Site 134, Wroclaw

Mylan investigational site 156, Kazan'

Mylan Investigational site 155, Penza

Mylan Investigational Site 148, Ryazan

Mylan Investigational Site 149, Saint Petersburg

Mylan Investigational site 159, Kharkiv

Mylan investigational site 161, Uzhhorod

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Mylan GmbH

INDUSTRY

lead

Mylan Inc.

INDUSTRY